| Job List |
| 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: |
LP-05028-2 - Clinical Project Manager |
| Description: |
Responsibilities:
Manage the investigative sites by discussing and resolving protocol, budget, enrollment and staffing issues.
Ensure that project status information is collected and distributed to the Luitpold team.
Direct and interact with the Clinical Research Associates (CRAs) and Project Coordinator to ensure that the project is properly monitored, and data is accurate and collected uniformly between the various investigative sites.
Direct outside vendors including consultants and CROs with respect to the clinical trials.
Prepare and review protocols, reports, and other study information.
Prepare and review SOPs and ensure that procedures are appropriately and consistently applied to all study activities.
Responsible for the successful completion and regulatory rigor of all clinical studies.
Responsible to the timely completion of all clinical studies.
Responsible for adequate training of clinical staff.
Other responsibilities include: Investigator Payments, Study Tracking, and Study Files.
Overnight travel required.
Requirements:
Clinical degree.
Minimum of 5 years Project Management of Oncology studies.
Ability to manage timelines, budgets and CRAs and outside vendors.
Previous experience as a CRA.
MS Word, Excel, Medical/Regulatory Terminology.
Excellent communication skills (oral and written) a must.
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Salary: 100-110k,
Job Type: Permanent,Contract,
Total Exp: 5 Yrs,
Start Date: ASAP,
Location: Philadelphia Area |
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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: |
LP-05028-1 - CRA |
| Description: |
RESPONSIBILITIES:
- Assist with Administration of clinical research projects: recruiting investigators, collecting investigator documentation, site management, "clinical contact," and preparing status reports.
- Initiate, monitor and close-out clinical investigative sites under supervision from Project Managers and Project Directors.
- Provide ongoing assistance and education of investigational sites in clinical research.
- Update, track and maintain study specific trial management tools/system.
- Monitor Case Report Forms (CRF) for missing implausible data. Assist sites with maintaining Good Clinical Practices (GCP).
- May report, write narratives and follow-up on reported serious adverse experiences.
- Assist with generation and reconciliation of queries to investigation sites to resolve problem data.
- Assist and manage project budget and investigator site budget, attend and project team meetings, plan and attend investigator meetings, and communicate with clients.
- Generate and track drug shipments and storage.
- Provide coverage to clinical contact telephone lines.
- Travel as necessary, consistent with project needs.
Job Requirements:
BS degree in Clinical or Biological Science.
1 - 2 years experience in Drug Development, Regulatory Affairs.
Previous CRA experience.
50% travel required.
MS Word, Excel, Medical/Regulatory Terminology.
Outstanding communication skills.
Dialysis, rheumatology, oncology, cardiology or GI experience preferred. |
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Salary: OPEN,
Job Type: Permanent,Contract,
Total Exp: 2+ yrs,
Start Date: ASAP,
Location: Philadelphia Area |
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| Job ID: |
PN-11307-1 - CRA I/II |
| Description: |
Our client, a growing CRO is looking for individuals with experience monitoring oncology studies. Several positions exist, depending upon your experience and situation.
This is a CRO that cares for and rewards their clinical monitoring talent. Some of the extras they provide their CRAs include:
One airline club memberships to all CRAs who travel
Focus on limited number of Protocols (typically 2-3)
Light-weight laptops
Excellent time management system and superior connectivity
Excellent career path opportunities (PM) whether office or home-office based
Experienced management team. Regional CRAs have dedicated line managers
Team environment, including annual meetings
Company pays for 1 professional membership/year i.e. SOCRA, ACRP
Reimbursement for professional exams and certifications
Quick turnaround on expense reimbursement
Car Allowance for certain levels
Position can be office based (San Diego, CA) or home-based (must reside within the Pacific Time Zone: e.g. CA, AZ, NV, or Canada.)
CRA I/II:
Responsibilities: On-site monitoring, protocol/CRF development, investigator recruitment, in-house review of clinical data, generation of project-management reports, and assisting in the preparation of clinical study reports. Travel will average 50%.
