Senior Director, Global Clinical Development (GI Oncology)

Bristol Myers Squibb•Princeton, NJ

18h•Onsite

About The Position

The Senior Director, Global Clinical Development serves as the Clinical Indication Lead for one or more indications of a given asset. This role is accountable for clinical strategy and execution in the given indication(s). This role leads a team of physicians and scientists in the design, execution, analysis, and interpretation of all clinical studies for respective indications of a given asset.

Requirements

Advanced degree in Life Sciences required (PhD, PharmD, MS, RN, MD or related field, MD)
Deep clinical and therapeutic area expertise with advanced knowledge of drug development, competitive landscape, and health authority expectations.
8+ years of relevant experience, including leadership in the design and execution of multiple clinical trials.
Demonstrated success in people leadership and/or matrix leadership roles.

Responsibilities

Owns and drives clinical development strategy across given asset indications, aligned to overall asset strategy, Target Product Profile (TPP), and relevant disease area strategy.
May lead the Clinical Development Team(s) for given indication(s) depending on program structure.
Provides clinical and disease area expertise to integrated disease area and portfolio and therapeutic level strategies.
Represents Clinical as the internal and external authority for the indication/disease area, including regulatory interactions and Business Development support.
Engages cross-functionally with internal leaders and partners with external investigators, key opinion leaders, and patient advocacy groups.
Presents clinical strategy, data, and risk assessments to governance bodies, health authorities, and senior leadership.
Leads a team of physicians and scientists in the design, execution, analysis, and interpretation of all clinical studies for given asset indication(s).
Ensures studies meet regulatory, quality, medical, and access objectives and are aligned with target label indications.
Ensures high quality, timely delivery of innovative protocols and data packages for CSRs and Regulatory Filings; implements quality assurance plans.
Accountable for clinical content and data quality for CSRs, trial documents, regulatory submissions, briefing books, and publications.
Oversees trial progress, proactively identifies and mitigates risk, and provides regular status and risk updates to senior management.
Champions quality, compliance, and GCP adherence across all clinical activities, partnering with Development Operations and Compliance as needed.
Sets priorities aligned to program objectives and works with Clinical Asset leadership to ensure appropriate budget/resourcing.
Attracts, develops, and retains top clinical talent through effective leadership, mentoring, and training.
Fosters a culture of scientific excellence, collaboration, innovation, and accountability.

Benefits

Medical, pharmacy, dental, and vision care.
BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
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.
flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)) for US Exempt Employees.
160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays for Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees.
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
an annual Global Shutdown between Christmas and New Years Day.