Senior Director, Clinical Pharmacology
About The Position
Formation Bio is seeking an experienced and innovative Senior Director of Clinical Pharmacology to join our Development team. In this role, you will lead our clinical pharmacology efforts, supporting late-stage drug development and contributing to business development activities. You will play a crucial role in advancing our mission to bring new treatments to patients faster and more efficiently through our innovative, tech-enabled drug development platform. The role reports to the VP of Translational Medicine and you will be a key member of the Formation Bio Development team.
Requirements
- PhD or PharmD in Clinical Pharmacology or a related field with at least 15 years of experience in the biopharmaceutical industry, and a minimum of 10 years in a supervisory role in conduct and/or oversight of clinical pharmacology
- Proven track record in leading clinical pharmacology efforts in late-stage drug development
- Strong understanding of regulatory requirements for clinical pharmacology studies in support of clinical development
- Competent in the use of PK and PK/PD modeling software tools
- Experience in due diligence activities for in-licensing opportunities
- Excellent communication and leadership skills
- Ability to work effectively in a fast-paced, cross-functional environment
- Innovative mindset and enthusiasm for leveraging technology in drug development
Responsibilities
- Develop clinical pharmacology strategy consistent with the target product profile, program goals and regulatory strategy
- In collaboration with the Clinical Development team, define biopharmaceutics and clinical pharmacology studies needed to support NDA and drug label
- Lead clinical pharmacology activities in supporting late-stage drug development programs across multiple therapeutic areas
- Design and oversee the execution of clinical pharmacology studies to support clinical development and regulatory submissions
- Determine scope, design, plan and analyze Phase 1-IV PK and PD studies, including development of appropriate population PK models.
- Contribute clinical pharmacology expertise to due diligence efforts for potential in-licensing opportunities
- Serve as the primary Clin Pharm lead and effectively participate in cross-functional teams to ensure integration of modern clinical pharmacology principles into project plan and study design integrated development strategies
- Provide scientific leadership in interactions with regulatory agencies and external partners
- Develop and implement innovative approaches to enhance the efficiency and effectiveness of clinical pharmacology studies
- Manage resources, timelines, and budget for clinical pharmacology activities
- Mentor and develop the clinical pharmacology team, fostering a culture of scientific excellence and innovation
- Represent Formation Bio's clinical pharmacology capabilities at scientific conferences and partner meetings
- Prepare Clinical Pharmacology Section of regulatory documents, including INDs, NDAs, and briefing documents
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
Number of Employees
101-250 employees