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Salary: Open,
Job Type: Permanent,
Total Exp: 2+ Years,
Location: Westcoast |
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| Job ID: |
HDS-11207-1 - Director of Research and Development (DRD) |
| Description: |
The Director of Research and Development (DRD) will be in charge of the Companys the research and development facilities, laboratory personnel, and other scientific activities. He will report to the Chief Executive Officer on product development, assay development and validation, and other areas.
The DRD will support the manufacturing and quality control personnel in Miami and Panama. He will significantly impact the Companys scientific efforts, including but not limited to R&D laboratory operations; he will be responsible for designing lab projects, developing prioritization schedules and assigning them to existing lab technicians. Performance will be measured on timely results and ability to interact with other key personnel. Therefore, he needs to be a hands-on manager who will do the actual work alongside his staff every day.
The DRD should have an advanced degree in a related field with a background in industry (medical diagnostic products or pharmaceutical). Experience with lateral flow immunochromatography and ELISAs is essential. Experience working with FDA or ISO facilities is also important.
The DRD must be an independent thinker, well-versed in scientific literature, an excellent oral communicator with appropriate writing skills. It would help but is not essential to be bi-lingual in Spanish.
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Salary: OPEN,
Job Type: Permanent,
Total Exp: 6+ Yrs,
Start Date: ASAP,
Location: Miramar, FL |
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| Job ID: |
IN-09127-1 - Medical Writer |
| Description: |
Due to company growth, and a steadily increasing flow of regulatory documents into the clinical group, we are looking to fill a newly-created position within our Research & Development Department. This is a great opportunity for the right individual.
This is a full-time, direct hire, exempt position, and the job description is attached. The salary range is $60K to $65K, and we offer a bonus target potential of 10 percent of annual base salary.
The work hours are 8:30 AM to 5:00 PM, Monday through Friday.
In addition to salary and annual bonus, this company offers a comprehensive package of benefits including medical, dental, vision, paid life insurance and paid Long-term Disability.
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Salary: 60-65k,
Job Type: Permanent,
Total Exp: 3 Yrs,
Start Date: ASAP,
Location: Clinton, NJ |
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| Job ID: |
RG-11267-4 - Medical Writer |
| Description: |
Job Description:
Responsible for the writing and/or editing of a variety of scientific and medical documents and ensuring that they adhere to regulatory guidelines and departmental editorial standards. Documents include but are not limited to:
- protocols (clinical protocols (Phases I-III; IV), write clinical study outlines and protocols and draft documents in collaboration with
study team. Ensure protocol meets all regulatory and stylistic guidelines, contain an appropriate statistical analysis plan and will provide data needed for writing the CSR and scientific publications
- case reports forms,
- data tables, data listings, and data figures; ensure that statistics are presented accurately; prepare appropriate in-text tables to present data
- developing final study reports (Write clinical study reports (CSRs) for phase I; II; III; IV studies) Responsible for filing of completed CSR and appendices in repository;
- patient synopses
- investigators' brochures
- new drug applications (NDA)
- investigational new drug (IND) applications Maintain document standardization with the use of model documents/templates in order to ensure the quality of clinical project documentation
-Responsible for the QC of documents written by other authors. Responsible for proof reading own documents for consistency and compliance with internal and external guidance documents.
-Responsible for the importation of report appendix documents into a document management system. Confirms communications by obtaining required internal and external reviews; incorporating reviewer comments; proofing, editing, and revising copy; completing quality assurance checks, including case report forms (CRF) vs. protocols, statistical analysis plans (SAP) vs. protocol/annotated CFRs, data management plans (DMP) vs. protocol/annotated CFRs, case report tabulations (CRT)/listings vs. statistical analysis tables, clinical study report write-ups vs. statistical analyses and CRT/listings; obtaining final signoffs.
-Prepare clinical development plans and other clinical documentation as required Collaborate with counterparts to ensure timely preparation of publication plans and write abstracts, manuscripts and other materials as needed.
-Updates job knowledge by tracking changes in writing guidelines; participating in educational opportunities; reading professional publications; maintaining personal networks. Enhances organization reputation by accepting ownership for accomplishing new and different requests; exploring opportunities to add value to job accomplishments
Relocation Plan Available. |
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Salary: to 85k,
Job Type: Permanent,
Total Exp: 2+ Yrs,
Start Date: ASAP,
Location: Tarrytown, NY |
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| Job ID: |
HR-09217-1 - RA/QA Advanced Engineer |
| Description: |
JOB SUMMARY: This role has RA/QA responsibility throughout the enterprise (Marketing, Sales/Service, Supplier, R&D, Manufacturing and Customer).
