🚀 Quantitive Lead

Are you ready to play a pivotal role in shaping the future of drug development? A leading global biopharma organization is seeking a Senior Director to lead its Clinical Pharmacology function , providing scientific, strategic, and operational leadership across multiple therapeutic programs.

This is an exciting opportunity for a seasoned clinical pharmacologist or pharmacometrician with deep experience in the development of new medicines, particularly from early-stage trials through late-phase and post-marketing efforts.

About the Role

As the senior clinical pharmacology lead, you will guide and oversee the planning, execution, and interpretation of pharmacokinetic and pharmacodynamic studies across several drug development programs. This includes integrating model-based strategies, managing collaborations with cross-functional teams, and leading regulatory interactions.

You’ll be instrumental in shaping strategy, ensuring compliance, mentoring scientific staff, and contributing to the continued success of a pipeline focused on transforming patient care globally.

Key Responsibilities

• Lead clinical pharmacology strategies across multiple clinical programs from Phase 1 to post-approval stages.
• Design and implement plans that integrate modeling and simulation (M&S) approaches, collaborating with key internal partners in pharmacometrics, drug metabolism, and regulatory affairs.
• Drive adoption of advanced analytical methods (e.g., QSP, MBMA) to support decision-making and regulatory submissions.
• Prepare or oversee the creation of regulatory documents including IBs, CTAs, clinical study reports, and product labels.
• Analyze and interpret PK/PD data, working alongside internal and external stakeholders including CROs.
• Act as the primary representative of the clinical pharmacology function in global program meetings and health authority discussions.
• Provide mentorship and leadership to junior team members, helping foster professional growth and scientific excellence.
• Contribute to high-level departmental strategy and support due diligence activities for potential partnerships or acquisitions.

Qualifications

• PharmD, PhD, MS, or BS in a relevant scientific discipline with significant industry experience:
• PhD or PharmD: 16+ years
• MS: 18+ years
• BS: 20+ years
• Demonstrated success in clinical pharmacology or related areas, particularly in overseeing strategy across multiple therapeutic areas.
• In-depth knowledge of pharmacokinetics, pharmacodynamics, and regulatory expectations for drug development.
• Strong track record of implementing model-informed drug development (MIDD) practices.
• Excellent cross-functional collaboration skills with the ability to influence teams and align stakeholders.
• Experience leading regulatory discussions and contributing to high-stakes submissions.
• Previous experience managing or mentoring scientific teams is preferred.

Work Arrangement

This position follows a hybrid work structure , allowing for flexibility between remote work and on-site collaboration at the Cambridge office.

Compensation and Benefits

• Estimated Salary Range: $208,200 – $327,140 (based on experience, qualifications, and location)
• Competitive performance-based incentive plans
• Comprehensive health coverage: medical, dental, vision
• 401(k) plan with company match
• Paid vacation, sick time, and company holidays
• Life insurance, disability benefits, and wellness support
• Tuition reimbursement and professional development resources
• Generous paid time off for volunteering