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Clinical Development Lead
Posted on 7/14/2022
INACTIVE
Locations
Princeton, NJ, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Development Operations (DevOps)
Google Cloud Platform
HTML/CSS
Leadership
Management
Marketing
Requirements
  • MD preferably with appropriate sub-specialty training as appropriate
  • PhD, Pharm D or other health related scientific field with a deep understanding of the clinical principles of the area of interest or equivalent therapy area knowledge
  • At least 9 years of relevant experience
  • CDL has demonstrated leadership in the design and execution of multiple clinical trials (e.g. significant experience as a senior clinical leader), and exhibits all of the following attributes:
  • Able to synthesize internal and external data to produce a clinical strategy
  • Able to ensure that the clinical program will result in a viable registrational strategy
  • Able to work with other stakeholders to ensure a robust enterprise level strategy for asset(s) and indication(s) including early, late and post-marketing development, as well as awareness of the enterprise disease area portfolio
  • CDL has demonstrated, sustained excellent performance as Clinical Trial Physician, Clinical Scientist, or equivalent
  • CDL has demonstrated excellent skills in clinical development strategy including the clinical components of regulatory submission(s)
  • External focus to understand the trends in the disease area treatment paradigms and ability to build relationships with external partners, thought leaders and collaborators outside of BMS
  • Partner and interact with colleagues from Early Development who design and implement first in human through proof of concept trials and will to assure a seamless transition into late stage development (Phase II-III trials)
Responsibilities
  • Accountable for the clinical contribution to the development of each indication strategy, including registrational and non-registrational studies, with the support of the CTPs and Clinical Scientists (CS) within the asset and/or indication
  • May serve as CTP as necessary
  • Accountable in partnership with the Clinical Scientist for the design, execution, and analyses of each study led by the CTPs and CSs. Should work to proactively partner with these roles
  • Accountable for clinical content for CSRs, regulatory reports, briefing books and submission documents
  • Champions a quality-focused mindset and ensures adherence to GCP and compliance obligations for clinical conduct
  • Represents Clinical Development in both internal and external forums as the consulted authority for the disease area, including within Business Development function
  • Partners with Worldwide Patient Safety physicians in the ongoing review of safety data
  • Serves as the (co-)leader of the cross-functional Clinical Development Team
  • Provides clinical leadership and disease area expertise into integrated disease area strategies
  • Partners closely with KOLs in specific indications
  • Serves as Primary Clinical Representative in Regulatory interactions
  • Evaluates strategic options against a given Target Product Profile (TPP)
  • Collaborates with Global Development Operations/Global Compliance Group to develop asset level risk management plan, resolves issues with Quality/CS, and raises to DT as needed
  • Sets executional priorities and partners with CTP and CS to support executional delivery of studies
  • Accountable for top line data with support of CTP, CS, and Statisticians
Bristol-Myers Squibb

10,001+ employees

Biopharmaceutical development company
Company Overview
Bristol-Myers Squibb engages in the discovery, development, licensing, manufacturing, marketing, distribution and sale of pharmaceuticals.