| Job List |
| Job ID: |
DS-01108-3 - Associate Director, Clinical Affairs |
| Description: |
This is a biopharmaceutical company dedicated to developing breakthrough biologic medicines in the area of oncology. The Company has utilized the many advances made in the fields of molecular biology, oncology, genomics, and antibody engineering to build a novel pipeline of product candidates designed to address specific genetic mechanisms involved in cancer growth and development.
Their goal is to become a fully-integrated biopharmaceutical company that has the capability and resources to take its novel pipeline compounds and develop them from the research and development stage through to commercial manufacture, marketing and sales. With their first innovative cancer drug on the market and late stage clinical candidates soon to be, they have cooperative agreements with several big pharmaceutical companies to help market their drugs. A solid, fast growing midsized company which incorporates the best of both worlds, security with room to grow.
Currently looking for an: Associate Director, Clinical Affairs
GENERAL SUMMARY
Directs the conduct of assigned clinical investigations and activities associated with it. Performs assigned responsibilities to ensure timely completion of departmental goals and objectives. Prepares and distributes ad hoc reports, summaries, analyses. Participates in the periodic review and revision of departmental policies and SOPs to ensure compliance with corporate policies, GCPs, or regulations involving governmental agencies. Has direct involvement with the selection of new hires. Trains, develops and supervises clinical staff.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Directs the conduct of assigned clinical investigations and activities associated with it.
Supervises training programs to assure consistency and compliance in monitoring of clinical investigations.
Prepares and distributes ad hoc reports, summaries, or analyses as required. Prepares status reports for assigned clinical investigations.
Prepares drug usage projections and tracking for assigned clinical investigations as requested.
Participates in the periodic review and revision of departmental policies and SOPs to ensure compliance with corporate policies, good clinical practice procedures (GCPs), or regulations of governmental agencies.
Has direct involvement in the selection process of new hires, including reviewing candidates credentials, interviewing candidates, and making hiring recommendations.
May assist with preparation and execution of Investigator meetings.
Prepares department budgets, timelines, and project plans.
Maintains professional skills by keeping abreast of literature, attending conferences, courses and meetings.
Maintains knowledge of U.S. and foreign regulations, guidelines, policies and practices for conducting clinical investigations.
Follows departmental policies, procedures and SOPs .
Trains, develops and supervises clinical staff.
Negotiates contracts and budgets for assigned clinical investigations..
Develops and reviews study protocols and CRFs.
Participates in internal/external audits.
Responsible for producing final study reports.
Participates in dissemination of clinical information to the clinical team members, as appropriate.
Provides leadership and assists as appropriate in managing the clinical research department in an effective manner.
Serves on cross teams for evaluation of new clinical research strategies.
May act as a company spokesperson regarding publication and presentations of clinical research findings.
Coordinates cross functional efforts to improve clinical development. Identifies issues that may impact the overall project plans and initiates contingency plans as appropriate.
Directs departmental resource planning, budgeting, and timeline setting to meet the companies needs.
Provides clinical support in working with the FDA, including the 510(k), and pre-market approval submissions and responses to FDA questions.
ESSENTIAL KNOWLEDGE, SKILLS AND EXPERIENCE
7-10 years experience of progressively increasing clinical research experience within the pharmaceutical industry.
Experience in drug development, especially Food and Drug Administrations regulations and Good Clinical Practices or Associates of Clinical Pharmacology CRA certification.
Experience in IND/NDA/BLA submissions.
An advanced degree (M.S. or PharmD) is preferred. A minimum academic degree in Nursing (R.N. or B.S.N.), Life Sciences (B.A. or B.S.), Pharmacy or Medicine. Experience requirements may be less with advanced degrees.
Excellent problem solving and team building skills.
Ability to resolve and make judgements regarding administrative, scientific and/or clinical problems with minimal supervision.
Ability to deliver oral presentations and write in a clear, focused, and concise manner.
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Salary: to 130k,
Job Type: Permanent,
Total Exp: 7-10 Yrs,
Start Date: ASAP,
Location: Branchburg, NJ |
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| Job ID: |
TB-07277-2 - Associate Director/ Director Clinical Affairs |
| Description: |
Summary
Provide leadership and supervision to the Clinical Affairs group in NY office. Responsibilities include client interaction; defining project requirements, deliverables, schedules and budgets; managing project schedules and budgets; promoting SOP and policy compliance; monitor resource needs; staff management, promoting the use of tools and metrics.
Essential Duties and Responsibilities include the following. Other duties may be assigned.
Develop and manage the project management department including, but not limited to the following
areas.
Manage:
-Consistency of project management and clinical monitoring regarding project requirements, deliverables, schedules and budgets.
-Communication with clients and Client Project Managers to promote project schedule adherence, ensure that projects are adequately staffed with personnel and resources, and meet high quality standards.
-Development and maintenance of operations and procedure manuals, work guidelines, department metrics and project tools.
Coordinate training and education programs to ensure staff is trained as needed, including but not limited to relevant therapeutic areas, ICH guidelines, and regulatory requirements
Assist with managing and monitoring the departmental budget. Monitor department billable percentages.
Work closely with clinical project managers to promote operational efficiency, teamwork, and high morale.
Interact with clients in a customer service role and to ensure solid team relations.
Collaborate with staff inter and intra-departmentally on the proposal development process.
Assist in Operations meetings and directives to improve department and corporate policies and procedures.
Supervise projects involving monitoring, database management, data management/entry, programming, statistics, report writing, and agency presentations.
Make presentations and represent company at professional meetings and to prospective and existing clients.
Manage personnel activities, and provide guidance for professional development of staff (coordinate resource distribution across projects, interviews, makes hiring recommendations, leads disciplinary actions, delivers performance reviews.)
Additional Duties and Responsibilities:
Act as back-up for project managers.
Qualification Requirements: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to individuals with disabilities to perform the essential functions.
Education and/or Experience:
BS/BA. 5 years industry experience including and at least 5 years clinical trial experience; minimum 5 years project and /or team management experience.
Other Skills and Abilities:
Must have strong leadership and management skills. Must have the ability to handle multiple projects simultaneously and manage multi-functional teams; must have creative problem solving skills; excellent verbal / written communication skills. Must have strong computer skills. Must have strong time management and organizational skills. Must have excellent knowledge of at least two departmental processes and functions within the Pharmaceutical Industry and drug development process.
