Senior Manager, 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 Manager, Clinical Pharmacology conducts pharmacokinetic/toxicokinetic studies to support preclinical and clinical development of novel therapies and life cycle management. This role collaborates with discovery and development teams, as well as colleagues in clinical pharmacology and DMPK, to implement clinical pharmacology strategies for drug development. The incumbent will perform hands-on non-compartmental analysis (NCA), manage related software and data archiving packages, and maintain standard operating procedures (SOPs) and working instructions. Strong cross-functional collaboration with internal and external partners—including Discovery Research, Clinical Development, Clinical Operations, Medical Writing, and Regulatory Affairs—is essential to advance therapeutic candidates efficiently. This individual may also lead operational and project activities as assigned.

Responsibilities

• Conducts pharmacokinetics and toxicokinetics analysis to support preclinical and clinical drug discovery and development.
• Prepares study protocols, scientific reports, and presentations related to preclinical and clinical studies.
• Assists in developing clinical study and regulatory documents, such as protocols, analysis plans, INDs, and NDAs.
• Generates and maintains standard operating procedures (SOPs) and work instructions.
• Complies with SOPs and all relevant regulatory guidelines.
• Manages PK (and PD) analysis software packages (e.g., Phoenix WinNonlin, PK Submit) and data archiving systems (e.g., DS Integral).
• Provides direct support for operational and project leadership activities as assigned by the manager.
• Evaluates and selects Contract Research Organizations (CROs) and oversees outsourced PK, PK/PD, and exposure-response analyses.

Requirements

• PhD or PharmD in a relevant scientific discipline with a minimum of 5 years of progressively responsible experience in a pharmaceutical, biotechnology, or related environment, or an equivalent combination of experience and education.
• Hands-on experience with non-compartmental (NCA) PK analysis to support preclinical and clinical pharmacokinetic/toxicokinetic studies.
• Proficiency with PK analysis software packages (e.g., Phoenix WinNonlin).
• Demonstrated experience in writing study reports and regulatory documents.
• Excellent planning, organization, and time management skills, including the ability to support and prioritize multiple projects.
• Strong verbal and written communication skills, with the ability to influence without direct authority.
• Ability to work independently and collaboratively in a fast-paced, matrixed team environment with internal and external stakeholders.
• Analytical thinker with excellent problem-solving skills and adaptability to changing priorities and deadlines.
• Strong management and interpersonal skills.

Preferred Qualifications

• Drug metabolism and bioanalysis experience.
• Experience with R, DS Integral, and NONMEM.
• Data-handling skills and solid understanding of clinical database structures, such as SDTM and ADaM.

Pay

Expected base salary range: $127,600 – $160,600. The base salary offered will be contingent on the candidate’s education, background, and experience, as well as internal equity. In addition to base salary, employees are eligible for short- and long-term incentives.

Benefits

All eligible employees may enroll in PTC’s medical, dental, vision, and retirement savings plans.

Schedule

Travel requirements: 0–10%.