Senior Director managing execution of clinical trial programs to advance gene therapy. Leading clinical operations, ensuring strategic execution, and mentoring clinical teams across multiple clinical programs.
About the role
- Clinical Development Lead responsible for oncology drug development strategy and execution. Leading clinical trials and managing cross-functional teams for successful outcomes.
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
- 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 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
Requirements
- MD required with a deep understanding of the clinical principles of the area of interest or equivalent therapy area knowledge
- At least 10 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 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)
Benefits
- Medical, pharmacy, dental and vision care.
- Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP).
- Financial well-being resources and a 401(K).
- Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support.
- Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility.
- Parental, caregiver, bereavement, and military leave.
- Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources.
- Other perks like tuition reimbursement and a recognition program.
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