Clinical Pharmacology Director

Sumitomo Pharma•Marlborough, MA

4d•Remote

About The Position

The Director, Clinical Pharmacology delivers for patients by providing scientific, strategic, and operational leadership in clinical pharmacology and pharmacometrics across SMPA research and development programs. This role thinks future and acts now to ensure that high-quality clinical pharmacology studies and quantitative analyses inform development and regulatory decisions across the product lifecycle, while acting with integrity and upholding the highest scientific, ethical, and compliance standards. Provide clinical pharmacology support to the Translational Medicine and Early Development (TMED) function.

Requirements

Deep experience in the pharmaceutical/biotechnology industry, particularly in basic drug discovery and development research.
Expertise in Phase 1 clinical study planning and execution (e.g., FIH, SAD, MAD, RI-AME, DDI, organ impairments, special populations, PET/EEG).
Proficiency with Phoenix WinNonlin, and knowledgeable with advanced pharmacometrics tools for modeling & simulation.
Proven leadership and collaboration skills in cross-cultural environments.
Strong communication/negotiation and vendor management skills.
PhD in Pharmaceutics, PharmD, or equivalent advanced degree required.
10+ years of experience in biotech/pharmaceutical drug development, including clinical pharmacology, PK/PK-PD, biomarkers, scientific writing, and regulatory interactions.
Extensive experience in Clinical Pharmacology study design, planning, and execution.
Requires ability to use a personal computer for extended periods of time.
Excellent written and oral communication skills required.
Must be able to exercise appropriate judgment as necessary.
Requires a high level of initiative and independence.

Nice To Haves

This position may be developed to have people-management responsibilities in near future, i.e. 1 or 2 years later.

Responsibilities

Integrate the clinical pharmacology strategy within overall clinical development plans, ensuring scientific rigor, patient safety, and compliance with global regulatory expectations (e.g., ICH, FDA, EMA, PMDA etc.).
Work with cross-functional development teams to align assumptions, resolve issues, and enable timely decisions using clinical pharmacology and quantitative evidence.
Lead Phase 1 and special population clinical pharmacology studies (e.g., FIH, SAD, MAD, DDI, organ impairments, elderly/pediatric, PET/EEG), including protocol input, operational oversight, and interpretation and communication of results.
Provide support to the TMED function, including early development strategy, study design, and quantitative interpretation to inform program decisions.
Drive PK, PK/PD, exposure–response, and biomarker quantitative strategy; translate analyses into clear recommendations that inform patient-focused benefit–risk decisions.
Advance pharmacometrics excellence through population modeling and simulation; set outsourcing approach and oversee partners for critical-path deliverables, timelines, and budget.
Provide clinical pharmacology content for key program documents (e.g., protocol sections, Investigator’s Brochure contributions as applicable, and clinical study reports), ensuring data integrity and a clear scientific rationale.
When opportunity appears, develop talent through hiring, coaching, mentoring, and performance management; set expectations for quality, compliance, and delivery across the team and external partners.
Lead clinical pharmacology deliverables for regulatory interactions (e.g., briefing materials, responses, and meeting support) and maintain alignment to evolving global expectations.
Support post-approval commitments and lifecycle management through design, execution, and interpretation of additional studies and quantitative analyses.
Provide overall clinical pharmacology input to due diligence and business development activities, including assessment of available data packages and future development needs.
Represent SMPA externally through publications, presentations, and collaborations that strengthen science and advance clinical pharmacology best practices.