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.
Job Description:ESSENTIAL FUNCTIONSPrimary 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
*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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