Senior Director, Clinical Pharmacology

Job Description Summary

The Senior Director, Clinical Pharmacology supports PTC’s Clinical Development function by providing hands-on support for Clinical Pharmacology. Key responsibilities include PK & PK/PD assessment, data interpretation, and project management.

ESSENTIAL FUNCTIONS

• Establishes Clinical Pharmacology strategies aligned with team goals and regulatory requirements.
• Designs, conducts, and manages PK & PK/PD studies, and interprets data.
• Serves as the lead clinical pharmacologist for clinical stage programs, representing clinical pharmacology on multidisciplinary projects.
• Develops and writes relevant documents including IB, protocols, study reports, IND/NDA, eCTDs, and regulatory documents.
• Collaborates with functional groups within clinical pharmacology & DMPK and other stakeholders.
• Communicates clinical pharmacology & DMPK-related data to multidisciplinary project teams, management, and regulatory authorities.
• Ensures the scientific quality of clinical pharmacology data in support of development programs.
• Manages collaboration with external CROs in PK, PK/PD, and E/R analysis.
• Performs other tasks and assignments as needed and specified by management.
• May manage, coach, and/or mentor direct reports or junior clinical pharmacologists.

Knowledge/Skills/Abilities Required

• Minimum of 9 years of relevant and progressively responsible experience in clinical pharmacology, including extensive experience in DMPK.
• Broad understanding of clinical pharmacology & DMPK relevant areas such as PK assessment in patients, exposure-responses relationship analysis, PK modeling, DDI, physicochemical properties, drug metabolizing enzyme & transporter kinetics, pharmacokinetics, mechanistic biotransformation, and analytical sciences.
• Proficiency in NCA PK (WinNonlin) and hands-on experience in PBPK and popPK modeling.
• Experience in managing projects and leading clinical pharmacology strategy.
• Strong understanding of regulatory guidelines for clinical pharmacology & DMPK packages to support drug development.
• Excellent verbal and written communication skills, ability to work independently and collaboratively, and adapt to changing priorities and deadlines.
• Analytical thinker with excellent problem-solving skills and excellent planning, organization, and time management skills.

Expected Base Salary Range

$237,400 - $298,900

The base salary offered will be contingent on assessment of candidate education level, background, and experience relative to the requirements of the position they are being considered for, as well as review of internal equity. In addition to base salary, PTC employees are also eligible for short- and long-term incentives. All eligible employees may also enroll in PTC’s medical, dental, vision, and retirement savings plans.

EEO Statement

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.