ESSENTIAL DUTIES AND RESPONSIBILITIES Other duties may be assigned:
Serves as a primary point of contact for all quality & regulatory related matters.
Serves as product development core-team member.
Facilitates worldwide product registration and ensures post-market compliance.
Has primary responsibility for product verification and validation compliance.
Identifies, qualifies, audits and monitors supplier and internal quality performance.
Ensures appropriate controls (key metrics) are defined, implemented and satisfactorily completed for all product development, manufacturing and distribution operations.
Drives data analysis of quality performance to identify high priority issues relating to safety, complaints and systemic customer satisfaction.
Ensures GCP compliance, supplies good clinical research and marketing support, and reviews/approves labeling, including advertisement and promotional literature.
Provides training to ensure proper implementation and use of quality tools and procedures as required.
Enables rapid and effective correction of quality/regulatory problems in a manner that prevents their reoccurrence.
SUPERVISORY RESPONSIBILITIES:
May be responsible for directing the work efforts of QA/RA engineers and/or technicians.
QUALIFICATIONS:
Working knowledge of regulatory affairs (Pre-Market, Post Market, GXP)
Proven ability to resolve Marketing, Sales/Service, Supplier, Manufacturing, R&D & Customer issues
Quality/Regulatory Experience
Software development experience a plus, awareness a must.
Proficient with QSR, Medical Device Directive, GCP and ISO Quality System Standards
Excellent analytical decision making and problem solving skills
Track record of business and customer orientation
EDUCATION AND/OR EXPERIENCE:
B.S. in Engineering or Science accompanied with 2-6 years of QA/RA experience and/or B.S. in non-technical field accompanied with 6 years of QA/RA experience
CQA, CQE or RAC desired
Experience in a medical device or other FDA regulated industry required
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Salary: Open,
Job Type: Permanent,
Total Exp: 2-6 Yrs,
Start Date: ASAP,
Location: RTP, NC |
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| Job ID: |
CIR-01168-1 - Regional CRA |
| Description: |
The Regional CRA manages the implementation of study protocols at research sites. Responsibilities include but are not limited to: serving as a CRA for clinical studies; performing monitoring visits including site qualification, initiation, monitoring and closeout visits; developing monitoring plan; maintaining contact with study sites, report preparation and communications documentation; conducting training; preparing for and participating in Sponsor and FDA audits; managing clinical project assistants and associates.
Required qualifications: BA/BS degree or equivalent combination of education and experience in a medical or scientific discipline; minimum 1 year regional monitoring experience; significant technical, medical or industry experience in a clinical research setting; strong understanding of Medical Terminology, Physiology, and Pathophysiology; working knowledge of Good Clinical Practices; strong organizational skills; the ability to multi-task and work effectively in a fast-paced environment; strong written and verbal communication and diplomacy skills; professional demeanor and appearance; ability to travel.
Preferred qualifications: BS in scientific discipline; 2+ years experience in a CRO.
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Salary: OPEN,
Job Type: Permanent,
Total Exp: 2-4 Yrs,
Location: Most USA locations |
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| Job ID: |
RG-11267-1 - Regulatory Associate IV |
| Description: |
Job Description:
This position in Regulatory Affairs:
-involves the ability to integrate/apply knowledge of global regulations governing pharmaceutical drug development to all aspects of the company's preclinical and clinical drug development programs.
-provides guidance to multidiscplinary teams on the content, format, style of Regulatory submissions to Regulatory authorities.
-edits scientific sections of submission to comply with regulatory requirements.
-assists with the writing, review and preparation of IND applications amendments, annual reports and other regulatory documents and correspondence.
Strong organizational and negotiation skills, excellent written and verbal communication skills and an advanced proficiency in Microsoft Office and desktop publishing applications are necessary.
