This position will have primary responsibility for oversight for establishing effective operations of the Medical Affairs function for North America.
Provide supervisory, strategic, operational and medical leadership for Medical Affairs function in North America as well as providing scientific support for the global mission. Participate as a member of Senior Leadership, to represent Medical Affairs and contribute to the vision and mission as determined in senior leadership. Communicate effectively with other departments to align goals to achieve Leadiant Biosciences, Inc. (LBI) patient focused mission throughout North America (specifically for USA and Canada).
Overview Of Responsibilities: (Sr. Director will supervise and align goals of Medical Affairs with Senior Manager/Director, and personnel of MA)
- Work closely with VP of Pharmaceutical Products in the development of big-picture product brand strategies meeting at least twice yearly to formalize strategic goal setting between the two departments.
- Develop a Medical Affairs specific yearly strategic plan incorporating and inclusive of input from members of the Department. Present plan yearly with updates as appropriate to CEO.
- Independently develop and implement the tactical plan that supports brand strategies including guiding the positioning of disease state and available treatments, publication planning, advisory boards, symposia, investigator initiated trials, training programs, and other specific projects involving key opinion leaders.
- Lead or designate a lead for twice-yearly life cycle management retreat, held at Gaithersburg, of approved products. Inform other departments in advance to encourage collaborative development of strategic plans.
- Work with the VP’s of Clinical Development, Scientific Affairs, Pharmaceutical Products, Finance and Supply Chain to provide scientific input for Leadiant Biosciences projects.
- Prepare and deliver updates as requested on all Med Affairs projects, especially IIT’s to senior staff and the Leadiant Board.
- Maintain a leading-edge knowledge base of LBI products, the evolving disease states, emerging treatment paradigms in the Rare Disease space, and other therapeutic areas relevant to the products approved and in the pipeline.
- Supervise the members of Med Affairs to ensure regular delivery of recent and scientifically accurate medical on LBI products, alternative therapies, and disease states:
- Internally to all relevant LBI departments, including but not limited to leading the Knowledge Management program, and regular scientific training to Scientific Affairs, Sales, and other Commercial employees.
- To external audiences through MSLs, Medical Information Services, and Educational Grant programs, assuring scientific integrity and clinical relevance.
- Analyze and assimilate product usage, disease state, therapeutic area, and scientific information to provide accurate information on product differentiation (all products) and understand the differences in regulatory environments (US, Canada, EU).
- Train in the Accountability with Care (AwC) program and implement the program with all direct reports as per the AwC program requirements.
- Perform ongoing performance assessments and yearly performance evaluations of all direct reports including the Senior Coordinator, the Director/Manager in Med Affairs and delegate these evaluations with oversight of the field MSL’s to the Director/Manager.
- Communicate regularly with other LBI departments to maintain daily effective and compliant operations especially around brand strategy and life cycle management.
- Oversee annual budget preparation and LBE1/LBE2 budget revisions with Med Affairs Director/Manager and Med Affairs Senior Coordinator.
- Provide a representative of Medical Affairs to participate in discussion(s) with Scientific Affairs and Product Development of all pipeline projects including pre-clinical and clinical.
MSLS & Field Activities
- Oversee, train or delegate and approve training plan, and manage a team of qualified Medical Science Liaisons and support staff. Ensure the core job functions of the MSL group are executed as well as assess and meet developmental and professional needs of each.
- Attend medical meetings/conferences and advisory board meetings:
- Oversee Medical Affairs booth content and delegate staffing appropriately for proper communication of medical information.
- Supervise the Senior Coordinator to update all teams, including Commercial and Medical Affairs colleagues, of planned attendance/activities.
- Supervise and/or delegate the sharing of information obtained from medical conferences/symposia to all relevant Leadiant members.
- Determine areas where outside scientific input is needed and hold Advisory Boards as appropriate.
- Oversee development of scientific partnerships and relationships with key opinion leaders, medical groups and patient groups.
- Oversee or delegate contracting with key opinion leaders, laboratory programs (eg ADA-SCID), outside consultants as needed to enhance and propel forward key Medical Affairs initiatives as well as in support of Leadiant Project developments.
Regulatory & Compliance
- Work closely with Chief Compliance Officer and Drug Safety department to ensure compliant activities at all levels. Lead or delegate lead as medical reviewer, including but not limited to: Medical Review Committee, Promotional Review Committee, Grants Review Committee, IIT Review Committee, Labeling Committee.
- Oversee compliance with drug safety reporting throughout Medical Affairs department.
- Ensure that Medical Affairs operations follow all policies and procedures; ensure proper record keeping of applicable activities (e.g., IITs).
Specific Job Knowledge, Skill And Ability:
- Must have an MD, with 5+ year’s relevant scientific and clinical experience including but not limited to Institutional Review Board leadership, Clinical trials experience, performance as a key opinion leader in rare disease.
- Demonstrated effectiveness operating in an entrepreneurial environment with complex regulatory requirements, and a proven ability to work with all levels of management and employees.
- Excellent written, oral and presentation skills, with the ability to prioritize issues and allocate resources while applying sound business judgment.
- Actively drives strong teamwork and collaboration with an enterprise-wide perspective.
- Demonstrated ability to solve problems with innovative solutions along with strong organizational skills.
- Willingness to re-locate to the Gaithersburg, MD area preferred and/or ability to travel to Gaithersburg several times a month as needed and must live within driving distance of Leadiant home office.