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.
At PTC, we cultivate an inclusive culture where everyone feels valued, respected, and empowered. We welcome candidates from all backgrounds to join our team, fostering a strong sense of belonging.
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Site: www.ptcbio.com
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.
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.
Job Description:
ESSENTIAL FUNCTIONS
Primary duties/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.
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.
* Special knowledge or skills needed and/or licenses or certificates required.
- 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.
*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
Expected Base Salary Range: $127,600 - $160,600. 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. All eligible employees may also enroll in PTC’s medical, dental, vision, and retirement savings plans.
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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.
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