Senior Director, CMC Diligence & Strategy

Bristol Myers Squibb; New Brunswick (NJ); Hybrid; USD 234,000 - 284,000; Full time

Job summary

Bris tol Myers Squibb seeks a Senior Director, CMC Diligence & Leadership, to lead CMC diligence strategy and oversee cross-functional teams across small molecules, biologics, and novel modalities. You will shape deal evaluations, provide governance-ready recommendations, and partner with Corporate Development to drive value.

In this role, you will present findings to senior leadership, guide risk mitigation, and integrate newly acquired assets into R&D.

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 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.

Responsibilities

• 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.
• 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.
• 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.
• 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.

Skills

Business development

Alliance management

Cross-functional leadership

Executive communication

Education

PhD in chemistry/biochemical engineering

Job description

Bris tol Myers Squibb seeks a Senior Director, CMC Diligence & Leadership, to lead CMC diligence strategy and oversee cross-functional teams across small molecules, biologics, and novel modalities. You will shape deal evaluations, provide governance-ready recommendations, and partner with Corporate Development to drive value.

In this role, you will present findings to senior leadership, guide risk mitigation, and integrate newly acquired assets into R&D.