Job Description
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.
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 The Director of Clinical Project Management will provide overall leadership and strategic direction for the clinical project management functions in a technology-driven, AI-focused biotech environment. This individual will be responsible for leading multiple clinical programs across various therapeutic areas and phases (I-IV), ensuring compliance with global regulations, delivering on timelines and budgets, and driving a culture that leverages technology and AI platforms to enhance efficiency and scalability.
Responsibilities - Project Management Oversight
- Provide strategic and tactical guidance for multiple concurrent clinical studies, ensuring alignment with corporate goals, timelines, and budget parameters.
- Maintain accountability for project deliverables, including overall timelines, budget forecasts, and resource allocation.
- Ensure all clinical trials comply with ICH-GCP, FDA regulations, and other applicable regulatory standards.
- Champion proactive risk management by identifying and mitigating risks before they escalate.
- Oversee vendor relationships and governance, holding external partners to high standards of quality, cost control, and on-time deliverables.
- Serve as the Operations Lead for clinical assets, programs, and studies. Step in as the Clinical Project Manager when needs arise.
- Operational Strategy and Leadership
- Develop and implement operational strategies for programs and clinical studies.
- Collaborate with cross-functional teams (Clinical Development, Regulatory, Program Management, etc.) to shape and refine Strategic Development Plans and Clinical Development Plans, ensuring feasibility and operational excellence.
- Support protocol development and development of essential documents (e.g., Investigator's Brochures, informed consent forms) by providing critical operational insights.
- Remain current on emerging industry trends, regulatory updates, and best practices, pivoting operational strategies to maintain competitive advantage.
- AI and Technology Enablement
- Leverage AI-powered tools and technology platforms to streamline clinical processes.
- Champion a "tech-first, headcount-second" approach to scale programs and teams efficiently, reducing human error, accelerating timelines, and improving data quality.
- Collaborate with internal and external tech partners to evaluate and implement cutting-edge solutions, ensuring organizational readiness and training for seamless adoption.
About You - Bachelor's degree in life sciences, nursing, pharmacy, or a related field (advanced degree preferred).
- Minimum of 10 years of clinical project management/clinical operations experience, including at least 5 years in a leadership capacity.
- Proven track record in managing complex global trials across multiple phases (I-IV) and therapeutic areas.
- Experience working within a sponsor company.
- Experience in the integrated in house clinical trial execution model.
- Experience working with CROs and managing complex, multi-center clinical trials.
- In-depth knowledge of ICH-GCP, FDA regulations, and global clinical trial guidelines.
- Strong strategic thinking and analytical skills.
- Proven ability to lead and develop high-performing teams in a fast-paced, dynamic environment.
- Strong project management skills, with the ability to manage multiple priorities and meet tight deadlines.
- Excellent communication, interpersonal, and problem-solving skills.
- Ability to travel as required (up to 25%).
- Preferred: Advanced degree (e.g., MSc, PhD, MBA) in a related field.
Formation Bio is headquartered in New York City, with plans to build a larger team and presence in Boston. We are prioritizing hiring in these areas, with an expectation for NYC-based employees to work in the office at least two days per week. While our primary focus is on candidates in NYC (including the Tri-state Area) and Boston, we may consider remote candidates from specific geographies based on qualifications, skills, and business needs. We believe that in-person collaboration is essential for breaking down silos, fostering cross-functional teamwork, and embedding our company values into daily work. All employees located outside of the NYC Metro Area will be expected to travel to the NYC office at least four times per year for company events and team-specific meetings or activities.
Compensation: Salary ranges are informed in part by geographic location, in addition to other factors. The target salary ranges for this role are:
- NYC Metro Area, Boston Metro Area, SF Bay Area : $200,000 - $250,000
- All Other Eligible Remote Locations : $190,000 - $238,000
The ranges provided above include base salary only. In addition to base salary, we offer equity, generous perks, hybrid flexibility, and comprehensive benefits.
If this range doesn't match your expectations, please still apply because we may have something else for you.
**
Eligible Remote Locations (if applicable): Alabama (AL), Arizona (AZ), California (CA), Connecticut (CT), Florida (FL), Georgia (GA), Illinois (IL), Indiana (IN), Maryland (MD), Massachusetts (MA), New Hampshire (NH), New Jersey (NJ), North Carolina (NC), Ohio (OH), Pennsylvania (PA), South Carolina (SC), Texas (TX), Utah (UT), Virginia (VA), and Washington, D.C. (DC).
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.
#LI-hybrid
Job Tags
Remote job, 2 days per week,