Bristol-Myers Squibb Company

Development Lead, Innovative Medicine Development, Eliquis Pediatric and Factor XI

Location
Princeton, NJ
Posted
Nov 27, 2018
Ref
R1511755
Required Education
Doctorate/PHD/MD
Position Type
Full time
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

Role Summary:
The Full Development Lead is accountable for the vision and growth of Eliquis, with a focus on the successful completion of the pediatric development program, as well as the Factor XI program by driving the asset development strategy, including scientific, regulatory, clinical, and post-marketing data generation (e.g., HEOR/Real-world data). This position is vital to BMS business strategy and overall financial success of the company.

The Full Development Lead reports to the Head of Cardiovascular Development.

Key Role Accountabilities:

Strategy & Execution
  • Creates and delivers asset/brand vision and strategy through all lifecycle development activities, including registrational studies for first as well as additional indications (FXI), as well as post-marketing studies including both clinical (focus on pediatric drug development) and HEOR studies (Eliquis).
  • Shapes products for competitive profile that achieves pricing, reimbursement, access and penetration for favorable shareholder return by developing target product profile, developing initial label in-line with target profile, and creating economic value dossier
  • Partners effectively with the Medical and Commercial organizations to drive asset strategy
  • Oversees and adheres to the Product Development and Commercialization (PD&C) processes for the selected asset and the achievement of key milestones
  • Drives strategy for scientific, regulatory, clinical and HEOR/Real-world data needs and identifies potential risk mitigation strategies by driving execution of development plans (including clinical, LCM clinical strategy and dosing strategy, updating core data sheet with new data, and creating and updating global regulatory submission plans)
  • Improves customer insights with meaningful scientific exchange with thought leaders
  • Drives the successful completion of the Eliquis pediatric development program including site interaction, matrix team leadership across the alliance, scientific leadership and regulatory interaction


Drug Development Experience
  • Demonstrates a working knowledge of the drug development process, along with experience in one or more of the relevant areas (e.g. clinical, regulatory, program management, project planning and management, clinical pharmacology, statistics) preferably with experience in pediatric development.
  • Specific knowledge and experience in the pediatric development of CV drugs including relevant regulatory interactions, matrix team leadership, scientific/clinical leadership is strongly desired.


Leadership & Matrix Management

  • Sets a vision for the (Full) Development Team, and engages the matrix team on that vision.
  • Strong matrix leadership capability across two alliances
  • Manages performance across the matrix team, in collaboration with the functional leaders.
  • Secures required headcount and budget to achieve global PD&C plan and drives allocation and prioritization of activities across Research and Development, including Regulatory, Worldwide Medical, etc.
  • Oversees relevant sub-teams and ensures clear goals and performance standards are in place, provides feedback and coaching, and holds sub-team leaders accountable for key deliverables
  • Creates development strategies that meet Access requirements and support value story by data generation and interpretation and WWHEOR studies in place to support value story
  • Demonstrates peer-to-peer influence across R&D functional leadership

Stakeholder Engagement & Communication
  • Manages integration points and outbound/inbound communications with key stakeholders across all BMS functional and market areas to ensure alignment and minimize risk
  • Ensures appropriate decisions are made in a timely manner and agreed with the appropriate levels to drive PD&C milestones
  • Builds and manages relationships with external stakeholders (Opinion Leaders, Strategic alliance partners, Patient advocacy leaders, health authorities)
  • Develops an overall communication strategy as well as the publications strategy and plan, PR plan and Broad internal communications
  • Interprets of key clinical trial results
  • Interprets key regulatory milestones, communications, and engagements
  • Communicates key clinical trial results and regulatory milestones to appropriate governance boards

    Role Qualifications:
  • MD / PhD / PharmD / secondary scientific degree preferred
  • A minimum of 10 years of experience in the pharmaceutical industry, with proven progression in relevant R&D roles and significant experience in related therapeutic area as well as pediatric drug development.
  • Extensive working knowledge in the drug development process, along with experience in one or more of the relevant areas (e.g. clinical, regulatory, program management, project planning and management, medical)
  • Experience in managing/leading high performance, cross-functional teams (Matrix) or complex organizations successfully
  • Experience in setting development plans (internal/external new product development), commercialization (marketing, sales and market research) and life cycle management processes
  • Understanding of regulatory policies and impact of public relations (US and Global preferred)
  • Demonstrated ability to successfully and effectively collaborate, cooperate and work across boundaries (e.g. R&D, disease mgt., marketing, external development) and building strong external relationships
  • Abreast of scientific issues as they impact business development and strategic planning
  • Success in situations requiring rigorous, analytical problem solving and the ability to determine scientific opportunity and commercial targets
  • Broad and in-depth understanding of domestic and international issues relative to the pharmaceutical industry
  • Understanding of regulatory policies and impact of public relations
  • Demonstrated use of communication and change management strategies/tactics to influence new ways of thinking and working
  • Success in effectively communicating and influencing decisions with senior management
  • Ability to navigate through ambiguous and changing healthcare landscape