Senior Director, Clinical Pharmacology

About the role

PTC Therapeutics is a global commercial biopharmaceutical company dedicated to extending life’s moments for children and adults living with rare diseases. The Senior Director, Clinical Pharmacology provides hands-on support for Clinical Pharmacology within PTC’s Clinical Development function, including performing, coordinating, and overseeing PK & PK/PD assessments in patients, interpreting data, and delivering timely Clinical Pharmacology-related support to clinical, biostatistics, medical writing, regulatory, commercial, toxicology, preclinical pharmacology, discovery research, and external Contract Research Organizations (CROs). This role also includes project management for select clinical development projects and cross-functional collaboration with internal and external teams. The incumbent may manage direct reports and ensures adherence to regulatory requirements and company SOPs.

Responsibilities

• Establish Clinical Pharmacology strategies aligned with team goals and regulatory requirements (IND, NDA, etc.).
• Act as the lead clinical pharmacologist for clinical stage programs; design, conduct, and manage clinical pharmacology studies (PK, PK/PD, PBPK, popPK, DDI, FE, and PK in special populations) and perform hands-on data interpretation.
• Represent clinical pharmacology on multidisciplinary projects, providing scientific leadership and strategic direction.
• Serve as the subject matter expert for clinical pharmacology in development teams, including First-in-Human (FIH) studies by conducting human PK parameter and exposure projections, estimating Maximum Recommended Starting Dose (MRSD), and designing optimal dose-finding strategies.
• Develop and write relevant documents, including Investigator’s Brochures (IB), protocols, study reports, IND/NDA submissions, eCTDs, and regulatory documents in partnership with clinical operations, medical, regulatory, biostatistics, and medical writing teams.
• Collaborate closely with functional groups within clinical pharmacology & DMPK and other stakeholders.
• Communicate clinical pharmacology & DMPK-related data and their relevance to multidisciplinary project teams, management, and regulatory authorities.
• Ensure the scientific quality of clinical pharmacology data supporting development programs.
• Identify and manage collaborations with external CROs for PK, PK/PD, and Exposure/Response (E/R) analysis.
• Perform additional tasks as assigned by management.
• May manage, coach, and mentor direct reports or junior clinical pharmacologists.

Requirements

• Ph.D., Pharm.D., or equivalent academic training in pharmacokinetics, pharmaceutical sciences, or a related discipline.
• Minimum of 9 years of relevant and progressively responsible experience in clinical pharmacology, including extensive experience in DMPK within a pharmaceutical, biotechnology, or related environment, or equivalent experience and/or education.

Skills

• Broad understanding of clinical pharmacology & DMPK areas, including PK assessment in patients, exposure-response relationship analysis, PK modeling, DDI, physicochemical properties, drug-metabolizing enzyme & transporter kinetics, pharmacokinetics, mechanistic biotransformation, and analytical sciences.
• Proficiency in Non-Compartmental Analysis (NCA) PK (WinNonlin) and hands-on experience in PBPK and popPK modeling.
• Ability to lead clinical pharmacology strategy and communicate data-driven recommendations to technical and non-technical stakeholders.
• Project management experience.
• Strong understanding of regulatory guidelines for clinical pharmacology & DMPK packages supporting drug development.
• Ability to manage conflicting priorities and adhere to project timelines.
• Demonstrated experience writing study reports and regulatory documents.
• Leadership ability and capacity to influence without direct authority.
• Excellent verbal and written communication skills.
• Ability to work independently and collaboratively in a fast-paced, matrixed team environment with internal and external stakeholders.
• Analytical thinking with strong problem-solving skills and adaptability to changing priorities and deadlines.
• Strong planning, organizational, and time management skills, including the ability to support and prioritize multiple projects.
• Preferred: Proficient people and project management experience.

Travel

Up to 10%.

Pay

Expected base salary range: $237,400 - $298,900. The base salary offered will be contingent on candidate education, background, and experience relative to the role’s requirements, as well as internal equity. Eligible employees may also participate in short- and long-term incentives and enroll in PTC’s medical, dental, vision, and retirement savings plans.