Senior Director, Quantitative Pharmacology

About the role

This role oversees clinical Pharmacology activities, assists in department technical growth, contributes to key metrics of success, supports the head of Quantitative Pharmacology, mentors/trains junior scientists, leads project-level clinical pharmacology activities, develops SOP/WPs, and reviews and approves Clinical Pharmacology reports and analyses.

Responsibilities

• Serve as clinical pharmacology lead on multiple cross-functional project teams; plan and optimize clinical pharmacology strategies and integrate them into clinical development plans to support drug development and regulatory packages of small or large molecule drugs.
• Review, approve and lead development of clinical pharmacology sections for regulatory filings, including annual reports, investigator’s brochure, IND/NDA/BLA applications and pediatrics development plans in compliance with relevant guidelines and standards.
• Work closely with pharmacometrics team, support model-based drug development (MIDD) strategies, and provide input to PK and PK/PD modeling analysis to support dose selection, efficacy and safety assessments.
• Work closely with Translational and biomarker team, support biomarker development and incorporation into early phase studies.
• Responsible for use of innovative methods of data analysis to integrate knowledge of PK, PD, patient characteristics and disease states to optimize doses, dosage regimens and study designs throughout clinical drug development in collaboration with pharmacometrics, biomarker, statistics and clinical development functions (as relevant).
• Review and approve clinical study design and protocols of healthy subject trials (including FIH SAD/MAD, DDI, rBA, mass-balance, HI/RI, TQT,...)
• Interact cross-functionally with other key disciplines involved in drug development including nonclinical pharmacology/toxicology, ADME, clinical, regulatory, and CMC.
• Work with formulation, biomarker and bioanalytical team members on activities related to formulation development, assay development, sample management, Pharmacogenomics (PGx) and biomarker strategy development.
• Train and manage junior team members in Quantitative Pharmacology team.
• Mentor and develop clinical pharmacology talent as the pipeline and organization grow.

Requirements

Extensive experience developing and executing clinical pharmacology strategies for early-through late-stage programs, including registrational support. In-depth knowledge of early phase study design, PK, PD, drug metabolism, biopharmaceutics, biomarker and bioanalytical assay in small molecule and monoclonal antibody (mAb) assets. Hands-on experience in PK and PK/PD data analysis and, Phoenix NLME, etc. Excellent working knowledge of phase I clinical operations, principle of drug development, multi-region regulatory requirements and PK/PD analysis. Great working knowledge of formulation development and clinical development. Current awareness of the latest developments in clinical pharmacology, pharmacometrics and guidance documents.

Qualifications/Required Knowledge and Competencies

• PhD in Clinical Pharmacology (or a related area such as pharmacokinetics, pharmacology, pharmaceutics) with a minimum of 12 years of experience in these areas.
• Experience in early-phase clinical protocol development is a plus.

Skills

• Apply scientific knowledge (in the areas specified above) to further the company’s products, anticipate and identify core problems, apply insightful analysis, and solve problems effectively.
• Strong leadership experience related to clinical pharmacology.
• Strong organization skills.
• Strong communication skills.
• Flexibility to react rapidly to changing situations/environment.

Benefits

Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.