| Job List |
| Job ID: |
DS-03268-1 - Sr. Clinical Project Manager |
| Description: |
This Company develops and markets advanced medical devices that help healthcare professionals treat patients more effectively. For the last 150 years, this Company has developed advanced medical devices for healthcare professionals around the world.
This company is currently looking for a Sr. Clinical Project Manager
Job Description
You will be responsible for the management of regulated and scientific clinical trials and will be expected to:
(a) Develop clear measurable project timelines with milestones,
(b) Manage contract negotiations with sites and other study business partners, (c) Develop and manage study budgets
(d) Review/prepare FDA trial submissions,
(e) Develop protocols,
(f) Interact with site Investigators and staff, and
(g) Implement and oversee all aspects of study management.
You must have the ability to form and motivate cross functional groups in order to accomplish project related objectives. You will work with management and staff in all areas. Medical device experience a plus.
Travel both domestic and international required 30% of the time.
Candidate Must Have :
- Bachelors degree with a major in life sciences, nursing, medical technology or related area. (Masters preferred)
- Minimum of five (5) years clinical affairs or related experience plus two (2) years of prior healthcare. Four (4) years of experience required with a Masters degree
- Extensive knowledge of FDA and IDE
Relocation is allowed and will be discussed during the interview process
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Salary: OPEN,
Job Type: Permanent,
Total Exp: 5 Yrs,
Start Date: ASAP,
Location: Memphis, TN |
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| 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: |
TRS-02158-7 - Associate Director, Postmarketing Regulatory Affairs |
| Description: |
Description:
The incumbent will be responsible for, but not limited to the following:
Providing regulatory input into strategic marketing initiatives and ESI policies regarding advertising and promotional activities
Reviewing and approval of all advertising and promotional materials for assigned products to insure that they comply with FDA regulations
Developmenting, implementating and the maintaining of regulatory procedures regarding review of advertising and promotional materials for marketed products
Acting as regulatory liaison with co-promote partners regarding promotional review
Acting as DDMAC liaison for assigned marketed products to facilitate FDA review
Overseeing overall regulatory labeling function for marketed products
o Supervising of Regulatory Coordinator for Labeling
o Coordinating with package engineering group for labeling review and approval
o Creating and maintaining all labeling files, including labeling history, current labeling, and change control.
o Assuring utilization of most current labeling in marketing materials
Qualifications:
Minimum BS degree or higher in life science
Five years pharmaceutical regulatory experience
At least 2 years experience reviewing advertising and promotional materials for prescription drugs or biologics
2 to 5 years of US prescription drug labeling experience, including FDA labeling negotiations and Core Data Sheets (as they translate to local labeling)
Knowledge of FDA regulations and guidance documents regarding advertising/ promotion and labeling requirements
Good knowledge of MS Office applications (MS Word, Excel, PowerPoint)
Must be very detail oriented
Must be able to work in a team environment
Must be able to function under tight timelines |
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Salary: Open,
Job Type: Permanent,
Total Exp: 2-5 Yrs,
Start Date: ASAP,
Location: Woodcliff Lake, NJ |
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| Job ID: |
TRS-02158-9 - Associate Director, Regulatory Affairs - Sepsis/GI |
| Description: |
Description:
Develop, implement & execute regulatory strategic plans & best practice departmental procedures for the GI and Sepsis group
Provide regulatory guidance for top-level project development/core teams
Responsible for managing complex regulatory submissions & communicating regulatory issues to functional areas & transmitting regulatory concerns from functional areas to Sr. Management
Actively liaise with FDA & regulatory authorities to provide/solicit guidance & support for complex submissions
Research & develop regulatory intelligence concerning competitor products
Staff training/management & self-development: supervise Regulatory Managers & Associates providing guidance, training & development to staff members/teams
Qualifications:
BS in scientific discipline required (Life Sciences, Chemistry, Toxicology or Pharmacology) required, Advanced degree preferred
5-8 years pharmaceutical experience, at least 4 of which in the regulatory environment
Experience managing mulitple complex submissions & leading FDA or regulatory agency meetings preferred
Comprehensive knowledge of FDA rules, regulations & guidelines & their application in clinical research & development is essential
Experience in managing relationships and interfacing with regulatory bodies as an articulate communicator with strong negotiation skills a plus
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Salary: Open,
Job Type: Permanent,
Total Exp: 5-8 Yrs,
Start Date: ASAP,
Location: Ridgefield Park, NJ |
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| Job ID: |
TRS-02158-8 - Associate Director, Regulatory Affairs,
CNS |
| Description: |
Description:
The
incumbent is responsible for but not limited to the following:
Develop, implement and execute regulatory
strategic plans and best practice departmental procedures for the
therapeutic area group.
