Senior Director, Clinical Pharmacology
Role Overview
This position leads the design and execution of clinical pharmacology strategies across a broad pipeline of therapeutic approaches. You will shape dosing recommendations, support regulatory filings, and guide development through pharmacokinetic and pharmacodynamic insights. Your expertise will inform critical decisions from early development through approval.
Key Responsibilities
- Develop and implement clinical pharmacology plans aligned with program objectives across multiple therapeutic modalities
- Serve as the primary scientific advisor on clinical pharmacology to senior leadership and project teams
- Represent clinical pharmacology in global regulatory discussions and health authority meetings
- Lead model-informed drug development initiatives, including population PK and exposure-response analyses
- Conduct noncompartmental and compartmental PK analyses using Phoenix WinNonlin
- Oversee external vendors to ensure modeling work meets regulatory standards
- Author clinical pharmacology sections of NDAs, BLAs, protocols, study reports, and regulatory responses
- Ensure scientific accuracy and regulatory compliance in all study documentation
- Mentor junior scientists and potentially manage direct reports
- Stay current with scientific literature and contribute to advancements in clinical pharmacology
Qualifications
Required:
- PhD in pharmacokinetics, pharmacology, pharmaceutical sciences, or a related field
- Minimum of 10 years of industry experience in clinical pharmacology or drug development
- Proven ability to interpret and apply translational PK data in clinical development
- Hands-on experience with Phoenix WinNonlin for PK analysis and reporting
- Track record of authoring regulatory submission content
- Strong understanding of FDA and ICH guidelines
- Effective communication skills with experience collaborating across disciplines
- Familiarity with bioanalytical methods across diverse drug modalities
Preferred:
- Experience with rare disease therapeutics and diverse modalities such as small molecules, biologics, or mRNA
- Background in population PK modeling, QTc assessments, and mechanistic PK/PD modeling
Work Environment
This is a hybrid position requiring 2–3 days per week onsite, with flexibility based on business needs. Occasional travel may be required. The role supports remote work arrangements with periodic in-person collaboration.
Compensation and Benefits
The annual base salary range is $284,600 – $351,500 USD. Additional components include equity incentives, an annual bonus, and a comprehensive benefits package. This includes long-term incentives, employee stock purchase options, generous paid time off, volunteer leave, fitness reimbursement, tuition support, and professional development funding. Wellbeing initiatives are integrated into the employee experience.
Company Culture
The organization is committed to advancing treatments that address patient needs, fostering a supportive and inclusive workplace, and promoting continuous learning. It aims to be a place where employees are proud to build their careers and where future generations would choose to work.
Equal Opportunity Employer
This employer supports workplace diversity and prohibits discrimination based on race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, marital status, or veteran status. Accommodations are available for qualified individuals with disabilities, pregnant employees, and those with sincerely held religious beliefs, in compliance with applicable laws.