Preferred Qualifications
Advanced degree; 5+ years project management experience within a CRO; 5+-years management experience.
Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Some stress may occur. Some travel may be required. No special physical demands required.
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. This is an in-house position.
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Salary: 120-145K,
Job Type: Permanent,
Total Exp: 5+ Yrs,
Start Date: ASAP,
Location: Rye Brook, NY |
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| Job ID: |
PCR-10027-1 - Associate Director/Director of Clinical Research |
| Description: |
The successful candidate will join an exciting fast-paced department with active clinical development programs within the Oncology area.
This includes all phases of clinical development, including study design, study placement, study monitoring and concern for the protection of human subjects participating in clinical trials. Additionally, this person will be responsible for the analysis and summary of clinical findings from studies for the purpose of decisions regarding safety and efficacy to support new drug submissions, new drug applications or clinical experience reports, as well as serving as a member of appropriate research project teams.
The company's Oncology effort has a particular focus on the use of molecular profiling to identify specific populations of patients most likely to benefit from our novel therapies. Translational research molecular profiling projects are performed in close collaborations with scientists.
The qualified candidate will possess an M.D. or M.D./PhD, plus Board Certification or eligibility. Those with a PhD and substantial post-doctoral experience will also be considered. Experience in industry or academia, a demonstrated record of scientific scholarship and achievement, a proven track record in clinical medicine and a background in biomedical research are essential.
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Salary: OPEN,
Job Type: Permanent,
Total Exp: 6 Yrs,
Start Date: ASAP,
Location: Upper Gwynedd, PA |
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| Job ID: |
TRS-02158-15 - Associate Director/Director, Sepsis and Anti-Infectives |
| Description: |
Description:
The incumbent is responsible for, but not limited to the following:
Primarily focusing on Infectious disease
Supporting the Sepsis/AI area function and strategy
Leading problem solving across the Sepsis/AI area with an enterprise-wide perspective: facilitating team(s) to identify issues and propose solutions
Contributing to development results by providing Sepsis/AI area leadership to assume a supervisory and/or "subject matter expert" role with regard to therapeutic area issues.
Bringing external market perspectives, sharing insight, and knowledge regarding therapeutic areas with groups within own department and across Eisai, as appropriate
Providing technical insight to ensure progress towards goals
Lead IPT or Study Teams, as appropriate
Qualifications:
MD, PhD or equivalent degree required
At least 3-5 years additional related experience for an MD or 7-10 years for a PhD (including academic research)
Experience in a field relating to Sepsis/AI
Medical expertise and development experience within an area relevant to Sepsis/AI especially as related to infectious diseases
Significant experience leading clinical trials
Working knowledge of other functional areas (e.g., Clinical Operations, Regulatory Affairs, Pre-clinical and Marketing)
Experience in translational research, working with pre-clinical scientists, leading study/project teams
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Salary: Open,
Job Type: Permanent,
Total Exp: 3-5,
Start Date: ASAP,
Location: Ridgefield Park, NJ |
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| Job ID: |
TRS-02158-4 - Associate Director/Senior Manager, Drug Regulatory Affairs C |
| Description: |
Description:
The incumbent os responsible for, but not limited to the following:
Support commercial and corporate marketed products initiatives
Development of CMC dossiers and registration strategies in support of commercial objectives
Assessment of change proposals for marketed products and serve as the US Regulatory Representative on Commercial Change Control Committee
Liaise and negotiate with FDA Review and Compliance divisions as necessary
Provide Regulatory support during FDA pre-approval inspections
Qualifications:
B.S. degree in pharmacy, chemistry or a related discipline required, advanced degree (MS, PhD) strongly preferred
5 or more years of Regulatory CMC experience specifically supporting commercial operations
Experience interacting directly with the FDA
Experience in biologics is highly derirable. |
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Salary: Open,
Job Type: Permanent,
Total Exp: 5-7 Yrs,
Start Date: ASAP,
Location: Ridgefield Park, NJ or RTP, NC |
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| Job ID: |
DS-09247-2 - Associate Research Scientist |
| Description: |
This Company, located in Tarrytown, NY, is a biopharmaceutical company focusing on the development and commercialization of innovative therapeutic products to treat the unmet medical needs of patients with debilitating conditions and life-threatening diseases. Principal programs are directed toward gastroenterology as well as the treatment of HIV infection and cancer.
They offer a wide-range of opportunities for highly motivated employees, who set their goals high, will find that the rewards may exceed their expectations. Their vision for a bright and prosperous future sets the stage for energetic, creative professionals to join us and contribute to our success. They currently employ individuals with a variety of backgrounds including scientific, clinical research, manufacturing and regulatory. Their growth depends on developing and energizing the talents of new and current employees.
Responsibilities:
Perform mammalian cell culture
Perform cell-based assays such as ADCC and CMC
Conduct characterization of monoclonal antibodies via a wide range of biochemical assays such as ELISA, SDS-PAGE, Western Blot, FACS, Biacore, SEC-HPLC
Play a lead hands-on role in evaluation and selection of preclinical candidates of monoclonal antibodies for product development
Conduct in vivo xenograft animal studies
Precise and accurate experimental record keeping
Write investigations and charge reports when required.
Requirements:
Requires an MS/MA degree with 1-3 years hands-on experience within a biopharmaceutical R& D organization, and industry experience.
Experience in mammalian cell culture, antibody evaluation and characterization including cell-based assays such as ADCC and CMC.
Demonstrates technical expertise in performing a variety of experimental techniques, and designating routing experiments while troubleshooting basic problems.
Requires strong interpersonal, oral and written communication skills. Highly motivated, organized and eager to learn.
Technical Requirements:
Candidates must have hands-on experience in cell culture and protein/antibody characterization (ADCC, CMC, FACS, ELISA, SDS-PAGE) and industry experience
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Salary: 52-65K,
Job Type: Permanent,
Total Exp: 1-3 Yrs,
Start Date: ASAP,
Location: Tarrytown, NY |
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| Job ID: |
TRS-02158-16 - Associate Vice President - Global Therapeutic Area Head, On |
| Description: |
Description:
The chosen incumbent shall be responsible for but not limited to:
- Building an effective Oncology area to achieve business objectives.
- Providing input and support Oncology business strategy with an enterprise-wide perspective and contribute to its outcome.
- Responsible for organization and successful operating of advisory boards as necessary.
