TrialSpark

Title: General Manager (Drug Asset Lead) Location: New York, NY; Boston, MA 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, 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: As General Manager for a Formation Bio asset, you will be the accountable leader —responsible for translating the investment thesis into action and progressing the asset towards value inflection with speed, efficiency, and leverage. You will own the asset strategy, budget, and execution rhythm, ensuring momentum, clarity, and disciplined delivery across functions. GMs at Formation Bio own outcomes: they make high-stakes decisions (including no-go calls), anticipate inflection points, and deploy resources to maximize value. You will align financial and operational decisions with the asset strategy and work in close partnership with a Clinical Lead and other cross functional partners and stakeholders to advance the asset with scientific rigor, operational excellence, and AI-enabled leverage. Responsibilities - Refine and deliver the strategy for the asset and define key results that ladder up to asset objectives. - Drive and own business outcomes—including asset P&L, budgets, ROI, and value inflection with speed. - Lead a team of full-time and contract team members, forecasting and pulling resources (functional experts, tech, and other services) as needed. - Partner with the assigned Tech Lead, Clinical Development Lead, and other functional subject matter experts (e.g., CMC, Regulatory, Data Science) to drive asset strategy and execution. - Establish and run team rituals (charters, prioritization touchpoints, etc.) that ensure clarity, accountability, and disciplined execution. - Anticipate and surface tradeoffs, risks, and governance needs, while maintaining autonomy for operational decisions. - Develop and maintain comprehensive governance tools such as asset development roadmaps, registers and dashboards. - Track and manage against success metrics, including milestone adherence, team efficiency and overall asset value. - Provide ongoing strategic updates to the Formation Bio Leadership Team, ensuring alignment with broader portfolio and company-level strategy. About You - Outcome-Driven: You optimize for value creation and speed, not process for its own sake. - Radically Accountable: You own timelines, budgets, risks, and tradeoffs without relying on matrix ambiguity. - AI-Native: You naturally embed AI and automation into team culture, workflows, and decisions. - Generalist With Range: You flex across disciplines, knowing when to go deep or bring in expertise and when to rely on the team. - Influential Without Authority: You earn trust and alignment among SMEs and functional leaders without direct reporting lines. - Structured & Decisive: You run the team like a business—with sharp prioritization, clear charters, and disciplined execution. - Comfortable in Ambiguity: You thrive in dynamic environments, simplify complexity, and adapt quickly. - Strategically grounded with tactical depth: You seamlessly connect high-level vision to detailed, practical action. Total Compensation Range: $311,000 - $388,500 Compensation Individual compensation is determined by several factors, including role scope, geographic location, and skills & experience. Your offer will reflect where you fall within the range based on these considerations. In addition to base salary, we offer equity, comprehensive benefits, and generous perks. If the posted range doesn't match your expectations, we still encourage you to apply! Where We Hire Formation Bio is prioritizing hiring in key hubs, primarily the New York City and Boston metro areas, with a hybrid model requiring 3 days per week in office. Applicants from the Research Triangle (NC) and San Francisco Bay Area may also be considered. Please apply only if you reside in these locations or are willing to relocate. Equal Opportunity Formation Bio is committed to building a diverse and inclusive team. We are an equal opportunity employer and welcome candidates from all backgrounds. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, ancestry, sex (including pregnancy, childbirth, breastfeeding, and related medical conditions), gender identity or expression, sexual orientation, age, disability, genetic information, marital status, military or veteran status, or any other characteristic protected by federal, state, or local law.

