Role Summary
Head of the Global Development Operations function, accountable to lead an integrated, end to end global clinical operations function accountable for acceleration and delivery of clinical trials across the full company product portfolio (Phase I - IV).
Responsibilities
- Member of the Drug Development Leadership Team, reporting to the Chief Medical Officer
- Anticipates & drives strategic evolution of GDO function and provides strong leadership and vision for the function and in the execution of clinical trials
- Manages, builds and leads global development operations function to execute and achieve functional responsibilities and program goals in compliance with GCP, ICH and other global regulatory requirements
- Provides comprehensive strategic leadership for 2,100+ multi-site organization across 40+ countries; including Regional Clinical Operations, Global Trial Management, Global Data Management and Trial Delivery Support.
- Optimizes clinical trial costs, CRO contracts as part of continued strategic value capture
- Accountable to deliver innovative digital solutions to optimize and accelerate the clinical trial process
- Collaborates with development heads to establish clear strategy & objectives for clinical trials and programs including estimation and articulation of risks/benefits
- Delivers on BMS Diversity Commitments by increasing patient voice and diversity in BMS-conducted clinical trials
- Maintains full GCP compliance and ensures the highest ethical standards of clinical trial and business conduct
- Ensures that all operations comply with local HR, health, safety, environmental/risk management legislation and GCP as well as with corporate compliance policies
- Identifies and grows the next generation of GDO and DD leaders in partnership with the rest of the DD Leadership Team
- Influences beyond area of responsibilities to drive innovation agenda by partnering with all relevant stakeholder groups incl. Research, GPS, Commercialization and supporting functions.
- Maintains global leadership and external reputation that attracts outstanding staff and commands respect of investigators to provide competitive superiority for BMS
Qualifications
- Bachelor's degree in Science or Business, Advanced degree strongly preferred.
- Significant experience (20+years) of drug development or related experience managing clinical and CMC development under a variety of contexts; multiple clinical trials and operations required (ideally with pharma co and /or CRO)
- A demonstrated track record of success leading, engaging, managing, and developing a large global multi-site, multi-cultural organization
- Leadership experience of a large-scale enterprise transformation at global level, with a significant R&D component as a key driver (renewal of portfolio, development cycle. M&A activity)
- Ability to develop strong working relationships with key internal stakeholders and outside of BMS (functional and project leaders, peers and employees at all levels, vendors, Pharma industry community)
- Demonstrated ability to develop strategic direction for GDO in support of R&D strategy
- Strong scientific competency and credibility
- Excellent leadership capabilities able to engage and inspire a fast-moving organization.
- Managing cross-geographic and complex organizations, processes, technology and talent
- Experience driving transformation across organizational changes, digital uplift and accelerating ways of working
- Experience having developed next generation leaders in previous assignments