Senior Director, Analytical Development (R1557929-en-us)
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
The Senior Director will lead and provide strategic direction for the analytical team leads (ATLs) within Pharmaceutical Development for support of small molecule drug candidates across all stages of development and, as needed, within our commercial product portfolio for life cycle management or knowledge transfer.
The incumbent will be proficient in the latest FDA and EMA regulatory guidances on pharmaceutical development. The Senior Director will have direct impact on the division and also influence in the broader BMS community via implementation of analytical cross-functional work processes and initiatives. The successful candidate will be a leader in the PD analytical community both inside and outside of BMS.
The Senior Director will primarily be leader of leaders within matrix team of analytical scientists, and a core member on the ASO extended leadership team. The Senior Director will collaborate across BMS sites with functional Analytical Leads, Drug Substance and Drug Product Leads, Quality Leads, and Regulatory Leads to generate and execute analytical strategies for methods and specifications, analytical control strategies, and support of product development up to drug application submissions
- Direct management of personnel including performance appraisals, promotions, salary administration, staff hiring, mentoring, and other personnel related activities
- Experienced leadership in supervision of scientific staff. Able to develop, coach and mentor others.
- May serve on cross functional teams responsible for analytical related CMC strategy development.
- Review and discuss analytical results and conclusions both orally and in writing.
- Write/approve formal reports as source documents for inclusion in regulatory filings and support the generation of appropriate responses to questions from regulatory authorities.
- Leads a high-performing team of analytical scientists who are cross-functionally aligned with Pharmaceutical Development Compound Teams, strategies and priorities to ensure individual development candidates are advanced to meet global project requirements and corporate objectives.
- Provides committed and inspiring leadership, stewardship and advocacy, striving for scientific understanding, process knowledge development, continuous improvement, acceleration, risk assessment and mitigation, resource allocation and support, as appropriate.
- Recognizes and resolves broad based complex issues across organizational boundaries.
- In-depth knowledge on how to develop, optimize, validate / qualify, and transfer analytical methods.
- Ph.D. in Analytical Chemistry, Pharmaceutical Chemistry or related scientific discipline. 15 + years experience in the pharmaceutical industry with increasing scientific and leadership responsibilities in analytical development
- Broad knowledge of the pharmaceutical development and commercialization process
- Experience with CMC technical sections of regulatory submissions and addressing regulatory authorities on technical matters
- Excellent communication skills (oral, written, presentation)
- Demonstrated experience managing technical professionals including PhD staff, with a track record of fostering staff development
- Demonstrated situational leadership skills (e.g. teambuilding, facilitation, conflict resolution, persuasion, negotiation)
- Identifies analytical science capabilities and technology tools needed to enable pharmaceutical manufacturing process development and understanding of development candidates and their quality and performance attributes.
- Supports and develops the scientific and technical capabilities of the function and the development of scientific and management staff.
- Leverages scientific and pharmaceutical development knowledge and cross-functional experience to drive collaboration, interpretation of data to inform decision-making and value to BMS.
- Develops, ensures the delivery of high quality-related documentation to meet global regulatory expectations for analytical methods and controls. Delivers analytical source documentation for CMC sections of IND/CTA/NDA filings for Celgene NCEs. Addresses technical inquiries from regulatory agencies to support clinical trial and commercial marketing applications.
- Provides input to the development of project strategies, budgets, timelines, and product development plans. Helps ensure that scientific and business expectations are met.
- Builds and maintains strong working relationships with colleagues in Research and Development, Regulatory CMC, Quality, and Technical Operations as well as alliance partner counterparts, as applicable.
- Participates in due diligence assessments of potential business development interests, with ultimate responsibility for ensuring attention to small molecule analytical considerations.
- Creates an environment that attracts, develops, retains and promotes diverse scientific, technical and management talent
Ideal Candidates Would Also Have:
- Creates an impactful vision for the function and communicates a supporting strategy to align people, resources and management.
- Sets high performance expectations and holds others accountable for the results expected.
- Encourages new ideas, technologies, processes, and approaches.
- Anticipates needs, assesses and manages business risks and organizational dynamics as well as their implications.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to email@example.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.