Senior Director, Clinical Pharmacology
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Senior Director, Clinical Pharmacology
ptcbio· PTC Therapeutics, Inc.
About this 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.
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.
Visit our website to learn more about our company and culture!
Site: www.ptcbio.com
Job Description Summary:
The Senior Director, Clinical Pharmacology is responsible for providing hands-on support for Clinical Pharmacology to PTC’s Clinical Development function. This includes performing, coordinating, and overseeing PK & PK/PD assessment(s) in patients; interpreting data; and providing timely Clinical Pharmacology-related support to various functions, including, but not limited to, clinical, biostatistics, medical writing, regulatory, commercial, toxicology, preclinical pharmacology, discovery research as well as external Contract Research Organizations (CROs). The incumbent is also responsible for providing project management support for select projects in clinical development, including the delivery of all relevant clinical pharmacology studies.The incumbent works cross-functionally with internal departments and external resources in PTC’s program teams.
The Senior Director, Clinical Pharmacology may manage direct reports.
The Senior Director, Clinical Pharmacology ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
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Job Description:
ESSENTIAL FUNCTIONS
Primary duties/responsibilities:
Establishes Clinical Pharmacology strategies that align with team goals and meet regulatory requirements (IND and NDA etc.).
Acts as the lead clinical pharmacologist for clinical stage programs; designs, conducts, and manages assigned clinical pharmacology (PK, PK/PD, PBPK, popPK, DDI, FE, and PK in special populations) and relevant DMPK studies and performs hands-on data interpretation.
Represents clinical pharmacology on multidisciplinary projects and provides scientific leadership and strategic direction to clinical programs.
Serves as the subject matter expert for clinical pharmacology in the development teams, including FIH by conducting human PK parameters and exposure projection using in vitro and animal PK data, estimating MRSD, designing optimal dose-finding strategy.
Develops and writes relevant documents including IB, protocols, study reports, IND/NDA, eCTDs, regulatory documents as appropriate in close partnership with clinical operation, medical, regulatory, biostatistics, and medical writing.
Collaborates closely with the functional groups within clinical pharmacology & DMPK and other stakeholders.
Effectively communicates clinical pharmacology & DMPK-related data and their relevance to multidisciplinary project teams, management, and regulatory authorities.
Ensures the scientific quality of clinical pharmacology data in support of development program.
Identifies and manages collaboration with external CROs in PK, PK/PD, and E/R analysis.
Performs other tasks and assignments as needed and specified by management.
May manage, coach, and/or mentor direct reports or junior clinical pharmacologists.
KNOWLEDGE/SKILLS/ABILITIES REQUIRED
* Minimum level of education and years of relevant work experience.
Ph.D., Pharm.D. or equivalent academic training in pharmacokinetics, pharmaceutical sciences or a related discipline and a minimum of 9 years of relevant and progressively responsible experience in clinical pharmacology including extensive experience in DMPK in a pharmaceutical, biotechnology or related environment OR equivalent experience and/or education.
* Special knowledge or skills needed and/or licenses or certificates required.
Broad understanding of clinical pharmacology & DMPK relevant areas such as PK assessment in patients, exposure-responses relationship analysis, PK modeling, DDI, physicochemical properties, drug metabolizing enzyme & transporter kinetics, pharmacokinetics, mechanistic biotransformation, and analytical sciences.
Proficiency in NCA PK (WinNonlin) and hands-on experience in PBPK and popPK modeling
Leads clinical pharmacology strategy and communicates data-driven recommendations effectively to both technical and non-technical stakeholders.
Experience in managing projects.
A strong understanding of regulatory guidelines for clinical pharmacology & DMPK packages to support drug development.
Ability to work with sometimes conflicting priority settings to adhere to project and team timelines.
Demonstrated experience writing study reports and regulatory documents.
Demonstrated leadership ability.
Ability to influence without direct authority.
Excellent verbal and written communication skills.
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 planning, organization and time management skills including the ability to support and prioritize multiple projects.
*Special knowledge or skills and/or licenses or certificates preferred.
Proficient people and project management experience.
* Travel requirements
Up to 10%
*Physical requirements
Office/Laboratory based position
Expected Base Salary Range: $237,400 - $298,900. The base salary offered will be contingent on assessment of candidate 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.
Frequently Asked Questions
What is the salary for the Senior Director, Clinical Pharmacology role at ptcbio?
The listed salary for this Senior Director, Clinical Pharmacology position at ptcbio is USD 237K–299K. This is an Full time role.
Where is the Senior Director, Clinical Pharmacology position at ptcbio located?
This Senior Director, Clinical Pharmacology role at ptcbio is based in USA - New Jersey - Warren. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Is the Senior Director, Clinical Pharmacology role at ptcbio full-time or part-time?
This is listed as a Full time position. It is posted as a Senior Director, Clinical Pharmacology role in the PTC Therapeutics, Inc. department at ptcbio.
Which team or department does the Senior Director, Clinical Pharmacology at ptcbio belong to?
This Senior Director, Clinical Pharmacology position is part of the PTC Therapeutics, Inc. department at ptcbio. See the full job description for more information about the team structure and responsibilities.
How do I apply for the Senior Director, Clinical Pharmacology position at ptcbio?
Click the "Apply Now" button on this page. You will be redirected to ptcbio's official application portal hosted on workday where you can submit your application directly.
Senior Director, Clinical Pharmacology
ptcbio · 💰 USD 237K–299K
You'll be redirected to ptcbio's official application page on Workday.