Senior Director, Clinical Pharmacology

Job Summary:

The Senior Director, Clinical Pharmacology provides clinical pharmacology leadership across development programs, directing PK/PD strategy, modeling and simulation, and dose-selection activities to inform clinical trial design and regulatory submissions. Leads population PK, exposure-response, and other quantitative modeling efforts performed internally or through modeling vendors and translates the resulting insights into dose-selection rationale that shapes protocol design. Serves as the clinical pharmacology voice on cross-functional program teams and represents the function directly with health authorities during meetings and submission reviews. This role requires both technical modeling expertise and the credibility to defend clinical pharmacology strategy in high-stakes regulatory interactions.

Work Arrangement & Location: 

Hybrid - This position follows a hybrid work schedule, requiring a minimum of two (2) days on-site per week — currently designated as Tuesday and Wednesday. Additional on-site days may be required based on business needs, team priorities, or leadership direction.

Essential Duties and Responsibilities:

• Lead clinical pharmacology strategy for assigned programs, including PK/PD study design and dose-selection rationale.
• Direct population PK, exposure-response, and modeling and simulation analyses performed internally or by vendors.
• Author and review clinical pharmacology sections of INDs, NDAs/BLAs, and health authority responses.
• Serve as clinical pharmacology lead on cross-functional program teams, advising on drug-drug interaction and special population studies.
• Represent clinical pharmacology in interactions with health authorities (e.g., FDA/CHMP meetings), including authorship of relevant sections of briefing documents.
• Provide clinical pharmacology assessments to due diligence and licensing evaluations, as applicable.
• Oversee clinical pharmacology CRO and modeling vendor relationships and deliverables.
• Perform other duties and responsibilities as assigned

Qualifications:

• Education: PharmD, PhD in Clinical Pharmacology, Pharmacokinetics, Pharmacometrics, pharmaceutical sicences, or related discipline required.
• 10+ years of clinical pharmacology experience in pharma/biotech, including leadership of PK/PD strategy across development-stage programs.
• 3+ years of vendor management oversight experience with ability to manage and hold CRO/modeling vendors accountable for deliverable quality.
• Experience in immunology, inflammation, autoimmune disease, immune-mediated diseases, T-cell biology, cell therapy, biologics, gene therapy, or other novel therapeutic modalities preferred
• Expertise in population PK/PD modeling, , and relevant software (e.g., NONMEM, R).
• Strong knowledge of ICH and FDA/EMA clinical pharmacology guidance.
• Understanding of drug-drug interaction and special population study design.
• Proven ability to lead clinical pharmacology strategy discussions with senior internal and external stakeholders, including regulators.
• Excellent scientific writing and presentation skills for regulatory submissions and health authority interactions.
• Skilled at defending clinical pharmacology strategy directly with health authorities.
• Demonstrated ability to manage external CROs/vendors and coordinate study execution across multiple stakeholders
• Strong project/program management capability, including timeline planning, cross-functional coordination, risk tracking, deliverable management, and issue escalation.
• Ability to communicate scientific and operational issues clearly to cross-functional teams and senior stakeholders.