Director, Global Clinical Physician - Early Clinical Development Oncology

Bristol Myers Squibb•Madison, CA

2d•Onsite

About The Position

Serves as a primary source of medical accountability and oversight for multiple clinical trials. Manages Phase I/II studies, with demonstrated decision making capabilities. Provides medical and scientific expertise to cross-functional BMS colleagues. Maintains matrix management responsibilities across internal and external networks.

Requirements

Advanced degree(s) in relevant field: MD, MD/PhD (or x-US equivalent) and clinical expertise in a therapeutic area (e.g., attending level or international equivalent).
5+ years of relevant experience in discovery, translational and/or clinical research in academic or industry setting including education where applicable.
Ability to communicate and present information clearly in scientific and clinical settings.
Expertise in the scientific method to test hypotheses, including statistical design, analysis, and interpretation.
Knowledge of drug development process.
Knowledge of the components needed to execute an effective clinical plan and protocols.
Strong leadership skills with proven ability to lead and work effectively in a team environment.

Nice To Haves

Subspecialty fellowship training in applicable therapeutic area preferred.

Responsibilities

Serves as an independent Medical Monitor for clinical trials from Phase 1 through Proof-of-Concept.
Articulates clinical development strategy.
Analyzes, interprets, and acts on clinical trial data to support development.
Serves as principal functional author for Regulatory submission, study reports, and publications.
Provides oversight and medical accountability for multiple trials across early development clinical lifecycle.
Manages site interactions in partnership with the Clinical Scientist for medical questions and education (including safety management guidelines).
Assesses key safety-related serious adverse events in partnership with Worldwide Patient Safety and oversees contributions to safety narratives.
Contributes to and is a key member of a high performing Study Delivery Team (SDT) and may be a member of the Development Team.
Collaborates with Clinical Scientists and provides input into protocols, contributing medical strategic oversight in protocol development (input on inclusion/exclusion and other safety-related clinical considerations).
Fulfills GCP and compliance obligations for clinical conduct and maintains all required training.
Acts as a focal point for defining and establishing relationships with key global Phase I Centers.
Works on multiple trials across early development clinical lifecycle.
Designs and develops clinical studies and research plans in support of asset strategy with the Early Clinical Development Leadership team; clinical studies include first-in-human Phase I, proof of concept Phase I/II, entry registrational studies, biomarker qualification studies, and/or clinical pharmacology studies.
Liaises with Clinical Scientists, Translational & Discovery Scientists and Development Teams to define dose and schedule, indications, and patient selection (e.g., biomarker qualification and implementation).
Leads the analysis of benefit/risk for clinical development protocols in a matrix team environment working with Clinical Scientists.
Partners with Clinical Scientists to support executional delivery of studies (e.g., site activation, enrollment status, as well as adjudication for protocol violations, significant, non-significant deviations etc.).
Maintains a strong medical/scientific reputation within the disease area; has in-depth knowledge of etiology, natural history, diagnosis, and treatment of the disorder.
Keeps up to date in the disease area by attending scientific conferences and ongoing review of the literature.
Contributes to key Health Authority interactions and advisory board meetings as Early Clinical Development Physician.
Serves as Primary Clinical Representative in Regulatory interactions for early development projects.
Authors/drafts clinical content for CSRs, regulatory reports, briefing books and submission documents to support closure, clinical narratives, reporting and filling of the study in partnership with Clinical Scientists.
Sits in team responsible for establishing key alliances with academic centers, co-operative groups, vendors and government agencies.
Represents department in business development due diligence and partner alliance management with oversight.

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.
Annual Global Shutdown between Christmas and New Years Day.