Senior Director, Clinical Pharmacology

Formation Bio•Boston, MA

1d•$318,000 - $400,000•Hybrid

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