Senior Director of Clinical Pharmacology, Formation Bio
$311-388.5k
Offers equity
3+ days a week in office
End-to-end medical trial solutions
Open for applications
End-to-end medical trial solutions
101-200 employees
Open for applications
$311-388.5k
Offers equity
3+ days a week in office
101-200 employees
Company mission
To bring new treatments to patients faster and more efficiently.
Role
Who you are
- Proficiency in PK and PK/PD modeling software, including NONMEM, Monolix, or similar population PK tools; experience with PBPK platforms (e.g., Simcyp, GastroPlus) is a plus
- 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
Desirable
- PhD or PharmD in Clinical Pharmacology or a related field with at least 10 years of experience in the biopharmaceutical industry, and a minimum of 5 years in a supervisory role in conduct and/or oversight of clinical pharmacology
- Proven track record in leading clinical pharmacology efforts in early and late-stage drug development
- Strong understanding of regulatory requirements for clinical pharmacology studies in support of clinical development
What the job involves
- 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 early-stage drug development and contributing to business development activities across multiple modalities. 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
- 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 translational and early-stage drug development programs across multiple therapeutic areas and modalities
- 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 ADME characterization, dose selection and optimization, drug-drug interaction (DDI) studies, special population analyses (renal/hepatic impairment, pediatrics, elderly), and development of appropriate population PK (PopPK) models using tools such as NONMEM and Monolix
- Apply physiologically-based pharmacokinetic (PBPK) modeling to support dose predictions, DDI risk assessment, and labeling decisions across patient populations
- 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
- 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
- Represent Formation Bio's clinical pharmacology capabilities at scientific conferences and partner meetings
- Prepare Clinical Pharmacology sections of regulatory documents, including INDs, NDAs/BLAs, and FDA/EMA briefing documents; lead exposure-response (E-R) analyses in support of labeling; and respond to agency questions on PK/PD
Our take
Clinical drug trials are lengthy and expensive, delaying the supply of vital new drugs to patients and costing lives. For Formation Bio, this is an efficiency issue - one which it hopes to solve with its end-to-end automation solution.
According to the company, its approach has teams running medical trials twice as fast and at half the cost. This success has pushed Formation to expand beyond supporting trials into developing assets itself. In 2025, it reached a major milestone by licensing its first drug in a deal worth up to hundreds of millions. Alongside this, the company has also added an early immunology program to its pipeline, signalling a broader push into in-house development.
Now a Unicorn, with partners including Pfizer, Sanofi, Novartis and 23andMe, Formation Bio is steadily embedding itself within the Big Pharma ecosystem. How far it can go remains an open question, but the prospect of cheaper drugs and faster innovation is becoming harder for the industry to ignore.
Kirsty
Company Specialist at Welcome to the Jungle
Insights
30% employee growth in 12 months
Company
Funding (last 2 of 3 rounds)
Jun 2024
$372m
SERIES D
Sep 2021
$156m
SERIES C
Total funding: $530.3m
Company benefits
- Flexible Time Off: We have a flexible PTO policy as we trust our team members to take the time they need to recharge.
- Parental Leave: We believe your personal life enriches your professional one. We offer 16 weeks of paid parental leave for birthing parents and 12 weeks for non-birthing parents so you can start or grow your family.
- Comprehensive Benefits: All full time employees have access to health, vision, and dental insurance. Additionally, we provide pre-tax commuter benefits, access to a 401k plan, short and long-term disability and life insurance.
- Education & Career Development Resources: Formation Bio offers a plethora of professional development resources to employees. Some examples include fireside chats with industry experts, conference passes, certification courses, internal mobility opportunities, in depth manager training, leadership coaching program, and more.
- Strategic Hiring Hubs: Formation Bio teams are hybrid and based in four key hubs: New York City, Boston, the San Francisco Bay Area, and North Carolina’s Research Triangle. Our bright and collaborative NYC headquarters is conveniently located near major transit hubs and stocked with drinks, coffee, snacks, and a weekly lunch.
- Community: Our teams collaborate closely to achieve our mission, supporting each other across functions and priorities. We build connection through team-building events, quarterly company gatherings, a company-wide retreat every two years, and Employee Resource Groups.
Company values
- Think in first principles: We rigorously interrogate all possible paths to understand how we can do things differently and faster. We challenge assumptions, ask why, and solve problems from the ground up
- Be a scientist: We are curious and we continuously learn. We steelman, not strawman in debates. We listen, rapidly iterate, and make the best decisions with the evidence we have
- Deliver care: We lead with empathy. We value different perspectives, collaborate across teams, and support one another. We give and receive direct, actionable and timely feedback to hold ourselves and others to a high bar
- Champion the mission: We keep the mission as our north star and deliver impact for patients. We hold ourselves accountable for our wins and failures and keep moving forward
Company HQ
Midtown South, New York, NY
Articles
Leadership
Benjamine Liu
(Co-Founder & CEO)Worked as a computational biologist at various Neurology departments, following a D.Phil in computational Biology and Psychiatry at Oxford. They are also an Advisor at Harvard Business School.
Linhao Zhang
(Co-Founder)Linhao is also the Founder of Foundation 649. Previously, they were a Product Engineer at Oscar Insurance, a Software Engineer at Salesforce, and co-founder of Day 7 Photography.
Dan Neil
(CTO)Prior to joining Formation Bio in 2025, Dan was the Chief Data Officer at Tessera Therapeutics. Before that, they spent nearly 7 years at BenevolentAI in various roles, including SVP of AI & NY Site Lead and CTO.
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