- Making Oncology area decisions with an organization-wide perspective.
- Act as a role model teamwork/collaboration in decision making process with respect to Oncology area decisions and process.
- Aligning business and Oncology area objectives across multiple project teams, departments, functions, and Eisai business units.
- Building a national/international reputation for excellence within the Oncology field.
- Oversight of the Oncology Therapeutic Area Globally.
- Working closely with marketing, business development and pre clinical research groups.
Qualifications:
- MD with training in Oncology.
- Minimum 10 years experience (including academic and industry).
- Minimum 2-3 years experience running a Therapeutic area or equivalent group with responsibility for multiple drug trials preferred.
- Proven ability to effectively interact with pre-clinical groups on complex scientific issues relating to the Oncology area required.
- Experience in entire clinical drug development process, including FDA/EMEA filing and product launches preferred.
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Salary: Open,
Job Type: Permanent,
Total Exp: 3-5 Yrs,
Start Date: ASAP,
Location: Ridgefield Park, NJ |
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| Job ID: |
RG-11267-7 - Clinical Logistics Manager |
| Description: |
The Clinical Logistics Manager will provide appropriate oversight of critical Clinical Operations functions necessary to successfully implement and conduct clinical trials. This will include responsibility for, and is not limited to, clinical drug supply management, trial logistics and clinical document archiving.
Essential Duties and Responsibilities include, but are not limited to the following:
-esponsible for managing the day-to-day activities in the Clinical Operations/ Logistics group for the following functions:
-Medical Logistics (central laboratory set-up, sample assay group liaison, RFI/RFP support) -Clinical Drug Supply (drug supply projections, drug shipment requests and disposition to/from clinical sites, medical supply management)
-Trial Master Files (document filing and long-term archiving)
-Other Clinical Operations activities.
Responsibilities to Clinical Logistics staff include:
-Manage staff's daily activities
-Set priorities
-Training and development.
Responsibilities to Clinical Development organization:
-Individual will be a working manager
-Clinical Logistics Manager will work with the Clinical development teams to understand specific trials needs
-Work with Clinical Logistics staff to implement plans -Document processes through Work Instructions and/or SOPs, as appropriate
-Develop and track metrics related to processes and staff
-Provide status updates and information to Senior Director Clinical Operations and other Clinical management on a regular basis.
Knowledge and Specialized Skills:
Knowledge and experience in the clinical research process and ICH/GCP Regulations and Guidelines. Analytical problem solving skills. Effective communication skills; both on an interpersonal level and in large or small group settings. Proven ability to communicate (written and verbal) with other departments, across disciplines and with vendors utilizing all means of communication (email, telecon, telephone). Must be able to work proactively and independently and have had experience with "virtual teams." Will manage a small staff of Clinical Operations and Logistics specialists.
Education and Experience:
A Bachelors degree (BS) from an accredited college or university plus five (5) or more years of industry-related experience is required. A Masters degree (MS) and three (3) or more years of experience is also accepted. Experience managing clinical research professionals is required.
Relocation Plan Available. |
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Salary: to 110k,
Job Type: Permanent,
Total Exp: 5 Yrs,
Start Date: ASAP,
Location: Tarrytown, NY |
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| Job ID: |
PC-05167-1 - Clinical Protocol Manager |
| Description: |
Job Description: Drives the successful execution of a protocol using strong management and organizational skills. Monitors protocol progress and addresses and manages obstacles. Serves as primary contact for the protocol. Coordinates the development of protocol level documents and plans. Effectively leads a global team of individuals assigned to the protocol.
Experience Requirements: Strong project management skills. Strong interpersonal and influencing skills. Proven teambuilding skills and ability to foster partnerships across projects and multidisciplinary teams. Effective oral and written communication skills to influence, inform or guide others. 3-5 years project management experience in pharmaceutical or CRO setting managing clinical studies.
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Salary: Open,
Job Type: Permanent,
Total Exp: 3-5 Yrs,
Location: Wallingford, CT |
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| Job ID: |
PC-05167-2 - Clinical Protocol Manager |
| Description: |
Job Description: Drives the successful execution of a protocol using strong management and organizational skills. Monitors protocol progress and addresses and manages obstacles. Serves as primary contact for the protocol. Coordinates the development of protocol level documents and plans. Effectively leads a global team of individuals assigned to the protocol.
Experience Requirements: Strong project management skills. Strong interpersonal and influencing skills. Proven teambuilding skills and ability to foster partnerships across projects and multidisciplinary teams. Effective oral and written communication skills to influence, inform or guide others. 3-5 years project management experience in pharmaceutical or CRO setting managing clinical studies.
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Salary: Open,
Job Type: Permanent,
Total Exp: 3-5 Yrs,
Location: Lawrenceville, NJ |
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| Job ID: |
TI-07117-1 - Clinical Scientist |
| Description: |
The Clinical Research Scientist role, reports to the Senior Director, Clinical Research and Development - Candidate will assist in the planning, implementation, managing, and reporting of clinical trials. The CRS will prepare/review clinical trial synopses and protocols, Investigator Brochures, and clinical study reports; review SAPs and tables, listings, and figure shells; assist with data interpretation and data mining; ensure that assigned studies are conducted according to GCPs and Departmental SOPs; assist in conducting literature searches/reviews, meta-analyses, and publishing data; provide scientific expertise to product teams; contribute to the preparation of IND/NDA medical sections; support business development activities by evaluating new product potential; and will assist in the review of clinical study entries (clinical trial information and results) for posting to the company's CTRR (Clinical Trial Registry and Results) database/TPR (Third Party Registry).
The position requires an advanced degree (Dr.P.H., Pharm.D., Ph.D., Sc.D.) as well as experience in pharmaceutical research, specifically exposure to the IND/NDA approval process and Phase I, II, III and IV clinical research. The incumbent should have at least 3+ years of directly related pharmaceutical clinical research experience. The position requires research administration experience, knowledge of scientific principles of controlled trials, and a comprehensive knowledge of FDA and ICH guidelines. Excellent human relations and communication (written and oral) skills are required. This position also requires a working knowledge of software packages (e.g., MS Word, MS Excel, MS Project, MS Access, JMP). The abilities to work on a team, cooperate with colleagues, and effectively communicate with a diverse audience, at multiple levels, both inside and outside the company, are essential. A capability to work with cross-functional teams at the protocol and clinical program level is mandatory. The incumbent must have demonstrated experience in clinical research, study trial management, clinical database maintenance, generation of research hypotheses, and publication and presentation of scientific information. Professionalism, objectiveness, critical thinking, evidence-based reasoning, and a positive outlook are of the utmost importance. CNS-, pain-, and/or neurology/neuroscience-related research experience is highly desirable. Travel up to 20% of the time may be required.
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Salary: 100-120K,
Job Type: Permanent,
Total Exp: 2 Yrs,
Start Date: ASAP,
Location: Chadds Ford, PA |
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| Job ID: |
PCR-05068-8 - Clinical Study Manager |
| Description: |
Description
The Clinical Study Manager (CSM) organizes and facilitates the overall planning, coordination, tracking and general performance of clinical studies that support the Clinical Development Plan. The CSM is responsible for ensuring clinical study quality/consistency of performance and in conjunction with the Clinical Leader and all other Team members is responsible for overall timeline adherence and performance against plan of the clinical study. A critical component of the position is the peer management and/or support of and coordination with contract research organization personnel (CROs), consultants, contractors, and other Purdue colleagues to ensure adequate resource volume and quality is maintained on the studies for which the CSM is responsible. At times, business travel will be necessary. The incumbent requires superior written and verbal communication skills, peer management skills and must have a well-defined, effective system for multi-tasking. There are numerous high-level deliverables for which the CSM is accountable to the study team. Incumbent will conduct the assigned activities (or manage the CRO) with minimal supervision in accordance with ICH/GCP/FDA guidelines, Purdue policies/SOPs/WPDs, and protocol specifications
Educational Requirements
BS/BA in a health-care or science related field
Years of Experience
Minimum of 5 years industry experience including 2 years as a site CRA and 2-3 years as a study / project manager for a CRO or pharmaceutical company.
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Salary: 90-105K,
Job Type: Permanent,
Total Exp: 5 Yrs,
Start Date: ASAP,
Location: Stamford, CT |
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| Job ID: |
GT-03318-2 - Clinical Trial Manager III |
| Description: |
Summary of Position:
The Clinical Trial Manager III is accountable for the day-to-day operations of 1-4 clinical trials commensurate with complexity, including trial start-up, conduct, and close-out activities.
Job Duties/Responsibilities:
- Performs job duties independently with minimal guidance from the Clinical Program Manager.
- Leads the Protocol Execution Team (PET) to ensure that trial timelines, costs, and quality metrics are met
- Serves as primary contact for functional area representatives in managing protocol execution
- Ensures accuracy and timeliness of vendor and site payments
- Oversees forecasting of clinical/non-clinical supplies
- Establishes study milestones and ensures accurate tracking and reporting of study metrics
- Manages trial-specific Genentech collaborations with other research entities (e.g., Cooperative Group Trials, Investigator Sponsored Trials, Global Partner Trials)
- Performs ongoing vendor management (e.g., CROs, IVRS, Reading Centers), including independent negotiation of vendors scope of works and budgets, performance management, and issue resolution
- Creates and manages clinical trial budgets and staffing/resourcing plans
- Provides study-specific direction and mentoring to Clinical Site Managers, Clinical Trial Associates and support staff as appropriate
- Provides support and mentoring to other Clinical Trial Managers
- Ensures trial adherence to ICH/GCP/local regulations
- Participates in clinical operations initiatives and programs as assigned
Competencies Identified for Success:
- Highly developed leadership skills to build and directs the Protocol Execution Team to ensure that timeline, cost and quality metrics are met
- Effective written and verbal communication skills
- Extensive experience developing trial plans including site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supplies management
- Extensive clinical research knowledge and cross-functional understanding of clinical trial methodology
- Collaborates effectively with the Clinical Operations study team, cross-functional team members, and external partners
Education, Experience, and Other Requirements:
- Bachelor's Degree with a minimum of eight years of clinical research experience
- Therapeutic knowledge preferred
- Knowledge of GCP and ICH
- Proficient computer skills
- Travel may be required |
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Salary: OPEN,
Job Type: Permanent,
Total Exp: 7-10 Yrs,
Start Date: ASAP,
Location: San Francisco, CA |
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| Job ID: |
TI-07117-4 - CNS Clinician (Associate Director/Director level) |
| Description: |
Qualifications: EDUCATIONAL BACKGROUND:
M.D. and board-certified in psychiatry or neurology.
WORK EXPERIENCE/SKILLS:
MINIMUM: Completion of medical and specialty training.
DESIRABLE:
- Strong inter-personal and persuasion skills are critical for success within the organization.
- Successful candidates will need to work with and lead others in novel approaches in the design and interpretation of clinical trials and programs.
- Expertise and experience in clinical trial design and interpretation preferred, as are expertise and experience in Alzheimers disease, schizophrenia, bipolar, depression, anxiety, or ADHD.
- Exceptionally creative, motivated, collaborative and scientifically motivated individuals sought.
Level will be determined by candidate's background and qualifications.
Responsibilities: The Clinician/Clinical Lead will work in a matrix team of clinical colleagues (other clinicians, statisticians and clinical pharmacologists) creating clinical development plans, designing and interpreting clinical trials and providing medical support during clinical trial conduct for one or more neuroscience drug development program(s). Depending upon the experience of the candidate and the level of drug program complexity, he/she may lead one or more clinical trials and support the creation of clinical development plans or may also lead (as Clinical Lead) the clinical sub-team of a drug program.
The clinician position will report to a more senior clinician within the clinical line. When serving in the role of Clinical Lead, he/she would also report to the Team Leader for the drug program. The successful candidate will need to be able to work across the entire development continuum, from providing clinical input to neuroscience research, to providing leadership for clinical trial and program design in early and late phase clinical development.
