Director, Clinical Pharmacology

The Director of Clinical Pharmacology will lead the development and implementation of clinical pharmacology strategies for small molecules and biologics within the company's portfolio. They will offer expertise in analyzing pharmacokinetics, absorption, distribution, elimination profiles, dose selection rationale, drug/food interaction potential, and QT prolongation potential. Collaboration with key functions like Clinical Development, Biometrics, Biomarkers, Regulatory, and CMC will be essential. Responsibilities will involve planning and evaluating study designs and analysis plans, interpreting pharmacokinetic and pharmacodynamic data, and preparing and supporting the Clinical Pharmacology sections of regulatory submissions.

Essential Functions Of The Job

• Lead clinical pharmacology activities on project teams
• Develop and execute clinical pharmacology and pharmacometrics strategies to mitigate risks and support development of small molecule and/or biologics drug candidates from pre-IND and first-in- human testing through all phases of clinical development.
• Collaborate with preclinical scientists to provide support for translational studies.
• Author high quality documents and review relevant clinical sections for IND and other regulatory submissions.
• Develop clinical pharmacology study designs and collaborate with CROs and Clinical Operations to write study protocols, amendments, and reports, ensuring that designs and documents meet global regulatory and compliance requirements and project timelines.
• Contribute to the design and analysis of PK data from patient clinical studies.
• Conduct hands-on clinical PK, pharmacometrics data analysis.
• Analyze, interpret, summarize, and present data to internal project teams, senior management, and to global health authorities.
• Discuss clinical pharmacology plans to support development and filings with health authorities.
• Author, review, and finalize relevant sections of global regulatory documents, which may include IND/CTA filings as well as NDA/MAA/BLA submissions and respond to health authority questions related to these submissions.
• Provide clinical pharmacology reviews on business diligence activities.

Supervisory Responsibilities

• Potential to direct management or mentoring junior members of the group as needed
• Manage clinical pharmacology vendors, consultants for specific project needs

Computer Skills: Hands-on experience in performing NCA is desired as well as ability to perform some exploratory programming

Other Qualifications: A Ph.D. or equivalent in Pharmacokinetics, Pharmaceutical Sciences, Biomedical Engineering or related discipline with at least six years of industry and/or related post- doctoral experience is preferred. Demonstrable scientific, clinical development and regulatory experience based on prior experience with NDA/BLA/MAA filings and/or publications is essential. Familiarity with DMPK studies, bioanalytical methods is preferred. Prior experience in biologics is desired.

Travel: Ability to travel to manage clinical pharmacology collaborations and to health authority interactions. 

Skills and Attributes:

• Ability to understand scientific and health principles related to product development and regulations.
• Attention to detail, business and financial acumen
• Excellent time management and organizational skills
• Proven ability to manage multiple tasks and associated deadlines in a pro-active manner
• Exceptional communication and interpersonal skills
• Strong computer literacy
• Flexibility to adapt in a cross-functional and dynamic, “start-up” type environment, eager to participate and contribute

Equal Opportunity Employer