Associate Director, Oncology Clinical Biomarker Asset Lead – Translational Development

Role Overview

• The Clinical Biomarker Asset Lead role will be responsible for development and execution of translational strategies in solid tumor oncology for assigned programs.
• Act as a lead scientist to implement and deliver on biomarker strategies for clinical programs, develop reports and publications on translational data generated to support asset development and contribute to regulatory submissions.
• Work on cross-functional project teams to drive execution of translational/biomarker plans working with disease and lab scientists, as well as BMS members from clinical, medical, commercial, regulatory, and diagnostics.
• Engage with external academic collaborators/Key Opinion Leaders (KOLs).
• Integrate translational research and clinical development, developing biomarker strategies in alignment with clinical development objectives, leading efforts for data generation and interpretation and for communication to the development teams.
• Responsible for understanding external research environment, partnering with other functions both internally and externally to coordinate the execution of Translational development deliverables.
• Engage functional groups to develop, champion, implement and align biomarker strategies for development projects in support of the overall R&D portfolio goals.
• Effectively engage with teams and matrix leadership to define, revise and progress translational biomarker plans.
• Continually analyze progress, engage in critical thinking, and assert strong problem-solving towards delivering key data and interpretations essential for decision making.
• Deliver high quality biomarker strategies for understanding mechanism of action/resistance, target engagement, pharmacodynamics endpoints and patient selection.
• Ensure the output of the biomarker plans meets established project standards.
• Engage team members to ensure alignment of biomarker strategies with clinical operational plans and with functional area capabilities to execute and deliver on robust translational biomarker data package to support trial and program.
• Build productive relationships with team members that interact with the translational clinical biomarker group.
• Effectively interface with functional areas to ensure strategic alignment and to identify resources needed to deliver on biomarker goals.
• Productively engage with external collaborators and scientific KOLs to support translational goals.
• Communicate key biomarker program information, risks, and milestones, and manage information flow across team members.

Requirements

• Ph.D. in Oncology/immunology or related field with 5-8+ years of industry experience
• 3-5 years in oncology/biomarkers/translational or correlative research
• Previous experience as Biomarker Lead for late-stage clinical trials; Experience in phases II/III required
• Requires comprehensive knowledge of principles, concepts and / or methodologies within drug discovery or clinical development
• Has significant understanding of the role of translational research/medicine and clinical biomarkers in drug development
• Demonstrated knowledge of oncology and/or tumor-immunology disease biology
• Regulatory submissions drug approvals in solid tumor space also highly desirable
• In-depth understanding of solid tumor oncology with knowledge of current and evolving clinical 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 experience with implementing a biomarker strategy
• Clinical 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
• Excellent data analysis and problem-solving skills
• Exceptional verbal and written communication skills with experience in developing written documents such as primary manuscripts/publications/reviews, scientific presentations and regulatory submissions (INDs/NDAs) with ability to synthesize complex scientific concepts into simple communication points
• Proven scientific/project leadership expertise and experience working in global teams and managing people/projects

Benefits

• 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 US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays. Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.