|Title:||Associate Director, Clinical Pharmacology & Pharmacometrics|
|Department:||Data Management and Biometrics|
|Job Status:||Full Time|
Celerion is searching for a full-time Associate Director, Clinical Pharmacology & Pharmacometrics (CPP) to be based on-site in either our Montreal, Quebec or Lincoln, Nebraska offices.
The candidate will have leadership responsibilities and perform tasks in an autonomous manner and act as a scientific expert, mentor and resource for other members of the Celerion CPP, DMB team.
The candidate will assist the Director in overseeing and managing a group of multi-disciplinary scientists within the CPP department and/or DMB line of services responsible for designing and developing study protocols, conducting pharmacokinetic data analysis, providing scientific interpretation of study results, and clinical study report writing. In addition, as a senior individual in the leadership team, the candidate will participate in supporting business growth through direct interaction with potential and existing clients and/or indirect support via Celerion’s business development team. This entails presenting company capabilities, giving presentations at seminars, webinars, and other marketing events or external scientific meetings, developing external visibility by publishing work, engaging in scientific strategic planning on clinical pharmacology trial designs, providing consultancy services for clients, and participating in client bid defense meetings. The candidate will participate in the development of material and/or lead scientific training for other scientists and provide input in organizational improvements and spearhead implementation of new processes and/or procedures.
- PharmD, MD and/or PhD degree in a biology-focused sciences related field with 10+ years of related experience required*. Candidates with an M.Sc. level designation with 10+ years of directly related experience and a strong track record of scientific and operational leadership will be considered.
- Candidate should have a strong track record of scientific and operational leadership experience in the conduct of clinical studies and should have an excellent working knowledge of ICH regulations and regulatory guidance in several jurisdictions (eg. US FDA, Canada TPD, Europe EMA).
- Candidate should have expert knowledge of clinical pharmacology, pharmacokinetics and pharmacodynamics, required for contributions to study protocol development, analysis plan generation, data analysis, problem solving, interpretation of data and clinical study report production.
- Should be proficient in performing noncompartmental pharmacokinetic analysis independently on studies of varying PK/PD complexities with software applications such as Phoenix WinNonlin.
- Strong familiarity with theory and application (including software use) of non-linear mixed-effect modeling and/or physiologically-based pharmacokinetic modeling is an asset.
- Excellent oral and written skills required (English language).