Associate Director, Clinical Pharmacology

Role Summary

You will join a team of scientists supporting oncology clinical development programs. You will be the primary Clinical Pharmacology Lead providing clinical pharmacology expertise to a multidisciplinary project team for oncology programs.

Responsibilities

• Represent Clinical Pharmacology on Clinical Sub Team and Development Team.
• Participate in the implementation of model-based drug development using quantitative approaches to address complex questions arising during drug development spanning from target validation to analysis and interpretation of Phase III results.
• Provide 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
• Serve as an expert on the clinical pharmacology profile of allocated drugs on which studies are being conducted or which are called for in the protocol.
• Coordinate with Medical Writers (and other team members) in the data review, analysis and reporting of the CP study. Share responsibility with Medical Writer, for overall content and accuracy of study report before forwarding for final sign-off.
• Responsible and accountable for non-compartmental analysis of PK data and accountable for ensuring appropriate PK-PD analysis including population PK, PK-PD modeling and simulation, and meta-analysis.
• Directs the planning of all relevant PK-PD analyses. Use 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).
• Provide 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 and interactions.
• Provide Clinical Pharmacology expertise to Discovery during the pre-clinical stages of drug development and works with Research to ensure quantitative mechanistic understanding and preclinical PK-PD knowledge exist to underwrite human administration.
• Ensure that there are valid methods for measuring drug concentration (and any biochemical biomarkers) in the clinic.
• Participate in multidisciplinary teams in assessing potential in-licensing opportunities, as requested by line management.
• As necessary, act as clinician for Phase I studies or clinical lead / research project lead for specific drug development projects.

Qualifications

• Required: PhD or PharmD
• Required: 3+ years of related experience
• Required: Experience applying pharmacokinetic and pharmacokinetic-pharmacodynamic concepts, including modeling and simulation to clinical trial design.
• Required: Clinical drug development experience in oncology or other therapeutic area
• Required: Strong communication skills--written, verbal and presentation

Preferred Qualifications

• Preferred: Strong technical proficiency with pharmacokinetic software (e.g., WinNonlin, NONMEM, S-Plus, R)
• Preferred: Demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.