PK/ PD Modeling and Simulation Director - Basel

Recruiter
Barrington James Ltd
Location
London (Greater)
Posted
13 Nov 2017
Closes
16 Nov 2017
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
PK/PD Director supports drug development by providing clinical pharmacology/DMPK/pharmacometric expertise across early and full development phases, and global medical affairs, with a Pharmacology Focus or a Pharmacometrics Focus or some mixture thereof. Supports project teams with modeling- and simulation-based input to program strategies and trial design, evaluations, integrated analysis, and reporting.

Responsibilities:
1. Perform and oversee pharmacometric analyses using a variety of tools and approaches.
Integrate, interpret, and report data to project teams and other customers. Create, advocate, and implement innovative program strategies.
2. Lead the pharmacometric strategy and coordinate activities across projects. Server as mentor for junior pharmacometricians and pharmacologists.
3. Proactively contribute expert input into key pre-clinical and clinical, and regulatory documents including clinical study protocols, clinical study reports, modeling reports, investigator bro-chures, IND / IMPD's and NDA's within agreed timelines, and meeting all regulatory require-ments in consultation with manager.
4. Ensure constructive collaboration within drug development teams (GPTs, etc) and with other internal partners (e.g. DMPK, Toxicology, Formulations, Drug Regulatory Affairs, Clinical Development).
5. Define and update as appropriate the PK, PK/PD, DMPK, biopharmaceutical and pharmaco-metric requirements in the OCP and/or preclinical project development plans.
6. Monitor timelines, objectives and, as appropriate, budgets. Ensure accuracy of project and activity progress in company tracking tools (e.g., Succeed, ModTracker). Assure rapid and ef-fective communication of high-quality data and results to project teams.
7. Follow internal processes and project-specific standards and, when re-quired, adhere to Health Authority requirements (SOPs, Master Analysis Plan, GCP, and regu-latory guidelines). Lead initiatives for creating and updating new processes and standards for OCP.
8. Lead or participate in OCP or project sub-teams. Coordinate with appropriate sub-team members and/or prepare summary documentation
9. Maintain and enhance technical and drug development expertise (e.g. training courses, exter-nal meeting attendance). Initiate training / study sessions within OCP and for other line func-tions. Act as technical subject matter expert in key clinical pharmacology / DMPK / pharma-cometric related area.
10. Attend meetings with external parties including investigators, outside experts, and health au-thorities.
11. Coach and mentor other OCP associates.

Experience/Professional requirement:
1. Relevant postdoctoral, academic, industry, or government experience (9-15 years for Principal Fellow, 6-10 years for Senior Fellow)
2. Integrated knowledge of pharmacometric tools (e.g., WinNonlin, SAS, NONMEM, Trial Simulator, GastroPlus, SymCyp).
3. Integrated knowledge of related disciplines (e.g., DMPK, biostatistics, toxicology, regulatory) in the drug development process.
4. Demonstrated experience and ability to work successsfully as part of cross functional teams in a highly dynamic, matrixed, project-team environment.
5. Excellent oral and written communication skills.
6. Excellent organizational and project skills.
7. Excellent critical thinking and problem solving skills, including publications / presentations.
8. Strong influencing and negotiating skills.
9. Strong coaching, mentoring, and people management skills.

Please direct all questions (if necessary) to "Chris" at ************************** cswain (at) barringtonjames (dot) com alongside a copy of your CV.

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