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Associate Director, Clinical Pharmacology

  • Location: Cambridge, MA

Posted about 1 month ago

  • Expiry Date: 27 November 2021

​SciPro is excited to partner with a top pharma company on the search for an Associate Director, Clinical Pharmacology supporting their Research Units in Cambridge, MA. The ideal candidate embraces MIDD - constructs, validates, and utilizes disease, placebo, exposure-response, and mechanistic PKPD models to evaluate risk/benefit and facilitate drug development decisions, in close collaboration with other R&D partners. Clinical Pharmacology Leads are also responsible for planning and direction of clinical pharmacology components of clinical programs (including clinical development plan/life cycle plan) and studies (including protocol preparation; clinical phase oversight, and reporting).

RESPONSIBILITIES:

  • Act as Clinical Pharmacology representative on Clinical Sub Team and Development Team as appropriate.

  • Participate in implementing MIDD using quantitative approaches to address complex questions arising during drug development spanning from target validation to analysis and interpretation of Phase II results.

  • Responsible for providing the clinical pharmacology components of Clinical Plans and provides clinical pharmacology expertise to the project team including plan, design and oversee clinical  pharmacology studies with operational assistance from operations colleagues.

  • Fully knowledgeable about the clinical pharmacology profile of allocated drugs on which studies are being conducted or which are called for in the protocol.

  • Coordinates with medical writers (and other team members) in the data review, analysis and reporting of the CP study.

  • Responsible, in conjunction with medical writer, for overall content and accuracy of study report before forwarding for final sign-off.

  • Accountable and responsible for non-compartmental analysis of PK data and accountable and – as appropriate – responsible for ensuring appropriate PK-PD analysis including population PK, PK-PD modeling and simulation, meta-analysis etc.

  • Directs the planning of all relevant PK-PD analyses. Responsible for use of innovative analytical methods to integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics and disease states to optimize doses, dosage regimens and study designs throughout clinical drug development in collaboration with pharmacometrics and statistics (as relevant).

  • Provides recommendations for clinical doses and dosing algorithms (including drug interaction advice, food effects, special group dosing, etc.) to the clinical and Development teams and in regulatory documentation.

  • Leads clinical pharmacology contributions to all regulatory documents including IND, CTA, Investigator Brochures, EOP2 meetings.

  • Leads the resolution of clinical pharmacology queries from drug regulatory agencies, takes a lead role in writing and reviewing responses to regulatory queries.

  • Provides Clinical Pharmacology expertise to Drug Discovery. During the pre-clinical stages of drug development works with Research to ensure quantitative mechanistic understanding and preclinical PK-PD knowledge exist to underwrite human administration.

  • Accountable for ensuring that there are valid methods for measuring drug concentration (and any biochemical biomarkers) in the clinic.

Qualifications:

  • PhD in Clinical Pharmacology, Pharmacokinetics, Pharmacometrics, Engineering or other suitable post-graduate qualification.

  • >4 years of industry experience in clinical pharmacology and/or clinical PK/PD and/or Pharmacometrics.

  • Strong quantitative skills and expertise (e.g. experience in PKPD modeling/systems pharmacology, literature meta-analyses, population modeling, and clinical trial simulations using NONMEM, R, etc.)