Senior Director, Clinical Pharmacology

PTC Therapeutics is a global commercial biopharmaceutical company.

The Senior Director, Clinical Pharmacology is responsible for providing hands‑on support for Clinical Pharmacology to PTC’s Clinical Development function. This includes performing, coordinating, and overseeing PK & PK/PD assessment(s) in patients; interpreting data; and providing timely Clinical Pharmacology‑related support to various functions, including clinical, biostatistics, medical writing, regulatory, commercial, toxicology, preclinical pharmacology, discovery research, and external CROs. The incumbent is also responsible for providing project management support for selected clinical development projects, including the delivery of all relevant clinical pharmacology studies.

The incumbent works cross‑functionally with internal departments and external resources in PTC’s program teams. The Senior Director, Clinical Pharmacology may manage direct reports and ensures adherence to relevant regulatory requirements and company SOPs.

• Establish clinical pharmacology strategies that align with team goals and meet regulatory requirements (IND and NDA, etc.).
• Act as the lead clinical pharmacologist for clinical‑stage programs: design, conduct, and manage assigned clinical pharmacology studies (PK, PK/PD, PBPK, popPK, DDI, FE, PK in special populations) and perform hands‑on data interpretation.
• Represent clinical pharmacology on multidisciplinary projects and provide scientific leadership and strategic direction to clinical programs.
• Serve as the subject‑matter expert for clinical pharmacology in development teams, including FIH: conduct human PK parameters, exposure projection using in‑vitro and animal PK data, estimate MRSD, and design optimal dose‑finding strategies.
• Develop and write relevant documents (IB, protocols, study reports, IND/NDA, eCTDs, regulatory documents) in close partnership with clinical operations, medical, regulatory, biostatistics, and medical writing teams.
• Collaborate closely with functional groups within clinical pharmacology and DMPK and other stakeholders.
• Effectively 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 in support of development programs.
• Identify and manage collaboration with external CROs in PK, PK/PD, and exposure‑response analysis.
• Perform other tasks and assignments as needed and specified by management.
• May manage, coach, and/or mentor direct reports or junior clinical pharmacologists.

• Ph.D., Pharm.
  
  D., or equivalent academic training in pharmacokinetics, pharmaceutical sciences, or a related discipline, and a minimum of 9 years of progressively responsible experience in clinical pharmacology, including extensive experience in DMPK.
• Broad understanding of clinical pharmacology & DMPK areas such as PK assessment in patients, exposure‑response relationship analysis, PK modeling, DDI, physicochemical properties, drug‑metabolizing enzyme & transporter kinetics, mechanistic biotransformation, and analytical sciences.
• Proficiency in NCA PK (Win Nonlin) and hands‑on experience in PBPK and popPK modeling.
• Experience leading clinical pharmacology strategy and communicating data‑driven recommendations effectively to technical and non‑technical stakeholders.
• Experience managing projects.
• Strong understanding of regulatory guidelines for clinical pharmacology & DMPK packages.
• Ability to work with sometimes conflicting priority settings to adhere to project and team timelines.
• Demonstrated experience writing study reports and regulatory documents.
• Demonstrated leadership ability and ability to influence without direct authority.
• Excellent verbal and written communication skills.
• Ability to work independently and collaboratively in a fast‑paced, matrixed team environment.
• Analytical thinker with excellent problem‑solving skills and adaptability to changing priorities and deadlines.
• Excellent planning, organization, and time‑management skills, including support and prioritization of multiple projects.
• Proficient people and project management experience.

Travel requirements: up to 10%.

Physical requirements:

office/laboratory based position.

Expected Base Salary Range: $237,400 - $298,900.

PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.