A minimum of a bachelor's degree in a scientific discipline, biomedical, engineering, or related area is required. Previous experience in pharmaceutical development with biotechnology products is highly desirable. RAC certification by the Regulatory Affairs Professional Society is desirable. The successful candidate must have three to five years of experience conducting regulatory activities. Previous global Regulatory experience, NDA or BLA experience, and electronic submission expertise are preferred. |
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Salary: to 95k,
Job Type: Permanent,
Total Exp: 2+ Yrs,
Start Date: ASAP,
Location: Tarrytown, NY |
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| Job ID: |
RG-11267-5 - Senior Medical Safety Associate |
| Description: |
The successful candidate will have demonstrated capabilities and sufficient training and experience to oversee and implement a patient safety registry and the collection, recording, and organization of post marketing adverse experiences for an orphan drug. He or she will receive this information rom an experienced call center group. She or he will work closely with the Senior Director Medical Safety and the Chief Medical Safety Officer to organize and interpret these safety data. Appropriate follow-up with the patient and/or the patient?s physician will be required.
He or she will also be responsible for the creation of required regulatory communications, generating periodic report listings, and summarizing the safety experience on a periodic basis. The candidate should be able to devise and follow appropriate operating procedures to conduct this effort in a manner consistent with Good Clinical Practice. She or he will conduct periodic literature reviews of the safety of the subject drug(s) to include ith the periodic reports.
Additional responsibilities may include gaining experience with the organization and interpretation of safety data from clinical trials and ollection and interpretation of serious adverse experiences.
Relocation Plan Available. |
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Salary: to 110k,
Job Type: Permanent,
Total Exp: 4+ Yrs,
Start Date: ASAP,
Location: Tarrytown, NY |
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| Job ID: |
PN-11307-2 - Sr CRA West Coast Regional |
| Description: |
Our client, a growing CRO is looking for individuals with experience monitoring oncology studies. Several positions exist, depending upon your experience and situation.
This is a CRO that cares for and rewards their clinical monitoring talent. Some of the extras they provide their CRAs include:
One airline club memberships to all CRAs who travel
Focus on limited number of Protocols (typically 2-3)
Light-weight laptops
Excellent time management system and superior connectivity
Excellent career path opportunities (PM) whether office or home-office based
Experienced management team. Regional CRAs have dedicated line managers
Team environment, including annual meetings
Company pays for 1 professional membership/year i.e. SOCRA, ACRP
Reimbursement for professional exams and certifications
Quick turnaround on expense reimbursement
Car Allowance for certain levels
Position can be office based (San Diego, CA) or home-based (must reside within the Pacific Time Zone: e.g. CA, AZ, NV, or Canada.)
Senior CRA:
Responsibilities: Assist in managing large-scale clinical trial projects or function as project manager for small-scale projects, ensuring on-time, on-budget performance, on site monitoring of clinical trials (average of 30% travel), Protocol/CRF development; investigator recruitment; in-house review of clinical data; generation of project management reports; and assisting in the preparation of clinical study reports. Travel will average 50% - 60%.
Regional CRA
Responsibilities: Monitor Investigator sites for GCP/ICH compliance, Investigator recruitment, site selection, collect and review clinical data. Regional CRAs travel up to 80% - Travel is primarily regional with day/overnight trips. No coast-to-coast travel!
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Salary: Open,
Job Type: Permanent,
Total Exp: 2+ Years,
Location: Westcoast |
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| Job ID: |
RG-11267-3 - Sr. CRA/Clinical Trial Manager |
| Description: |
Job Description:
Summary: Coordinates and implements clinical research projects and is involved with writing protocols and identifying, qualifying, and training clinical sites to conduct clinical trials. Oversees the collection of data to ensure compliance with
protocol and the clinical research project bjectives as well as FDA / ICH / GCP regulations and guidelines. Must be able to travel to field sites to assist with clinical studies. Essential Duties and Responsibilities include, but are not limited to
the following:
-Interacts regularly with CRO, central laboratory, and IVRS systems.
-Follows established clinical study standards and procedures to plan and conduct clinical research studies.
-Assists with/and/or may play a lead role in the development of procedures and tools for data collection.