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Salary: OPEN,
Job Type: Permanent,
Total Exp: 4 Yrs,
Start Date: ASAP,
Location: Groton, CT |
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| Job ID: |
TB-01158-10 - Dir. of Clinical Research and Development |
| Description: |
1 opening Oncologist
1 opening Cardiologist
Relocation assistance
We are currently seeking a key MD to join our Clinical Group and provide clinical leadership to our Cardiovascular Development Programs. The Clinical Director reports to our Chief Medical Officer/SVP Clinical Research and Development. He/she will be chartered to provide medical guidance and leadership to all aspects of product development including clinical advisory board management, protocol design, clinical trial site recruitment/implementation and monitoring; as well as data interpretation and reporting. He/she will also support IND, Phase I-III and NDA submissions. Duties: Serves as a source of medical expertise for cardiovascular project teams. Provides input to decisions that have medical, scientific, and future marketing implications. Is responsible for the medical input to design, planning, initiation and completion of clinical trials. Responsible for the preparation of the medical components of study protocols and IND and other regulatory submissions. Responsible for establishing communications with prominent clinical investigators in the areas of and cardiovascular medicine. Attends appropriate scientific meetings to maintain awareness of research activities and represents a project and/or Company at such external events. Applies the strategic intent of the Company when working with regulatory bodies such as FDA, and with opinion leaders. Performs product safety medical reviews for assigned investigational drugs. Ensures an appropriate level of customer service to internal and external customers.
Requirements
MD degree with board certification in internal medicine with minimum of 3 years in clinical development experience in a biotechnology or pharmaceutical company. We would consider candidates with less/more industry experience at Associate Director/Sr. Director levels. Sub-specialty training and prior industry experience in the clinical development of cardiovascular therapeutics. Strong understanding of human pharmacology, biochemical medicine and pharmacodynamic/clinical endpoints. Expertise in clinical trials design and related statistical issues. Knowledge of CDER regulations/ICH guidelines. Understanding of pharmaceutical safety reporting and surveillance requirements. Excellent verbal and written communication skills and presentation skills. Strong interpersonal skills. Leadership skills. Desire to work within a multidisciplinary team. Computer literacy. Ability to work internationally.
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Salary: Open,
Job Type: Permanent,
Total Exp: 3+ Yrs,
Start Date: ASAP,
Location: San Francisco, CA |
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| Job ID: |
RC-04288-1 - Director Clinical Research, Infectious Diseases |
| Description: |
Job Description
You will participate in the scientific direction, planning, implementation, conduct and interpretation of clinical trials and research. Along with a multi-disciplinary project team you will oversee data collection activities and support the team with the global drug development process including interactions with health authorities and act as a spokesperson to internal and external audiences for product development.
Knowledge/Skills
M.D. ABIM board certification in infectious diseases and basic science research experience; personnel, budget, and clinical trials management experience; with 7-10 years' related experience in clinical or basic scientific research. Pharmaceutical industry experience required. HIV clinical experience preferred
Specific Education and Experience Requirements
Board certified MD with Infectious Disease experience in industry and/or research related field.
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Salary: to 230K,
Job Type: Permanent,
Total Exp: 8-12 Yrs,
Start Date: ASAP,
Location: San Francisco, CA |
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| Job ID: |
TB-03208-1 - Director of Clinical Operations |
| Description: |
Responsibilities
The selected candidate will effectively manage the activities of project managers and staff in a manner that ensures all timeframes and targets are met and that costs are kept under control; serve as a senior level liaison with clients; represent Clinical Research in Business Development (BD) activities; and provide leadership and assist as appropriate in managing the clinical research department in an effective manner.
In this role, you will effectively manage and mentor all staff; ensure all necessary training; assist the VP Regional Operations and/or the Clinical Director in overseeing department and study needs; oversee management of projects/direct projects to ensure they are conducted in an effective manner, meeting Sponsor timelines and expectations and in adherence with SOPs, appropriate regulations and Quality standards; serve as CPM, Project Director and/or Global Director for projects as assigned; and provide financial oversight to projects to ensure appropriate profitability.
Qualifications
The qualified candidate will have a BS in Science or other relevant discipline and appropriate experience and significant leadership and managerial skills. Must be able to proactively recognize study and company needs and implement an effective action plan, oversee all aspects of study management, manage project managers and interact positively with all levels of staff, liaise successfully with all levels of management, vendors, and clients. Additionally you must be able and willing to travel approx. 20% of the time (International and Domestic).
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Salary: OPEN,
Job Type: Permanent,
Total Exp: 4-5 Yrs,
Start Date: ASAP,
Location: Chicago, IL |
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| Job ID: |
PS-07076-7 - Director, Biostatistics (CNS) (EGC) |
| Description: |
*
Technical expertise and demonstrated capability in leading
statistics teams within the pharmaceutical industry
* Expertise may be technically rather than
managerially focused
* Establishing
reputation within the pharmaceutical biostatistics field
* Experience in assisting in compound
submissions together with broad understanding and experience of the
clinical development process
* Directs the
biostatistics strategy and contributes to its outcome within area of
responsibility
* Assumes accountability for
analysis for clinical trials/clinical development plans across EGC
multiple therapeutic areas and worldwide locations, potentially
having primary site responsibility
* Begins
to take an enterprise-wide perspective and influence the proper use
of statistics throughout EGC
* Interacts
with external stakeholders through daily work
* Contributes to innovation within the
biostatistics field and an active member of societies and
institutions
Qualifications
* Minimum of a Masters degree in Biostatistics
or related discipline. MD or PHD highly preferred
* At least 10 years relevant experience in the pharmaceutical industry, including line management experience |
| |
Salary: Open, Job Type: Permanent, Total Exp: 10+ Yrs,
Start Date: ASAP,
Location: Ridgefield Park, NJ |
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| Job ID: |
PC-05026-2 - Director, Clinical Research |
| Description: |
Responsibilities: Serve as Project Director for
large, complex, often global projects, As required, serve as Project
Manager for other projects, Supervise and mentor Associate
Directors, Managers, and other direct reports, May act as
administrative office head (if based in satellite office), Ensure
effective and efficient interactions between Clinical Research
personnel and personnel from other departments, Track headcount
needs and availability within group, Participate in proposal
meetings with potential clients, Review and approve Business
Development proposals, Ensure proper use of project management tools
by direct reports, Oversee hiring of new personnel within group,
Contribute to operational excellence by identifying best practices,
actively participating in Project Review sessions, and by making
recommendations to senior management
Requirements: BS/BA degree, graduate degree
preferred, 10+ years relevant industry experience; four years
project management experience, Ability and willingness to travel up
to 20% of the time, Excellent written and oral communication skills,
Demonstrated ability to lead a diverse and growing employee
population. |
| |
Salary: 110-130k, Job Type: Permanent, Total Exp: 10+ Yrs,
Start Date: ASAP,
Location: Princeton, NJ |
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| Job ID: |
TRS-02158-13 - Director, CNS |
| Description: |
Description:
The
incumbent is responsible for but not limited to the following:
- Supporting the CNS are function and strategy.
- Leading problem solving across the CNS
area with an enterprise-wide perspective: facilitating team(s) to
identify issues and propose solutions.
-
Contributing to development results by providing CNS area leadership
and assuming supervisory and/or "subject matter expert" role with
regards to therapeutic area issues.
-
Bringing external marketplace perspectives, sharing insight and
knowledge regarding therapeutic areas with groups within own
department and across Eisai, as appropriate.
- Providing technical insight to ensure
progress towards goals.
- Leading IPT or
Study Team as appropriate.
Qualifications:
- MD,
PhD or equivalent degree required, with MD preferred, with Neurology
or Psychiatry specialty certification, and significant research
background in Alzheimer Disease and or other dementias.
- At least 3-5 years additional related
experience for an MD or 7-10 years for a PhD (including academic
research).
- Significant experience in
leading clinical trials.
- Working
knowledge of other functional areas (e.g., Clinical Operations,
Regulatory, Pre-Clinical, and Marketing).
-
Experience in working with pre-clinical scientists and leading
project/study teams.
|
| |
Salary: Open, Job Type: Permanent, Total Exp: 3-10 Yrs,
Start Date: ASAP,
Location: Ridgefield Park, NJ |
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| Job ID: |
TRS-02158-17 - Director/Senior Director,
Gastroenterology |
| Description: |
Description:
Medical
knowledge & expertise or industry experience within the GI
Therapeutic Area
Accountable for goals
& objectives of a study
Participate
in advisory boards, as necessary
Contribute to development results by providing GI Therapeutic Area
leadership & assume a supervisory and/or "subject matter expert"
role with regard to GI Therapeutic Area issues
May make decisions for the GI Therapeutic
Area on an EGC-wide perspective
Qualifications:
MD
or PHD with significant therapeutic area experience required. MD
with specialty training within the therapeutic area(s) preferred
? At least 5 7 years additional related
experience for an MD or 10 15 years for a PHD (including academic
research), preferably including some broader industry experience
|
| |
Salary: Open, Job Type: Permanent, Total Exp: 5-7 Yrs,
Start Date: ASAP,
Location: Ridgefield Park, NJ |
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| Job ID: |
TRS-02158-5 - Director/Senior Director, Imaging |
| Description: |
Description:
The
incumbent is responsible for, but not limited to the following:
A. Project specific:
i. lead development (in conjunction with
clinical teams , Imaging Group and external imaging KOLs ) an
imaging biomarker strategy for PoC as well as compound profiling and
registration trial endpoints.
ii. Interface
with preclinical groups to develop possible tracers for target
imaging /dose occupancy and to coordinate translational imaging in
animal models to insure optimal bridging of imaging biomarker(s)
into the clinic.
iii. Responsible for input
into DDP/CDP regarding imaging strategies and for input to imaging
components of projects through Imaging Advisory Boards/ involving
expert imagers at project Ad Boards
B.
Study-level:
i. Design imaging component
for protocol concept sheet and full protocol (in conjunction with
clinical team with review by Imaging Group).
ii. Identify technically qualified sites and
imaging co-investigators for implementation of imaging components
(critical for more advanced types of imaging)
iii. Identify imaging CRO/academic core lab for
centralized analysis for multi-center studies, expert analysis for
single center studies.
iv. Insure proper
analysis and interpretation of imaging component data
C. General: ( Imaging Group Activities)
i. Develop templatetype language for PCSs,
protocols, CRF forms, informed consent forms for recurring types of
PET /SPECT or MRI imaging
ii. Provide
didactic information to teams on PET/SPECT and MRI imaging to
facilitate understanding of imaging components.
Qualifications:
MD and /or PhD with documented imaging
expertise ( radiology, nuclear medicine /PET physician, imaging
scientist, medical subspecialist with imaging experience ). Board
eligibility and /or certification is desirable.
Expertise in at least one imaging modality (
PET/SPECT , MRI, CT ). Experience in more than one therapeutic area
is preferred( neurology, psychiatry, oncology , arthritis,
cardiovascular). Experience in drug development ( minimum of 2
years) including early phase development and preclinical to clinical
translation is highly desirable.
Peer-reviewed publications and experience in scientific
presentations
Excellent verbal and
written communication skills
Good
interpersonal skills and ability to work in a cross-functional team
environment
15-20% travel (domestic and
international)
|
| |
Salary: Open, Job Type: Permanent, Total Exp: 5+ Yrs,
Start Date: ASAP,
Location: Ridgefield Park, NJ |
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| Job ID: |
TRS-02158-14 - Director/Senior Director,
Oncology |
| Description: |
Description:
The
incumbent is responsible for, but not limited to the following:
Assuming (Global) leadership for one or more
Oncology area programs
? Defining
Oncology/project vision and strategy for achieving that vision, and
engaging and motivating teams to buy into that vision and execute
strategy through clear and persuasive communication skills
?? Providing technical insight to ensure
progress towards goals
?? Contributing
innovative thinking and brings an external market perspective to
task within and outside area of direct accountability
Motivating exceptional performance
Acting as an informal mentor and coach for
team members
Qualifications:
? MD
with specialty training in Oncology
? At
least 5-7 years additional related experience including industry
experience
Medical and technical
development expertise in tandem with strong working knowledge of
other functional areas (e.g., clinical operations, regulatory,
pre-clinical and marketing)
? Sound
knowledge of regulatory process on a global basis. Experience with
regulatory filing highly desirable
?
Established reputation within the Oncology area
Expertise in managing groups preferably
across geographic regions
|
| |
Salary: Open, Job Type: Permanent, Total Exp: 5-7 Yrs,
Start Date: ASAP,
Location: Ridgefield Park, NJ |
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| Job ID: |
DS-01108-2 - Manager, Clinical Projects |
| Description: |
This is a biopharmaceutical company dedicated
to developing breakthrough biologic medicines in the area of
oncology. The Company has utilized the many advances made in the
fields of molecular biology, oncology, genomics, and antibody
engineering to build a novel pipeline of product candidates designed
to address specific genetic mechanisms involved in cancer growth and
development.