Provide
regulatory guidance for top-level project development/core teams.
Actively liaise with FDA and regulatory
authorities to provide/solicit guidance and support for complex
submissions.
Research and develop
regulatory intelligence concerning competitor products and
disseminate competitive intelligence to project and core teams.
Staff training/management and
self-development.
Qualifications:
Bachelors degree in scientific discipline
required (Life Sciences, Chemistry, Toxicology or Pharmacology).
Doctorate degree highly desired (e.g., MD, JD, Pharm D, or PhD in
life sciences).
3-8 years FDA experience
as Project Manager or Clinical Reviewer.
Expert understanding of pharmaceutical operations and regulatory
compliance requirements together with broad understanding and
experience of the clinical development process a plus.
Expertise in managing relationships and
interfacing with regulatory bodies as an articulate communicator
with strong negotiation skills a plus. |
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Salary: Open, Job Type: Permanent, Total Exp: 3-8 Yrs,
Start Date: ASAP,
Location: Ridgefield Park, NJ |
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| Job ID: |
TRS-02158-6 - Associate Director, Regulatory Affairs,
Nonclinical |
| Description: |
Description:
The
incumbent is responsible for but not limited to the following:
- Regulatory expertise within at least 1
related area including clinical trial management, manufacturing,
non-clinical testing and marketed products together with broad
understanding & experience in the clinical development process
- Support regulatory strategy &
contribute to its outcome within the Nonclinical area
- Advise management & recommend
departmental operating procedures/policies to accomplish work more
efficiently & with better quality control
- Define regulatory vision & strategy for
achieving that vision and engages and motivates team to buy into
vision and execute strategy.
- Contribute
to development results by providing regulatory leadership &
assume a supervisory and/or "subject matter expert" role with regard
to regulatory issues.
Qualifications:
Associate Director: MD, JD, PharmD or Ph.D. in the life sciences
highly desired. BS degree required in associated functional
discipline (Life Sciences, Chemistry, Toxicology or Pharmacology)
Associate Director: Minimum 10-12 years
of regulatory experience plus 2-3 years of additional related
experience (i.e., manufacturing, clinical marketed products, etc.)
preferably including some broader industry experience.
Must have experience in interacting with the
appropriate regulatory bodies
Most posess
in-depth knowledge of appropriate Code of Federal Regulations &
Regulatory Guidance Documents
History of
working in complex team environments with numerous/diverse
stakeholders
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Salary: Open, Job Type: Permanent, Total Exp: 10-12 Yrs, Start Date: ASAP,
Location: Ridgefield
Park, 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: |
RC-03058-1 - Associate Medical Director |
| Description: |
Company:
The company is
a privately-held company that specializes in the development of
topical drug/dermatology products for biotechnology and
pharmaceutical clients. It provides a full range of product
development services including formulation, clinical development,
regulatory consulting, analytical support, cGMP clinical
manufacturing and clinical labeling. Located in Northern
California
Description:
The
Associate Medical Director is responsible for medical affairs
activities to support commercial brand strategies, and for providing
medical support to clinical affairs for dermatology clinical
programs in development
Specific responsibilities include:
Provide clinical expertise and approval of
clinical protocols, clinical study-related documents, clinical study
reports
Provide medical leadership of
brand-related medical information and detail aids, clinical
communications, publications, medical information
Lead the development and execution of the
post-approval clinical program in response to regulatory commitments
and brand strategy supporting key medical marketing messages in
partnership with commercial, regulatory, and clinical affairs
Medical/scientific training of all relevant
internal (e.g., marketing, sales, medical information) and external
parties (e.g. speaker training) regarding the brand
Works closely with the commercial team to
help build awareness of products in the medical community
Cultivate key opinion leader relationships
and provide clinical leadership in interactions with key opinion
leaders, advisory boards, patient advocacy groups
Support the communication of scientific and
medical information, specifically the presentation of key data to
the medical community via advisory boards, national and
international meetings, and other scientific venues.
