Therapeutic Area Lead, Genetically Defined Diseases

Bristol-Myers Squibb

(Princeton, New Jersey)
Full Time
Job Posting Details
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global BioPharma company firmly focused on its mission to discover, develop and deliver innovative medicines to patients with serious diseases.
Summary
The Therapeutic Area Lead is a senior leader in the Global Biometric Sciences (GBS) organization and serves as a member of the Specialty GBS Leadership Team. As such, this role has accountabilities to the sustained health, growth and continuous improvement of the GBS organization, inclusive of developing effective partnerships with critical stakeholders across R&D, particularly with the Early Clinical and Translational Development and the Global Clinical Research organization. Along with leaders from other stakeholder groups, this position provides scientific oversight and leadership that ensures early development teams design programs that enable regulatory approvals and successful market access. The Therapeutic Area Lead serves as an escalation point when Early Development Teams are not able to resolve conflicts. This position contributes to setting the strategic directions of Specialty GBS and focuses on building the organization through leading the acquisition, development and retention of talent. The Therapeutic Area Lead manages Statistical Leads and other biostatisticians and has responsibility to provide leadership and mentorship to GBS staff, even if outside of their direct reports or group. This position reports to the GBS Head for Specialty Development.
Responsibilities
* Provides statistical and clinical trial expertise, and disease area and regulatory experience to the R&D organization. * Influences therapeutic area planning and decision-making strategy over a portfolio of development compounds, through effective partnership with the GBS Planning and Business Operations group (PBO), senior leaders in across the organization. * Serves as a senior reviewer for project related documents and represent at Protocol Review Committee. * Represent GBS at End-of-Phase I and IIa meetings with the FDA and in interactions with other global regulatory agencies as needed. * Provides input and direction to Statistical Leads on critical development issues, including data interpretation and preparing messages for senior management and on emerging scientific issues. * Serves as a member of the Specialty GBS Leadership Team. Drives the development and execution of GBS Strategic Plan as it relates to Specialty Development goals and is accountable for its implementation. * Contributes to the development of innovative processes and adoption of technologies that ensure the delivery of high quality and timely statistical analyses and data reporting. * Effectively communicates the GBS Mission and Vision in a fashion that generates pride, excitement and commitment within GBS. * Serves as a departmental representative on committees/initiatives within R&D with particular attention to GBS initiatives, as needed. * Translates strategies into operational goals and objectives. Identifies necessary resources to accomplish goals and, in collaboration with the Planning and Business Operations group, develops effective and strategic staffing solutions to manage resources, in accordance with R&D priorities/timelines/strategies, across multiple drug development programs. * Models scientific and functional leadership as well as core behaviors to GBS staff and other key stakeholders. * Recruits and retains high quality staff to ensure a strong pipeline of talent. Reinforces the BMS commitment to leadership and scientific/strategic development by providing training and experiential opportunities, and continuous coaching and feedback.
Ideal Candidate
* Ph.D. or equivalent in Biostatistics or related field with > 10 years of experience in clinical research, preferably in the pharmaceutical industry. * Demonstrated performance in scientific and strategic support of the drug development process leading to successful regulatory filings. Experience in rare disease or genetically defined diseases is preferable. * Experience in managing biostatistics teams and developing biostatisticians * Knowledgeable about strategic directions for the GBS organization across the pharmaceutical industry. * Experience interacting with senior level business partners and interacting with BMS governance bodies and external providers. * Strong communication/presentation skills with ability to tailor the message to key stakeholders for effective impact and influence. * Ability to be flexible and adapt quickly to the changing needs of the organization. * Ability to organize multiple work assignments and establish priorities. * Demonstrated ability to operate and lead in a matrix organization, building successful working relationships and effective stakeholder management in an environment with multiple lines of authority and competing needs. * Demonstrated experience in planning and executing research activities in close collaboration with medical, clinical, regulatory and commercial partners.

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