Us PTC Therapeutics

Senior Manager, Clinical Pharmacology

USA - New Jersey - Warren · Senior · Contract

Sponsorship not specified$128k-$161kDetected 32 days ago

PharmacologyFDA RegulatoryResearchAnimal StudiesLeadershipCommunicationCollaborationProblem SolvingTime ManagementPublic SpeakingRegulatory Affairs

About the role

PTC Therapeutics is a global commercial biopharmaceutical company.
For over 25 years our team has been deeply committed to a unified purpose: Extending life's moments for children and adults living with a rare disease.
We welcome candidates from all backgrounds to join our team, fostering a strong sense of belonging.

Conducts pharmacokinetics and toxicokinetics analysis to support preclinical and clinical drug discovery and development.
Assists in developing clinical study and regulatory documents, e.g. protocols, analysis plans, INDs and NDAs.
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.
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.
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.

Hands-on experience with non-compartmental (NCA) PK analysis to support preclinical and clinical pharmacokinetic/toxicokinetic studies.
Ability to work independently and collaboratively as required, in a fast-paced, matrixed team environment consisting of internal and external team members.

Minimum level of education and years of relevant work experience.
Special knowledge or skills needed and/or licenses or certificates required.
Proficiency with PK analysis software packages (such as Phoenix WinNonlin).
Excellent verbal and written communication and skills with the ability to influence without direct authority.
Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
Excellent management and interpersonal skills.
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%

The base salary offered will be contingent on assessment of the candidate's 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.
$127,600 - $160,600.

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

Extending life's moments for children and adults living with a rare disease.
At PTC, we cultivate an inclusive culture where everyone feels valued, respected, and empowered.
Visit our website to learn more about our company and culture!

PTC Therapeutics is an equal opportunity employer.
We are committed to treating all applicants fairly and avoiding discrimination.
Click here to return to the careers page
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.

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