Their goal is to become a
fully-integrated biopharmaceutical company that has the capability
and resources to take its novel pipeline compounds and develop them
from the research and development stage through to commercial
manufacture, marketing and sales. With their first innovative cancer
drug on the market and late stage clinical candidates soon to be,
they have cooperative agreements with several big pharmaceutical
companies to help market their drugs. A solid, fast growing midsized
company which incorporates the best of both worlds, security with
room to grow.
Currently looking for a
Manager, Clinical Projects.
Summary/Essential Duties &
Responsibilities:
GENERAL SUMMARY
Under minimal
supervision, manages the conduct of one or more clinical
investigations. Performs assigned responsibilities to assure timely
completion of departmental goals and objectives. Prepares and
reviews management reports, ad hoc reports, summaries, analyses on
clinical databases. Coordinates and participates in co-monitoring of
these investigations. Assists with special projects as assigned.
ESSENTIAL DUTIES AND
RESPONSIBILITIES
Every effort has been made to identify the
essential functions of this position. However, it in no way states
or implies that these are the only duties you will be required to
perform, nor is it intended to be such a listing of the skills and
abilities required to do the job. The omission of specific
statements of duties does not exclude them from the position if the
work is similar, related, or is an essential function of the
position.
1.
Manages the conduct of assigned clinical investigations and
activities associated with it.
2. Manages
the interaction of appropriate departments to support and maintain
the clinical investigation(s).
3. Assists
with the management of the co-monitoring of assigned clinical
investigations.
4. Oversees the Quality
Control review of clinical trial patient databases
5. Supervises CRO training programs to assure
consistency and compliance in monitoring of clinical
investigations.
6. Coordinates and
participates in the co-monitoring of assigned clinical
investigations as needed.
7. Prepares and
distributes monthly management reports, ad hoc reports, summaries,
or analyses. Prepares status reports for assigned clinical
investigations.
8. Prepares drug usage
projections and tracking for assigned clinical investigations.
9. Participates in the periodic review and
revision of department policies and standard operating procedures
(SOPs) to assure compliance with corporate policies, good clinical
practice (GCP) procedures, or regulations of governmental
agencies.
10. Contributes to the selection
process of new hires, including reviewing candidates credentials,
interviewing candidates, and making hiring recommendations.
11. Assists with preparation and execution of
Investigator meetings
12. Prepares
department budgets, timelines, and project plans.
13. Maintains professional skills by keeping
abreast of literature, attending conferences, courses, and
meetings.
14. Maintains knowledge of U.S.
and foreign regulations, guidelines, policies and practices for
conducting clinical investigations.
15.
Follows departmental policies, procedures, and SOPs.
Essential Knowledge, Skill, Experience:
1. Five to ten years of progressively
increasing clinical research experience within the pharmaceutical
industry.
2. Experience in drug development,
especially Food and Drug Administrations regulations and Good
Clinical Practices or Associates of Clinical Pharmacology CRA
certification.
3. Experience in IND/NDA/BLA
submissions
4. A minimum academic degree in
Nursing (R.N. or B.S.N.), Life Sciences (B.S. or B.A.), Pharmacy or
Medicine. Experience requirements may be less with advanced
degrees.
5. Ability to resolve and make
judgments regarding administrative, scientific and/or clinical
problems with minimal supervision.
6.
Ability to deliver oral presentations and write in a clear, focused,
and concise manner
|
| |
Salary: 100k, Job Type: Permanent, Total Exp: 3-5 Yrs,
Start Date: ASAP,
Location: Branchburg, NJ |
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| Job ID: |
DS-01108-4 - Manager, Clinical Projects |
| Description: |
This is a biopharmaceutical company dedicated
to developing breakthrough biologic medicines in the area of
oncology. The Company has utilized the many advances made in the
fields of molecular biology, oncology, genomics, and antibody
engineering to build a novel pipeline of product candidates designed
to address specific genetic mechanisms involved in cancer growth and
development.
Their goal is to become a
fully-integrated biopharmaceutical company that has the capability
and resources to take its novel pipeline compounds and develop them
from the research and development stage through to commercial
manufacture, marketing and sales. With their first innovative cancer
drug on the market and late stage clinical candidates soon to be,
they have cooperative agreements with several big pharmaceutical
companies to help market their drugs. A solid, fast growing midsized
company which incorporates the best of both worlds, security with
room to grow.
Currently looking for a
Manager, Clinical Projects.
Summary/Essential Duties &
Responsibilities:
GENERAL SUMMARY
Under minimal
supervision, manages the conduct of one or more clinical
investigations. Performs assigned responsibilities to assure timely
completion of departmental goals and objectives. Prepares and
reviews management reports, ad hoc reports, summaries, analyses on
clinical databases. Coordinates and participates in co-monitoring of
these investigations. Assists with special projects as assigned.
ESSENTIAL DUTIES AND
RESPONSIBILITIES
Every effort has been made to identify the
essential functions of this position. However, it in no way states
or implies that these are the only duties you will be required to
perform, nor is it intended to be such a listing of the skills and
abilities required to do the job. The omission of specific
statements of duties does not exclude them from the position if the
work is similar, related, or is an essential function of the
position.
1.
Manages the conduct of assigned clinical investigations and
activities associated with it.
2. Manages
the interaction of appropriate departments to support and maintain
the clinical investigation(s).
3. Assists
with the management of the co-monitoring of assigned clinical
investigations.
4. Oversees the Quality
Control review of clinical trial patient databases
5. Supervises CRO training programs to assure
consistency and compliance in monitoring of clinical
investigations.
6. Coordinates and
participates in the co-monitoring of assigned clinical
investigations as needed.
7. Prepares and
distributes monthly management reports, ad hoc reports, summaries,
or analyses. Prepares status reports for assigned clinical
investigations.
8. Prepares drug usage
projections and tracking for assigned clinical investigations.
9. Participates in the periodic review and
revision of department policies and standard operating procedures
(SOPs) to assure compliance with corporate policies, good clinical
practice (GCP) procedures, or regulations of governmental
agencies.
10. Contributes to the selection
process of new hires, including reviewing candidates credentials,
interviewing candidates, and making hiring recommendations.
11. Assists with preparation and execution of
Investigator meetings
12. Prepares
department budgets, timelines, and project plans.
13. Maintains professional skills by keeping
abreast of literature, attending conferences, courses, and
meetings.
14. Maintains knowledge of U.S.
and foreign regulations, guidelines, policies and practices for
conducting clinical investigations.
15.
Follows departmental policies, procedures, and SOPs.
