Senior Director, Global Clinical Development – Neuroscience
United States
Full Time
3 hours ago
$244,560 - $331,907 USD
Visa Sponsor
Key skills
Google Cloud PlatformPhoenixGCPGoogle CloudLeadershipRisk ManagementMentoring
About this role
Role Overview
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)
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)
Tech Stack
Google Cloud Platform
Benefits
Health Coverage: Medical, pharmacy, dental, and vision care.
Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
Financial Well-being and Protection: 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.
Work-life benefits include: Paid Time Off
US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
Based on eligibility*, additional time off for employees may include 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 and an annual Global Shutdown between Christmas and New Years Day.
Senior Director, Global Clinical Development – Neuroscience at Bristol Myers Squibb | JobVerse