Title: Associate Director, Program Management - Asset Diligence & Integration Locations: New York City and Boston / Research Triangle (NC) and San Francisc hybrid 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. About the Position Formation Bio is seeking an Associate Director, Program Management - Asset Diligence & Integration to partner with our Business Development (BD) and cross-functional teams across the end-to-end asset diligence lifecycle-from initial screen through confirmatory diligence and integration. This role will lead late-stage diligence efforts, support asset onboarding post-acquisition, and help build scalable program management infrastructure that enhances execution, visibility, and governance. Depending on portfolio needs, you may also flex into post-acquisition program management, driving near-term development milestones until steady-state ownership is established. Key Responsibilities Diligence Program Management - Lead and manage the full diligence process from initial evaluation to pre-close. - Coordinate cross-functional workstreams (Clinical, CMC, Regulatory, Nonclinical, QA, Commercial, Finance, Legal/IP). - Maintain trackers, RAID logs, and timelines; deliver leadership updates and red-flag summaries. - Orchestrate expert calls, debriefs, and management meetings, capturing insights and follow-ups. Confirmatory Diligence Leadership - Drive scientific, technical, and commercial deep dives across functions. - Lead scenario planning for timelines, costs, and resources; partner with Finance to assess trade-offs and business impact. Prepare executive-ready Go/No-Go materials outlining risks, mitigations, and term-sheet implications. Program Management Infrastructure & Process Optimization - Build and refine playbooks, templates, and decision-making frameworks for diligence and integration. - Enhance Smartsheet-based dashboards, workflows, and reporting tools for portfolio governance. - Identify and implement AI and automation tools to streamline workflows and accelerate decision-making. - Drive cross-functional planning, risk management, and clear action tracking. Flex Capacity (Post-Acquisition Support) - Support early-stage execution for newly acquired assets, coordinating integrated development plans until long-term teams are established. About You - A builder who designs fit-for-purpose processes and scales operational excellence. - Equally strong in strategic thinking and hands-on execution, with clear, concise communication at all levels. - Thrive in high-growth, high-ambiguity environments and drive alignment and momentum. - Curious about and eager to leverage AI and automation to improve PM efficiency and derive insights. Qualifications - 6+ years in program or project management within the life science, biotech, or pharmaceutical industry. - Bachelor's degree in life sciences (e.g., Biology Chemistry, Pharmacology), Health Sciences or Public Health, Engineering (e.g., biomedical, chemical, systems), Business Administration, or Management with strong healthcare/biotech context. Advanced degree preferred, in fields that bridge science and business, or certification in Smartsheet or Project management (e.g., PMP, CAPM, CSM, Lean Six Sigma). - Proven ability to integrate cross-functional inputs into actionable, business-driven plans. - Strong stakeholder management and influencing skills in a matrixed organization. - Proficiency with Smartsheet (certification or willingness to obtain) and advanced Excel/Google Sheets modeling. - Experience in Inflammation & Immunology, CNS, Cardiovascular/Metabolic, or Dermatology preferred. - Familiarity with term sheets, diligence workplans, asset integration, and regulatory/quality transitions a plus. Formation Bio is prioritizing hiring in key hubs, primarily the New York City and Boston metro areas, with additional growth in the Research Triangle (NC) and San Francisco Bay Area. Please only apply if you reside in these locations or are willing to relocate. Compensation: The target salary range for this role is: $168,000 - $210,000. 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. #LI-hybrid

Title: Associate Director, GMP QA Locations: Boston, MA; New York, NY; Raleigh-Durham, NC; San Francisco, CA Hybrid 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. 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 The Associate Director, GMP Quality Assurance is responsible for ensuring that all GMP-regulated activities, including manufacturing, testing, packaging, labeling, storage, and distribution of Formation Bio's portfolio are executed in compliance with regulatory requirements, industry standards, and company procedures. This role supports CMC development activities, audits CDMOs, conducts batch release, and performs investigations. The ideal candidate is a hands-on quality champion with strong communication skills and the ability to pivot in a dynamic environment. Additionally, the role explores opportunities to integrate artificial intelligence (AI) technologies to improve efficiency, compliance, and overall quality assurance practices. Responsibilities ● Ensure compliance with global regulations (e.g., FDA, EMA, ICH) and internal SOPs, Policies and Work Instructions ● Review and approve GMP documents, including SOPs, master batch records, specifications, protocols, and reports ● Perform QA review of executed batch records, supporting manufacturing documents, and testing results to support timely and compliant batch disposition ● Support investigations into deviations, OOS/OOT results, environmental monitoring excursions, and quality events ● Conduct internal audits to assess compliance and identify improvement opportunities ● Conduct the qualification and periodic assessment of suppliers, CDMOs, laboratories, and service providers ● Review and maintain Quality Agreements, ensuring external partners meet GMP expectations ● Support preparation for and participation in regulatory inspections and due diligence audits ● Apply risk management principles (e.g., FMEA) to guide decision-making ● Champion a culture of quality, transparency, and continuous improvement About You ● Bachelor's degree in scientific discipline (e.g., Chemistry, Biology, Engineering, Pharmaceutical Sciences) ● 8+ years experience in GMP Quality Assurance within pharmaceutical, biologics, or biotechnology manufacturing and testing ● Deep understanding of GMP expectations (e.g., FDA, EMA, and ICH) and a commitment to patient safety ● Excellent communication, organization, and collaboration skills ● Ensures accuracy and completeness in documentation and decision-making ● Ability to lead investigations and write clear, concise supporting documents ● Experience with CMO oversight or virtual manufacturing models ● Thrive in a dynamic, fast-paced environment with evolving priorities Formation Bio is prioritizing hiring in key hubs, primarily the New York City and Boston metro areas, with additional growth in the Research Triangle (NC) and San Francisco Bay Area. Please only apply if you reside in these locations or are willing to relocate. Compensation: The target salary range for this role is: $169,000 - $200,000 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.