Essential Knowledge,
Skill, Experience:
1. Five to ten years of
progressively increasing clinical research experience within the
pharmaceutical industry.
2. Experience in
drug development, especially Food and Drug Administrations
regulations and Good Clinical Practices or Associates of Clinical
Pharmacology CRA certification.
3.
Experience in IND/NDA/BLA submissions
4. A
minimum academic degree in Nursing (R.N. or B.S.N.), Life Sciences
(B.S. or B.A.), Pharmacy or Medicine. Experience requirements may be
less with advanced degrees.
5. Ability to
resolve and make judgments regarding administrative, scientific
and/or clinical problems with minimal supervision.
6. Ability to deliver oral presentations and
write in a clear, focused, and concise manner
|
| |
Salary: 100k, Job Type: Permanent, Total Exp: 5-10 Yra,
Start Date: ASAP,
Location: Branchburg, NJ |
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| Job ID: |
PC-07186-3 - Manager, Clinical Research |
| Description: |
Job Description
Manage
interdisciplinary clinical research projects; Lead the clinical team
to ensure on-time, on-budget performance; Approve investigator study
budgets and contracts
Supervise, train and
mentor clinical research staff; Review and develop protocols and
Case Report Forms (CRFs); Plan, coordinate, and present at
investigators' meetings; Participate in proposal meetings with
potential clients
Review Serious Adverse
Event (SAE) reports; Review and approve monthly client invoices;
Prepare project management reports; Review and approve monitoring
trip reports
Train and mentor CRAs on
position responsibilities
Requirements
BS/BA
degree or RN
Strong Oncology experience required
For those with BS/BA,
s ix years minimum experience in clinical research, data management,
or regulatory affairs, with at least two years experience in the
monitoring and management of clinical research projects
IF RN (in lieu of BS/BA) must have total of
eight years of relevant experience
Ability
and willingness to travel up to 20% of the time; Excellent written
and oral communication skills |
| |
Salary: 80-100k, Job Type: Permanent, Total Exp: 8 Yrs,
Start Date: ASAP,
Location: Princeton, NJ; Blue Bell PA |
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| Job ID: |
PS-07076-1 - Manager/ Sr Manager, Clinical Operations,
CNS |
| Description: |
Technical (and
possibly management) capabilities to lead large or multiple clinical
studies from protocol development to final analysis and submission
within a therapeutic or compound area Knowledge of a number of areas
in the drug development process, including clinical plan
development, study areas and execution of the clinical study chain
and of the therapeutic area Manages multiple resources within and
across clinical operations groups to meet deliverables Leads and
facilitates team meetings by providing guidance to team members by
structuring approaches and adding insight to facilitate task
execution
Qualifications:
Minimum
of a Bachelors of Science degree in a relevant scientific
discipline
5+ years experience in
pharmaceutical industry, including managing
outsourcing to CROs. Line management experience
highly preferred
|
| |
Salary: $95k-$125K, Job Type: Permanent, Total Exp: 5+ yrs,
Start Date: ASAP,
Location: Ridgefield Park, NJ |
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| Job ID: |
PS-07076-8 - Process Validation Scientist |
| Description: |
Bonus/Incentives: Yes
Relocation: Yes
Dress:
Business Casual.
Is travel required: No
Primary Responsibilities: This individual will
participate in and may lead activities to develop manufacturing
processes and troubleshoot existing processes and production
scale-up batches for solid dosage forms in support of Process
Development. Strive to raise awareness to the importance of
"first-time quality" at development, technical support, and
validation levels to eliminate the broad negative impact on
effectiveness, costs, and quality down line. Organize and carry out
designated day-to-day project operations in support of high quality
product development/ scale up and technical support and efficient
cost effective Process Development Operations. Ensure compliance
with current Drug Enforcement Administration (DEA), Good
Manufacturing Practices (cGMP), the companies policies, and all
applicable regulatory agencies. Participate in decision-making and
achievement of business goals by demonstrating depth and breadth of
technical knowledge and good communication skills in
across-functional environments.
Software
Experience Required: MSWord, Excel, PowerPoint
Degree Type: BA/BS
Major: Pharmacy, Chem Engineering or related
science
Yrs Experience: (5) FIVE
Experience Preferred: Requires a minimum of a
B.S. in Pharmacy, Chemical Engineering or related science. This
experience includes demonstrated expertise in the field of
pharmaceutical processes, process development, scale-up and
validation of solid dosage processes. Excellent communication skills
(oral and written) a plus.
|
| |
Salary: $60K-$70k, Job Type: Permanent, Total Exp: 5 years,
Start Date: ASAP,
Location: Davie, Fl |
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| Job ID: |
PC-07186-15 - Project Associate I/II |
| Description: |
Job Description- Project Associate I
Monitor investigator
sites for GCP compliance (20 - 25% travel); Obtain and review
regulatory and administrative documents from Investigator sites and
recruit Investigators for participation in clinical trials
Generate and resolve
queries from clinical data; work with study site personnel to ensure
completeness and accuracy of CRFs and other clinical data
Requirements
BA/BS or RN
Six months' work
experience in clinical research
6 months of on-site monitoring experience
required
Position
focuses heavily on in-house review of reg docs
Ability and
willingness to travel up to 25% of the time
Job Description- PA
II
Monitor
investigator sites for GCP compliance (20 - 25% travel); Obtain and
review regulatory and administrative documents from Investigator
sites and recruit Investigators for participation in clinical
trials
Generate and
resolve queries from clinical data; work with study site personnel
to ensure completeness and accuracy of CRFs and other clinical
data
Mentor and
train junior clinical Project Associates on monitoring, query
resolution and other position related responsibilities
Requirements
BA/BS or RN
Two years' work
experience in the field monitoring of clinical trials
Ability and
willingness to travel up to 25% of the time
|
| |
Salary: Open, Job Type: Permanent, Total Exp: 1+ years,
Location: Princeton, NJ,
Blue Bell,RTP,San Diego, Boston |
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| Job ID: |
TRS-02158-12 - Senior Clinical Research Scientist,
CNS |
| Description: |
Description:
The
incumbent is responsible for, but not limited to the following:
Assisting the Clinical Leader in the
planning, implementation, managing, and reporting of clinical trials
but may serve as Clinical Leader for selected trials.
Preparing clinical trial Synopses and
clinical trial Protocols. Prepares patient SAE narratives, section
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