Facebook pixel

Clinical Development Lead
Cardiovascular
Posted on 7/6/2022
INACTIVE
Locations
San Bruno, CA, USA • Princeton, NJ, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Development Operations (DevOps)
Google Cloud Platform
HTML/CSS
Leadership
Management
Marketing
R
Research
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 11years of relevant experience
  • Able to synthesize internal and external data to produce a clinical strategy
  • Demonstrated success in formulating clinical development strategy across increasingly complex clinical programs with large impact on the business
  • Able to ensure that the clinical program will result in a viable registrational strategy
  • Demonstrated success in designing and executing multiple clinical trials, with significant experience as a clinical leader
  • Has achieved the knowledge base to serve as a a trusted internal expert in the therapeutic area, asset, indication, and clinical development, and is viewed as a peer by external academic collaborators and other KOLs
  • Able to assess personnel needs, translate into a hiring strategy, and lead the hiring efforts
  • 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
  • Verifiable track record of successful people management and development or leadership in a matrix team (e.g. mentoring junior colleagues)
  • Interface across multiple functions to mediate conflict resolution, and champion an organizational culture to promote behaviors that lead to meaningful synergies and superior performance
  • Expertise in implementing scientific methods to test hypotheses, design, analyze, interpret and report results
  • Ability to recognize, articulate, and accept calculated risks to make informed decisions
  • Deep understanding of the fundamentals of protocol development and follow up, including but not limited to study monitoring, data collection and analysis, database cleaning and database lock
  • Understanding of pharmacokinetics, biomarkers, statistical principles, and regulatory requirements
  • Comfortable working in a fast-paced environment; ability to support multiple, complex, studies in parallel
  • Willing to work outside of a traditional functional environment, in a team unified around serving the assets
  • Willingness and ability to form strong, productive partnerships with external providers/thought leaders
  • Possess excellent communication skills and experience delivering effective presentations on both technical and non-technical subjects
  • 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)
  • Ability to lead and develop a group of CTPs to ensure scientific and technical excellence of clinical development programs and deliverables
  • Minimum 3 years experience as a medical monitor with proven track record designing and overseeing clinical trials, ideally both early and late stage
  • Experience supervising CRO-driven studies
  • Experience with health authorities and regulatory submissions
  • Understanding of the clinical development process, and the role of non-R&D functions: commercial, health outcomes, access, medical
  • Proven ability to partner effectively with key internal and external stakeholders
Responsibilities
  • CDLs are matrix leaders and managers who lead, develop, motivate and achieve results through teams; demonstrate a commitment to the development of a resilient attitude, embrace change and have an unwavering commitment to our People Strategy
  • Serves as the clinical point of accountability for the Development Team and is responsible for navigating the overall clinical development plan for complex programs that have a large impact on the business Ensures clinical studies are aligned with target label indications and are designed to meet regulatory, quality, medical, and access goals
  • Serves as a matrix leader to lead, develop, motivate and achieve results through teams, and is the direct manager to Clinical Trial Physicians (CTPs)
  • 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
  • Responsible for managing clinical trial physician(s); attracting, developing and retaining top talent; ensuring appropriate training and mentoring of clinical trial physicians
  • 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, to seek input into the design, execution, analysis and reporting of studies
  • 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.