-Work is assigned through general instructions given for routine work; more detailed instruction is provided for new projects.
-Applies knowledge of company policies and standard practices to resolve problems.
-Analyzes issues and uses judgment to make decisions.
-Escalates non-standard problems or issues as may be required.
-Compiles and maintains regular status reports of study progress.
-Assists with and/or may play a lead role in the development of study documents including protocols, informed consent forms, and procedure manuals.
-Maintains open communication channels with study sites and members of the study team.
Knowledge and Specialized Skills:
-Analytical problem solving experience.
-Working knowledge of the clinical research process and regulations/guidelines.
-Can effectively communicate in large or small group settings.
-Understands current and possible future business trends and information.
-Clinical Research knowledge is essential.
-Can effectively write so needed messages are clear and understood.
Education and Experience: A Bachelor's degree (BS) from an accredited college or university plus four (4) or more years of industry related experience is required. A Master's degree (MS) and two (2)or more years of experience is also accepted. Some
Sr. CRA/Clinical Study Manager positions may require additional training within the healthcare field.
Therapeutic areas: oncology, opthamology, and inflammatory diseases.
Travel: to 25% Relocation Plan available. |
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Salary: to 100k,
Job Type: Permanent,
Total Exp: 4-5 Yrs,
Start Date: ASAP,
Location: Tarrytown, NY |
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| Job ID: |
RG-11267-6 - Tactical Project Leader - Oncology |
| Description: |
ONCOLOGY TACTICAL PROJECT LEADER ROLE AND RESPONSIBILITIES
Functions as the leader for all studies in Oncology (in charge of driving activities, manages within a matrix organization all study team members)
-Has all operational expertise and effectively represents operational needs to ensure goals are met
-Manages study teams in the Oncology program. Responsible for overall direction of clinical trials activities, including design, planning and
implementation
-Working with Regulatory Affairs, oversees activities in the planning, preparation, coordination and submission of IND packages and in responding to FDA queries, ensure timely preparation of scientifically valid submissions
-Facilitates decision making to ensure milestones are met on time. Maintains decisions once made and ensure all decisions are channeled through him/ her before getting to the team for reality check
-Is the point person for information on status of different projects in program. Provides operational data such as budgeting and resources needs, as well as project status (e.g., monitoring spending/progress) etc.
-Presents and gets approval to budgets
-Gets additional resources for the team
-Assists in preparing scenarios for potential new developments in oncology program. Has the ability to thrive in a balanced environment of commercial imperative, clinical professionalism, scientific rigor and medical ethics
-Manages drug candidate programs from lead clinical candidate selection through clinical development. Provides operational data such as
budgeting, monitoring spending/progress, administration program meetings, etc.
Requirements:
- Needs to be able to manage through a matrix organization
-Thorough working knowledge and significant experience of clinical trial design and development in relevant therapeutic areas (oncology)
-Thorough working knowledge of all aspects of GCP and the regulatory/ethical framework pertaining to clinical trials
-The knowledge, experience and ability to plan, set and manage clinical trial budgets
-Experience in one or more therapeutic areas - Oncology, CNS or Metabolism
-Assists and coaches study team members in CRO negotiations, budget preparation, timelines evaluation, scenarios evaluations with adequate
resources, training to study team members needed
-Together with solid understanding of overall drug development and thorough knowledge of specific areas of drug development. Has the
ability to work within a team in an open, frank and professional manner, building good working relationships with colleagues and peers
-First class communication skills
-Good IT skills in Word, Excel, PowerPoint are essential
Experience:
-10 years of experience in drug development in the biotechnology or pharmaceutical industries, particularly in anticancer drug development
-An advanced science degree (Biomedical, Pharmacy, Chemistry, etc.), MBA or Doctorate and substantial Healthcare industry experiences
-Proven track record as Project Leader ideally with Oncology drug development experience, but other therapeutic areas considered
-Proven record of successful management of multiple projects and be able to demonstrate effective communications and negotiation skills for a wide variety of audiences, including senior management
Relocation Plan Available. |
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Salary: to 150K,
Job Type: Permanent,
Total Exp: 10+ Yrs,
Start Date: ASAP,
Location: Tarrytown, NY |
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