Senior Director, CMC Leadership & Diligence, Early Asset Leadership and Evaluation
Bristol-Myers Squibb (BMS) · 2 Locations
Job description
At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it. Position: Senior Director, CMC Diligence & Leadership Direct Manager: Executive Director, Early Asset Evaluation & Development Division: Product Development and Supply (PDS), Product Development Location: New Brunswick or Princeton, NJ Job Description: The Senior Director, CMC Diligence & Leadership, within Early Asset Evaluation & Development, is PDS's lead scientific and technical voice in shaping which assets BMS brings in-house and how they are successfully developed after transaction close. This role owns the CMC diligence strategy for in-licensing, alliance, and M&A opportunities across small molecules, biologics, and novel modalities including conjugates, peptides, oligonucleotides, driving deal evaluation, negotiation support, and risk assessment in close partnership with Corporate and PDS Business Development. Once assets are secured, the same leader carries that strategic ownership forward, leading matrixed CMC teams to execute integrated development strategies and representing PDS in front of governance and senior executive audiences. This role requires equal comfort navigating detailed technical discussions and presenting strategic direction to the C-suite. Responsibilities include: Business Development & Diligence Leadership Own the CMC diligence strategy for in-licensing, alliance, and M&A opportunities, serving as the scientific single point of contact for PDS with Corporate Business Development across the full deal lifecycle. Lead cross-functional diligence teams to evaluate drug substance, drug product, analytical, quality, clinical supply, and regulatory readiness of prospective assets, identifying technical risks and value creation opportunities. Drive and shape deal negotiations and contracting for PDS-related terms, partnering directly with Business Development, Legal, and Finance to structure agreements that protect BMS' technical and commercial interests. Lead generation of Cost of Goods (COGs) estimates and financial-flow modeling with PDS Finance, enabling rigorous financial evaluation of assets and informing deal structure and pricing. Build and present due diligence findings, valuations, and contingency/risk-mitigation plans to PDS and enterprise leadership to secure investment approvals and go/no-go decisions. Make and defend timely, well-reasoned CMC recommendations during diligence windows where the target's data package is partial or incomplete, applying sound scientific judgment to fill gaps and clearly flagging residual risk and its potential deal impact. Facilitate integration of newly acquired or partnered assets into R&D and PDS post-transaction, ensuring diligence insights translate into executable development plans. CMC Strategy Leadership Lead interdisciplinary matrix teams to develop and execute compound-specific integrated CMC strategies encompassing drug substance, drug product, analytical, quality, regulatory, and clinical supplies. Partner, negotiate and communicate effectively across Product Development and other functional areas — Quality, Toxicology, DMPK, Clinical Pharmacology, Regulatory CMC, Commercial Manufacturing — to define and execute CMC strategy, identifying and escalating key issues, risks, and resource needs. Accountable for leading multiple assets agnostic of modality, spanning phases of development from candidate nomination and First-in-Human through pivotal studies and market application (BLA, NDA), ensuring adequate knowledge transfer and transition planning into BMS. Influence CMC regulatory strategy and critically review CMC regulatory submissions, briefing documents, and health authority information requests. Champion operational excellence by driving adoption of best practices and strategic improvement initiatives, including advanced digital capabilities, planning tools, and program simulation. Executive & Governance Communication Serve as a trusted, credible voice with senior executives and cross-functional leadership, translating complex CMC strategy and/or diligence findings into clear, decision-ready recommendations. Prepare and deliver compelling presentations to joint governance committees, global project teams (GPT), alliance leadership, and senior-level stakeholders, framing technical risk and opportunity in business terms. Build alignment and influence outcomes across multiple internal and external stakeholders in high stakes, ambiguous, and time-pressured governance settings. Construct and defend well-reasoned, risk-adjusted recommendations for senior executive audiences even when the underlying diligence data set is incomplete, distinguishing what is known, what is assumed, and what remains a genuine risk. Financial & Strategic Impact Drive CMC project budget and apply financial acumen to evaluate portfolio trends, anticipating strategic inflection points with a return-on-investment mindset. Apply cost-of-goods, capacity, and investment analysis to shape sourcing decisions across the portfolio, ensuring capital and resourcing are directed to the highest-value opportunities. Translate CMC cost, risk, and capability trade-offs into strategic recommendations that inform portfolio prioritization and long-range investment planning across Product Development. Minimum Qualifications: Advanced degree in chemistry, biochemical/chemical engineering, or related science; PhD preferred, with 15+ years in the biopharmaceutical industry. Substantial business development and alliance management experience, including deal diligence, negotiation support, and cross-functional deal-team leadership. Strong knowledge of Biologics Drug Substance (BDS), API, and/or Drug Product development and manufacturing, with experience across multiple modalities (biologics, small molecules, ADCs). Proven track record leading CMC teams and evaluating external assets throughout the development lifecycle, from early stage through commercialization, including experience with CMOs and complex supply chains. Exceptional executive presence and communication skills, with demonstrated ability to present technical and financial recommendations persuasively to senior executives and governance committees. Solid understanding of how CMC integrates with Regulatory, Quality, Clinical, Manufacturing, and Commercial functions, along with global regulatory guidelines (FDA, EMA, ICH). Proven ability to make and stand behind sound scientific and business decisions with limited or incomplete information — a core, frequent demand of diligence work — constructing recommendations that are rigorous and defensible even under time pressure and data gaps. Acts with the highest level of integrity and full appreciation of confidentiality requirements. Highly motivated, results-focused, and able to travel up to 10% domestically or internationally. We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway. Compensation Overview: New Brunswick - NJ - US: $234,100 - $283,672 Princeton - NJ - US: $234,100 - $283,672 The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by
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