Senior Director, CMC Team Leader

About the role

The Scientific Director, CMC Team Leader is responsible for developing and leading the execution of comprehensive, compound-specific CMC strategies to meet global R&D project needs. Supporting the Product Development portfolio, which includes small molecules, large molecules and new modalities (conjugates, peptides and oligonucleotides), this unique role is critical to our role turning molecules into medicines.

Responsibilities

• Leads the interdisciplinary matrix teams responsible for developing and executing compound-specific integrated CMC strategies that advance R&D Project Team objectives and encompass drug substance, drug product, analytical, quality, regulatory, and clinical supplies.
• Represents the Global Product Development and Supply (GPS) organization on key R&D Project Teams, actively collaborates across functional areas (Clinical, Commercial, Regulatory, Clinical Pharmacology, Toxicology, etc.) and influences the BMS organization to develop globally optimized program strategies.
• Communicates and partners effectively across functional areas within Product Development and other stakeholders (Quality, Toxicology, DMPK, Clinical Pharmacology, Regulatory CMC, Commercial Manufacturing, etc.) to define and execute the CMC strategy for the project.
• Identifies and escalates key issues, risks and resource allocation needs, as appropriate.
• Accountable for managing multiple assets across large and small molecules, ranging across phases of development from candidate nomination, First-in-Human, and pivotal clinical studies, through to market application approvals (BLA, NDA) in partnership with CMC Team Project Manager.
• Accountable for CMC Project budget and applies financial acumen to evaluate portfolio trends and anticipate the impact of strategic inflection points on project trajectories.
• Works with a ‘return on investment’ mindset to define project opportunities, seeking to optimize PDs impact within the broader portfolio.
• Influences CMC regulatory strategies and critically reviews relevant documents, including but not limited to all CMC regulatory submissions, briefing booklets, and information requests.
• Champions operational excellence by driving the adoption of best practices and spearheading strategic improvement initiatives, including the adoption of advanced digital capabilities, planning tools and program simulation.
• Promotes operational excellence by driving the adoption of best practices and spearheading strategic improvement initiatives, including the adoption of advanced digital capabilities, planning tools and program simulation.
• Partners with the GPS Business Development group to support Due Diligence evaluations and activities to bring assets into the GPS network and partner with alliance management, as necessary.

Qualifications

• Advanced degree in relevant scientific discipline
• 15+ years of relevant CMC experience in the pharmaceutical industry
• Robust understanding of how CMC integrates and partners with Non-Clinical and Clinical development, Quality, Regulatory, Commercial and other functional areas in pharmaceutical development
• Capable of thinking critically and developing strategic plans that align with long-term business objectives and drive innovation
• Excellent verbal and written communication, as well as strong problem-solving, and decision-making skills
• Proven track record of influencing and building strong partnerships with diverse stakeholders across the organization to achieve strategic goals
• Keen sense for value of investment with a proven track record of applying risk-balanced and differential investment principles to enhance CMC operations and drive organizational success
• Demonstrated ability to lead, inspire, and develop high-performing teams while fostering a collaborative and inclusive team culture
• Ability to manage ambiguity and make decisions with limited information, when required
• Experience in multiple modalities (e.g., biologics, small molecules, antibody-drug conjugates) is a clear plus
• Broad and deep understanding of chemical and/or biological, formulation and analytical development and a proven track record of leading CMC teams throughout the development lifecycle, from early-stage development through commercialization
• Experience in multiple modalities (e.g., biologics, small molecules, antibody-drug conjugates) is a clear plus
• Relevant strategic and tactical project leadership experience, ability to lead empowered, highly collaborative matrix teams with shared vision, value, and purpose

Skills

• Senior Director: Advanced degree in relevant scientific discipline, 15+ years of relevant CMC experience in the pharmaceutical industry, robust understanding of how CMC integrates and partners with Non-Clinical and Clinical development, Quality, Regulatory, Commercial and other functional areas in pharmaceutical development, capable of thinking critically and developing strategic plans that align with long-term business objectives and drive innovation, excellent verbal and written communication, as well as strong problem-solving, and decision-making skills, proven track record of influencing and building strong partnerships with diverse stakeholders across the organization to achieve strategic goals, keen sense for value of investment with a proven track record of applying risk-balanced and differential investment principles to enhance CMC operations and drive organizational success, demonstrated ability to lead, inspire, and develop high-performing teams while fostering a collaborative and inclusive team culture, ability to manage ambiguity and make decisions with limited information, when required, experience in multiple modalities (e.g., biologics, small molecules, antibody-drug conjugates) is a clear plus, broad and deep understanding of chemical and/or biological, formulation and analytical development and a proven track record in CMC development and/or leading CMC teams throughout the development lifecycle, from early-stage development through commercialization
• Director: Advanced degree in relevant scientific discipline, 12+ years of relevant CMC experience in the pharmaceutical industry, solid understanding of how CMC integrates and partners with Non-Clinical and Clinical development, Quality, Regulatory, Commercial and other functional areas in pharmaceutical development, exceptional verbal and written communication skills with a proven ability to influence and align stakeholders across all levels and functions within a complex matrix environment, including both internal and external partners, keen sense for value and understanding of investment strategy, ability to apply risk-balanced and differential investment principles to enhance CMC operations and drive organizational success, capable of thinking critically and developing strategic plans that align with long-term business objectives and drive innovation, ability to manage ambiguity and make decisions with limited information, when required, demonstrated ability to operate as an enterprise leader, driving clarity and influence to advance business objectives, broad understanding of chemical and/or biological, formulation and analytical development and a proven track record in CMC development and/or leading CMC teams throughout the development lifecycle, from early-stage development through commercialization, experience in multiple modalities (e.g., biologics, small molecules, antibody-drug conjugates) is a clear plus, relevant strategic and tactical project leadership experience, ability to lead empowered, highly collaborative matrix teams with shared vision, value, and purpose, demonstrated ability to lead, inspire, and develop high-performing teams while fostering a collaborative and inclusive team culture, ability to manage ambiguity and make decisions with limited information, when required, experience in multiple modalities (e.g., biologics, small molecules, antibody-drug conjugates) is a clear plus, strong knowledge of global regulatory guidelines and requirements (e.g., FDA, EMA, ICH guidelines)

Benefits

Our benefits include:

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
• Work-life Benefits Include Paid Time Off