- In-depth understanding of cancer biology/hematology, knowledge of clinical landscape, evolving therapeutic landscape and competitive scenarios
- Strong scientific background with understanding of clinical, translational, and mechanistic data with proven track record of publications
- Understanding of early or late-stage drug and translational development process; including clinical trial experience in industry or academia
- Protocol authoring and review of regulatory documents.
- Working knowledge of technological platforms covering biomarker measures including but not limited to genomics, gene expression, immune profiling, and flow cytometry.
- Proven ability to work with global disease teams to develop drug development strategies
- Exceptional verbal and written communication skills with experience in developing written documents such as primary manuscripts/publications/reviews, disease strategies, scientific presentations and regulatory submissions (INDs/NDAs)
- Proven scientific/project leadership expertise (working in teams, managing people/projects)
- Excellent communication skills with ability to synthesize complex scientific concepts into simple communication points
- Excellent data analysis and problem solving skills
- Agile to adapt to a fast paced work environment and changing priorities
- Leads the development of asset specific translational goals and objectives for the Hematology Translational Medicine group
- Represents Translational Medicine (TM) on cross-functional Strategy and Global Project Teams
- Oversees biomarker plan development and execution in clinical trials and supports clinical trial operations in regard to biomarker sampling
- Supports regulatory submissions, regulatory interactions, writes translational sections for regulatory responses and answers to regulatory queries for the TM group
- Participate/present data at scientific advisory boards to support drug programs/projects
- Communicates regularly and prepares and makes presentations within the department and externally as required
- Participates in translational research with the hematology laboratory and disease teams
- Responsible for selection and delivery of Clinical PD or Biomarker assays including assessing the need and applicability for companion/complementary diagnostics for asset programs
- May participate in BD and established teams to evaluate the potential in-licensing opportunities that will advance our Drug Discovery and Development pipeline
- May perform advisory and mentoring role for junior scientists
- Assists in developing and maintaining group budget and workforce plan
- Bachelor's Degree
- 10+ years of academic and / or industry experience
- Master's Degree
- 8+ years of academic and / or industry experience
- Ph.D. or equivalent advanced degree in the Life Sciences
- 6+ years of academic and / or industry experience
- 2+ years of leadership experience
- PhD in Hematology/Oncology or related field with min 6-8 years in industry and academic setting
- Track record in drug discovery/development in large or small biotech/pharmaceutical companies, leading translational/biomarker studies or innovative efforts to deploy technologies and assays for enhanced translational capabilities or similar skill sets in academia
- Experience with translational/biomarker strategies for early or late stage clinical trials or investigator sponsored trials in academia
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Senior Principal Scientist - Summit, NJ, United States - Bristol-Myers Squibb Company
Description
Working with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible. 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. Read more: Translational Medicine is part of the Global Research and Early Development organization in BMS and leads mid to late stage clinical, pharmacological, and translational research and development activities for the BMS hematology pipeline and supports late-stage portfolio for translational development and life cycle management. Translational Medicine Hematology at BMS has a long-standing history of scientific rigor as evidenced by our peer-reviewed publications, delivery of drug approvals including Revlimid, Pomalyst, Idhifa, Inrebic, Reblozyl, Vidaza and Onureg, strong academic collaborations and talent development. Our areas of focus include but are not limited to Multiple Myeloma, Acute Myeloid Leukemia/MDS, Lymphoma and Erythroid disorders. This group integrates scientific learnings from the lab and clinic as well as business insights of multiple functions and leads the development of translational strategies at the franchise level. The Senior Principal Scientist role will be responsible for development and execution of drug and myeloma asset centric translational strategies in hematology for assigned programs. Key responsibilities of this role are to act as a lead asset scientist to deliver and implement biomarker strategies for clinical programs and influence programs regarding clinical implementation of novel assays, identification of high-risk sub populations, patient selection and combination strategies for our pipeline as well as regulatory support including pre-clinical and translational sections of NDA submissions. This individual will work on cross-functional project teams to drive execution of translational/biomarker plans working with laboratory and disease scientists and BMS members from clinical, commercial, regulatory and diagnostics as well as engage external academic collaborators/Key opinion leaders (KOLs). This position can be located in Summit, NJ or San Francisco, CA. Professional Skills:
With a single vision as inspiring as "Transforming patients' lives through science ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to Visit to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
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