Associate Director/Director, Global Clinical Research, Virology & Genetically Defined Disease

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.

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. And 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.

· Clinical development studies and/or programs. · Leads/co-leads high performing global protocol team(s) across functions and geographies in a matrix team environment. · Develops protocol team objectives and priorities to manage workload in a cross functional matrix protocol team. · Works with Clinical Lead, team members, stakeholders and governance bodies to translate protocol strategy into objectives and action plans. · Influences the allocation of resources to be consistent with priorities, and aligns own activities to adjust to project priorities. · Designs and develops clinical plans and protocols based on knowledge of the asset/drug, disease area and relevant science in order to meet regulatory and disease strategy targets. · Leads the analysis of benefit/risk for clinical development protocols in a matrix team environment. In collaboration with regulatory (GRS) and pharmacovigilance (GPV&E), designs and implements safety monitoring plans. · Interprets clinical data and makes appropriate decisions and recommendations to the Clinical Development Team. Clinical development expertise & strategy: · Identifies and builds relationships with principal investigators. · Identifies and cultivates thought leaders (TLs) in order to gain their inputs on emerging science in drug and biomarker research, disease knowledge and design of clinical development studies and programs. · Builds productive relationships, networks and alliances with internal and external partners such as CROs, alliance partners, regulatory authorities, universities and scientific associations. · Clearly outlines expectations for internal and external partners. · Challenges and shapes the decisions of others while preserving relationships. · Maintains a strong medical/scientific reputation within the disease area. · Has in depth knowledge of etiology, natural history, diagnosis, and treatment of the disorder. · Keeps up-to-date in the disease area via attendance at scientific conferences and ongoing review of the literature. · Understands the benefit/risk of key competitor drugs and how our portfolio fits into the competitive landscape. Health authority interactions & publications: · Contributes to Health Authority interactions as Medical Monitor on assigned clinical development study. · Appropriately partners with regulatory (GRS) and pharmacovigilance (GPV&E) departments to manage issues of ethics, safety and regulatory obligation. · Responsible for contributions to development of safety update reports (DSURs) and to the establishment of key regulatory documents including product labels.

**Reporting and developmental value:** · Reports to Clinical Lead or Group Director in Global Clinical Research. · Broad experience in management of and participation in functional and cross functional based matrix teams. · Gain a broad perspective of the pharmaceutical development process and the company's development strategy. Experience desired: · More than three years within the industry or in a similar position. · MD (functional assignment as Medical Monitor); specialty training in Internal Medicine, Pediatrics, or Neurology desirable. · Writing of clinical study protocols, monitoring of clinical trials. · Working effectively in a matrix organization.