Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
Vice President, Head of US Medical Affairs, Hematology & Oncology is responsible for managing all US Hematology & Oncology Medical Affairs Hematology & Oncology functions to ensure a productive and appropriate medical partnership with the US business and key stakeholders, and that all activities are conducted in compliance with company expectations. This role is
responsible for direct leadership and management of US region with broad responsibilities and impact to US business and overall Global Medical Affairs organization including the US IIT programs.
• Responsible for directing and managing the US Medical Affairs team in hematology & oncology, including MSLs and US Disease Teams with ownership and accountability to drive US Medical Affairs programs and related processes.
• Provide inspirational leadership and focus to US Medical Affairs team and ensure delivery of US Medical Affairs goals and objectives as related to Global Medical Affairs and corporate objectives in a highly dynamic environment. Develop and own career ladders for the various functions within US Medical Affairs.
• Responsible for management of US MSL field force, including training department; setting goals and objectives for field force; developing and improving performance metrics and measures of customer satisfaction; sizing of field force appropriate for new drug launches and/or indications. Prioritize MSL activities across diseases and indications. Develop MSLs for payer presentations and to support translational efforts of CRD trials.
• Oversee the US IIT process, from receipt of proposals through approval, including IRC approval process, budget negotiation, contracts, and study execution. Manage operations team to handle all aspects of US IIT program. Develop US open data questions in close collaboration with global disease teams, market access, and marketing. Work closely with corporate Medical Affairs and IT to implement databases and processes to manage US IIT program.
• Responsible for the management of the departmental budget and workforce plan under SVP oversight.
• Oversee the conduct of US Medical Affairs Sponsored Trials (MAST):
o Obtain G3M Steering committee and HODC approvals for the study designs and budgets
o Develop synopses, assure SRC approval of the synopses
o Develop protocols
o In close collaboration with Clinical Operations and local Medical Affairs teams, select centers
o Develop Case Report Forms
o Assure enrollment time-lines are met
o Establish monitoring guidelines for field monitors and Clinical Research Scientist, and oversee data cleaning
o Prepare SAP in collaboration with statistics and oversee data analyses
o Oversee publication and presentation of the results at medical meetings
o Oversee the drafting of the Clinical Study Report in collaboration with Medical Writing
• Work closely with Clinical Research and Development, and Scientific Communications on setting and meeting goals for US publications.
• Work with Disease Strategy Teams to ensure effective development of disease plans and brand plans, containing appropriate input from Medical Affairs. Develop US tactics in alignment with US and global strategic imperatives and with the US business.
• Develop US advisory board plan for the entire portfolio.
• Work with Corporate Affairs Group to foster patient advocacy group relationships.
• Interact with national accounts to assure medical support for insurers and benefits managers.
• Develop and maintain key opinion leader relationships in the US. Implement measurable policies regarding customer and product medical education within the team to assure a high level of customer satisfaction and compliance.
• Collaborate with other divisions/therapeutic areas to leverage US Medical Affairs expertise and programs.
• In collaboration with CRD leadership and Clinical Operations, assist CRD in site selection, site opening, and study enrollment
• Ensure and lead close collaboration between US Medical Affairs teams and the Global Medical Affairs and Corporate
Medical Affairs teams.
• Responsible for all metrics pertaining to US IIT program and US MSL program.
• Lead and conduct the performance management and merit process throughout the year for the US Medical Affairs team;
responsible for assuring US Medical Affairs employees are properly managed, qualified and trained to perform their jobs
• Coach, manage and mentor direct reports while providing job enrichment and developmental opportunities. Assure timely goal and individual development plan setting
• Conduct field visits as appropriate.
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have
authorization to work for Celgene in the U.S.