Provide support for the publication strategy
and active involvement in the development of publications
Provide clinical leadership in the evaluation
and management of investigator initiated proposals and development
of a process
Requisite Skills:
Specific skills needed include:
MD or DO required with board
certification/eligibility or equivalent in Dermatology
Medical marketing experience is a plus
Excellent written and verbal communication
skills
At least 2 years experience in a
clinical/medical or industry setting
Good
understanding of strategic marketing acquired by experience or
formal training
Capabilities:
Needed
capabilities include:
Strong computer
literacy skills (including Word, Powerpoint)
Attention to detail
Effective planning (time and project management) skills
Strong interpersonal, negotiation,
communication, and problem solving skills
Proven ability to work well in cross-functional teams
Proven ability to form credible relationships
with national opinion leaders, especially in the field of clinical
dermatology |
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Salary: to 175K + Bonus, Job Type: Permanent, Total Exp: 2+ Yrs,
Start Date: ASAP,
Location: Redwood City, CA |
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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: |
CM-02278-1 - Clinical Project Manager |
| Description: |
Duties and Responsibilities
-Manage the investigative sites by discussing
and resolving protocol, budget, enrollment and staffing issues.
-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: to 110k, Job Type: Permanent, Total Exp: 3-5 Yrs,
Start Date: ASAP,
Location: Norristown, PA |
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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 |
| |
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.
|
| |
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.
|
| |
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.
|
| |
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).
|
| |
Salary: OPEN, Job Type: Permanent, Total Exp: 4-5 Yrs,
Start Date: ASAP,
Location: Chicago, IL |
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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.
|
| |
Salary: OPEN, Job Type: Permanent, Total Exp: 6+ Yrs,
Start Date: ASAP,
Location: Miramar, FL |
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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: |
DS-01108-6 - Director, Clinical Data Management |
| Description: |
Located in central NJ, 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.
|
| |
Salary: 140-160k, Job Type: Permanent, Total Exp: 5 Yrs,
Start Date: ASAP,
Location: Branchberg, 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: |
TB-03038-1 - Director, Project Management |
| Description: |
Position Summary
The
Director, Project Management (DPM) provides direction, strategic
management, oversight, training and support to the clinical research
Project Directors (PD), Project Managers (PM) and their teams to
ensure that company delivers quality projects to its clients, and
achieves or exceeds clinical trials project goals. As a seasoned
project manager the incumbent provides industry expertise and
leadership to project managers on multiple and complex national and
international clinical trials, typically in phases II-III. The
Director, Project Management acts as the point of escalation between
the client and the project team to ensure a successful outcome while
strengthening the client relationship. The DPM is responsible for
maintaining continuous process improvements and for ensuring
adherence to operational excellence, timelines, safety and quality
measures, and revenue recognition/forecasting for a portfolio of
clinical trials projects.
Position Qualifications
Minimum of a Bachelors degree in a science,
health field or industry related discipline required; advanced
degree in related discipline or business preferred.
Minimum 10-15 years industry related
experience with at least 5 years in project management preferably in
a CRO or pharmaceutical company.
Must
have strong clinical trials experience, knowledge of the key factors
involved in effectively servicing and managing the relationship with
pharmaceutical and/or biotechnology companies.
Proven record of strong
supervisory/management and leadership skills.
Demonstrated success with operational/process
driven improvements.
Record of results
orientation with demonstrated drive to meet targets, and act
decisively to ensure completion of projects and growth of
business.
Team player with outstanding
interpersonal skills.
Broad business
expertise.
Client focused approach to work
with track record of excellent stakeholder/relationship management
skills.
Excellent presentation, persuasive
verbal and written communication skills, with ability to influence
others.
Excellent organizational skills
with the ability to manage multiple and varied tasks with
enthusiasm, and prioritize workload with attention to detail.
Strong business acumen and skills in matters
related to resource management and revenue enhancement.
Solid knowledge of industry regulatory laws,
ICH regulations, and GCP.
Ability to
role-model leadership behaviors and the highest level of business
ethics.
Flexibility with respect to work
assignments, new learning and travel.
Willingness to work with multiple stakeholders in a matrix and
global environment.
Experience with
Microsoft based applications and general knowledge of PC
functions.
Location
and Travel
Opportunities exist in San
Diego, CA.
Incumbents typically travel approximately
25%.
Salary
Target $130-150K, based on experience and up to 15% Management
Incentive Bonus eligible
Ideal Candidate
Experience with direct-line management of others, preferably in a
clinical research environment, such as another CRO.
Pharmaceutical experience working with CROs
or outsourced vendors helpful.
Experience
or demonstrated success in client-focused environment (e.g.,
consulting or CRO).
Financial acumen to
oversee budget management, and conduct strategic planning revenue
forecasting.
Should have business
development experience.
Experience in
strategic or leadership position.
Experience managing portfolio of clinical trial projects or programs
through others.
May have extensive
pharmaceutical experience managing vendors and CROs??
Is a polished presenter whose presence with
sponsor/client would add value to position.
Strategic/big-picture thinker.
Confidence needed for situations such as bid
defense.
Can be a therapeutic
generalist.
|
| |
Salary: 130K + 15%, Job Type: Permanent, Total Exp: 5+ Yrs,
Start Date: ASAP,
Location: San Diego, CA |
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| Job ID: |
RC-03058-2 - DIRECTOR/SENIOR DIRECTOR, MEDICAL AFFAIRS HIV
|
| Description: |
POSITION SPECIFICATIONS
DIRECTOR/SENIOR DIRECTOR, MEDICAL AFFAIRS HIV
for a worldwide biopharmaceutical company engaged in the discovery,
development and commercialization of anti-infective therapeutics;
located in the SF, CA area.
OVERVIEW:
Reporting to the VP of Medical Affairs, will have the responsibility
to develop and implement medical strategies and clinical plans for
the companys HIV franchise. Contributes to the management of
relationships with Key Opinion Leaders and directs clinical trial
initiatives, assuring that clinical studies support the franchise
strategy.
RESPONSIBILITIES:
Plans and delivers medical affairs strategies
for the maximization of product potential and commercialization of
HIV drug products.
Prepares and implements
medical affairs research documentation, scientific summaries and
regulatory documentation, including summaries and analysis of
ongoing investigator-initiated studies and clinical study reports
and protocol development for company sponsored clinical trials.
Contributes to the development and
implementation of clinical plans and in particular Phase IV clinical
strategy for HIV. Responsible for providing input into the
therapeutic area and product strategy. Participates in product
review and leads the medical affairs group on the HIV project team
and manages a team of Phase IV HIV personnel. Ensures the timely
development of documents which are medically and scientifically
comprehensive for submission to key opinion leaders, advisory
committees or other internal and external groups.
Writes protocols, including core background
text, and scientific evaluation of study design, and assists in
selecting efficacy/safety parameters and outcomes measures.
Assists in the preparation of abstracts,
posters and communication for scientific meetings and conferences to
maintain awareness of clinical research in HIV.
Works closely with the companys Medical
Scientist group and the Medical Education department in order to
equip them with a total and enhanced view of the companys HIV
initatives and to promote stronger relationships with KOLs.
Develops appropriate alliances with internal
clinical, regulatory, medical communications, and commercial groups
in order to more effectively meet the needs and demands of the
organization.
Collaborates with Commercial
groups on projects such as Speakers meetings and training, Advisory
Boards and scientific conferences and meetings in order to achieve
the companys scientific objectives.
Presents periodic therapeutic and business
reviews for Medical Affairs staff and to senior management members.
| |
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