Senior Director, Clinical Pharmacology

About Formation Bio

Formation Bio is a tech and AI driven pharma company differentiated by radically more efficient drug development.

Advancements in AI and drug discovery are creating more candidate drugs than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of new medicines that can reach patients, Formation Bio, founded in 2016 as TrialSpark Inc., has built technology platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma companies, research organizations, and biotechs to develop programs past clinical proof of concept and beyond, ultimately helping to bring new medicines to patients. The company is backed by investors across pharma and tech, including a16z, Sequoia, Sanofi, Thrive Capital, Sam Altman, John Doerr, Spark Capital, SV Angel Growth, and others.

You can read more at the following links:

• Our Vision for AI in Pharma

• Our Current Drug Portfolio

• Our Technology & Platform

At Formation Bio, our values are the driving force behind our mission to revolutionize the pharma industry. Every team and individual at the company shares these same values, and every team and individual plays a key part in our mission to bring new treatments to patients faster and more efficiently.

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.

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

About You

• 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

Formation Bio is prioritizing hiring in key hubs, primarily the New York City and Boston metro areas. These positions will follow a hybrid work model with 1-3 days required at the office. Applicants from the Research Triangle (NC) and San Francisco Bay Area may also be considered. Please only apply if you reside in these locations or are willing to relocate.

Compensation:

The target salary range for this role is: $318,000 - $400,000

Salary ranges are informed by a number of factors including geographic location. The range provided includes base salary only. In addition to base salary, we offer equity, comprehensive benefits, generous perks, hybrid flexibility, and more. If this range doesn't match your expectations, please still apply because we may have something else for you.

You will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.