Senior Manager, Clinical Pharmacology

Job Description Summary

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.

Essential Functions

• 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.
• Affords assistance 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 guidelines.
• 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.

Knowledge/Skills/Abilities Required

• Minimum level of education and years of relevant work experience: 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.
• An analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Excellent management and interpersonal skills.
• Special knowledge or skills and/or licenses or certificates preferred: 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.

Travel Requirements

0-10%

Expected Base Salary Range

$127,600 - $160,600

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. Click here to return to the careers page