Thank YOU, and I appreciate YOU for expressing interest in this posting ! ... Please take NOTE and make sure that YOU match ALL the Job Specifications outlined below ... My Client has very Specific Requirements ... Please understand these are very $ HIGH PAYING $ positions and so Criteria matching is crucial for YOUR Placement ! ... We recognize that the foundation for providing excellent service begins with recruiting exceptional candidates, cultivating YOUR talents, and Integration with our Client ...
Program Mgr-Pharmacokinetics/Drug Metabolis
Pharmaceutical / Biotech
Medical / Health - Lab
United States - North Carolina - Durham
Benefits - Full
Relocation Assistance Available - Yes
Commission Compensation - No
Bonus Eligible - Yes
Overtime Eligible - No
Interview Travel Reimbursed - Yes
Responsible for program-level strategic and resource planning, communication, scientific/technical deliverables, issue resolution and functional representation for internal governance reviews, face-to-face interactions with global regulatory authorities and external scientific communities.
The individual will effectively lead project team and interface with internal business stakeholders (i.e., Clinical & Regulatory Affairs, Research & Development). This individual will be responsible for the PK, PK/PD, and Modeling & Simulation strategy, to prepare regulatory documents as a PK/PD expert, and represent our company in global regulatory interactions.
The ideal candidate will have successfully delivered a minimum of one clinical trial through FDA approval and have the confidence to interact on defense presentations constructing scientific statistical reasoning and defenses to FDA/regulatory authorities.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
1. Responsible for the development and implementation of the pharmacokinetic and pharmacodynamics elements of pre-clinical and clinical development plans in support of early development and registration studies for musculoskeletal based therapies.
2. Facilitates constructive collaboration within the project team and with associated functions, such as Clinical & Regulatory Affairs.
3. Identifies potential project hurdles, suggests solutions and establishes contingency plans.
4. Prepares study protocols and reports within agreed timeframes and which meet regulatory requirements.
5. Monitors study timelines, objectives and budgets; ensures accuracy of plans.
6. Assures rapid and effective communication of data to project team.
7. Manages and coordinates relationships with regulatory authorities, as required.
8. Maintains scientific and regulatory expertise in PK and ADME (i.e., training courses, external meeting attendance).
EDUCATION and/or EXPERIENCE:
- Ph.D. (or MS/BS with equivalent experience) in PK, Pharmaceutical Sciences, Engineering Pharmacology, Life Sciences, Biostatistics or with equivalent professional degrees (i.e., MD or PharmD) with 7+ years' experience in the Biotechnology/Pharmaceutical industry or post-doctoral training is required.
- Experience in PK/PD modeling and population-based analyses/simulations and PK analysis in the areas of ADME (human and animal)Experience in authoring regulatory documentations (IND,, CTD, etc.), knowledge in global regulatory requirement and guidance and interaction with global health authorities.
- Experience with pharmacokinetic, pharmacodynamics and biopharmaceutical data analysis and modeling in the areas of (human and animal).
- Advanced knowledge of clinical trial design and analysis principles, especially Phase 1 and Exposure-Response PK analysis in registration studies.
- Proven record as team player with good negotiation skills
- Ability to influence others; high energy level; self-demanding
- Have a questioning and challenging mindset, with a "what if" mentality.
More About the Position
Visa Candidates Considered - No
7+ to 10 years of experience
Management Experience Required - No
Minimum Education - Doctoral
Willingness to Travel - Occasionally
Candidate Screening Questions
Does the candidate have advanced knowledge of clinical trial design and analysis principles; especially Phase I and modeling in the areas of ADME (human and animal)?
Does the candidate have PK/PD modeling experience?
Does the candidate have 7 years of experience in the Biotech/Pharma industry?
Is the candidate a Ph.D?