Senior Director, Clinical Pharmacology (Biotech)

Location: Hybrid in Boston, Massachusetts, with at least two on-site days per week, currently Tuesday and Wednesday.

Salary: $266,000–$344,000 USD annually, plus potential discretionary annual bonus and long-term incentive award.

Company

hirify.global is a clinical-stage biotechnology company developing precision therapies for autoimmune and inflammatory diseases.

What you will do

• Lead clinical pharmacology strategy across development programs, including PK/PD study design and dose-selection rationale.
• Direct population PK, exposure-response, and modeling and simulation analyses conducted internally or by vendors.
• Author and review clinical pharmacology sections of INDs, NDAs, BLAs, briefing documents, and health authority responses.
• Serve as the clinical pharmacology lead on cross-functional program teams, advising on drug-drug interaction and special population studies.
• Represent clinical pharmacology in FDA, CHMP, and other health authority interactions.
• Oversee CRO and modeling vendor relationships, deliverables, study execution, and quality.

Requirements

• PharmD or PhD in Clinical Pharmacology, Pharmacokinetics, Pharmacometrics, Pharmaceutical Sciences, or a related discipline.
• 10+ years of clinical pharmacology experience in pharma or biotech, including leadership of PK/PD strategy across development programs.
• 3+ years of experience overseeing vendors or CROs and managing deliverable quality.
• Expertise in population PK/PD modeling, modeling and simulation, and relevant software such as NONMEM and R.
• Strong knowledge of ICH and FDA/EMA clinical pharmacology guidance, drug-drug interaction studies, and special population study design.
• Excellent scientific writing, presentation, project management, cross-functional coordination, and regulatory communication skills.

Nice to have

• Experience in immunology, inflammation, autoimmune or immune-mediated diseases, T-cell biology, cell therapy, biologics, gene therapy, or other novel therapeutic modalities.
• Experience providing clinical pharmacology assessments for due diligence and licensing evaluations.

Culture & Benefits

• Hybrid work arrangements with location-specific flexibility.
• Health and wellness coverage tailored to the country and region of hire.
• Paid time off, public holidays, and additional leave according to local requirements.
• Potential annual bonus and long-term incentive award based on individual and company performance.