Senior Manager, Clinical Pharmacology

PTC Therapeutics • Warren, MI

31d

About The Position

The Senior Manager, Clinical Pharmacology conducts pharmacokinetic/toxicokinetic studies to support preclinical and clinical development of novel therapies and life cycle management. The incumbent collaborates with discovery and development teams, as well as colleagues in clinical pharmacology and DMPK team to implement clinical pharmacology strategies for drug development. This role involves hands-on executing non-compartmental analysis (NCA); managing and maintaining related software and data archiving packages; reviewing, maintaining, and generating related standard operation procedures (SOPs) and working instructions; strong cross-functional collaboration with internal and external partners, including Discovery Research, Clinical Development and Clinical Operations, Medical Writing, and Regulatory Affairs to advance therapeutic candidate in an efficient manner. This individual may also be responsible for operational and project leadership activities as assigned by the manager. The Senior Manager, Clinical Pharmacology supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Requirements

• PhD/PharmD in a relevant scientific discipline with a minimum of 5 years of progressively responsible experience in a pharmaceutical, biotechnology or related environment OR 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 (such as 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.
• Excellent verbal and written communication and skills with the ability to influence without direct authority.
• Ability to work independently and collaboratively as required, in a fast-paced, matrixed team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Excellent management and interpersonal skills.

Nice To Haves

• Drug metabolism and bioanalysis experience preferred.
• Experiences in R, DS Integral, and NONMEM are highly preferred.
• Data-handling skills and solid understanding of clinical database structures, such as SDTM and ADaM

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, e.g. protocols, analysis plans, INDs and NDAs.
• Generates standard operating procedures (SOP) and work instructions
• Complies with SOPs and all relevant regulatory guideline.
• Manages PK (and PD) analysis software packages (e.g. Phoenix WonNonlin, PK Submit, and relevant packages) and data archiving system (e.g. DS integral).
• May provide direct support for the operational and project leadership activities as assigned by the manager.
• Evaluates and selects Contract Research Organizations (CROs) and actively oversees outsourced PK, PK/PD, and exposure-response analyses.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree