The purpose of the Therapeutic Area Head, Director position (TAH) is to lead the development and execution of Medical Affairs strategies and tactics in support of the US market to demonstrate the value of CSL Behring’s licensed and in line products in the assigned Therapeutic Area (TA). This is internally and externally a highly visible therapeutic area expert role.
As the only true US expert in the responsible TA, the TAH, will provide the necessary up to date understanding of the US medical practice to internal CSLB stakeholders and align this knowledge with the global understanding that CSLB is aiming for in the field. -Will ensure that accurate and robust medical-scientific knowledge and clinical expertise, is appropriately communicated through scientific exchange with Key Opinion Leaders (KOL’s) regarding CSL Behring products for the TA area of responsibility.
-Will determines the relevant gaps in the prioritized medical and scientific topics, creates and implements state of the art initiatives to address them.
- Leverages their in depth scientific knowledge and KOL relationships to identify opportunities for scientific growth.
- Partners with, acts as the CSLB medical spokesman and leverages their KOL relationships in the medical and scientific community to develop and execute medical strategy. The position holder will have a high awareness of patient needs, current therapeutic practices and new therapeutic trends in the US market. The position holder functions as the internal medical expert in supporting sales and marketing in developing strategies and implementing tactics.
- Responsible for increasing quality and relevance of all Medical Affairs led research (Investigator-initiated studies, Phase IV, Publications Research Grants) and publications.
- Provides Promotional Review Committee (PRC) oversight of the Pharm D Medical Information Scientist(s).
- Partner and collaborate with and be the TA lead representing NA Medical Affairs with the global functions of Commercial Development, CRD, R&D, Global Clinical Safety & Pharmacovigilance (GCSP) and will serve on the Safety Management team for key US products.
- Responsible for developing, implementing, guiding and communicating the company’s Medical Affairs strategy and activities for the evolving assigned Therapeutic Area franchise. Drive the Therapeutic Area scientific agenda by focusing and aligning resources with key priorities in the region and globally.
- Serves as the lead scientific and clinical expert in the assigned therapeutic area(s). As the TA expert will provide input on labeling and regulatory strategy. Maintains in-depth understanding of disease states, assigned products, competitors, marketplace, related medical areas and regulatory guidelines. Closely monitors and evaluates medical literature for potential impact on CSL Behring products and initiatives. Insures that all MA staff working in their TA are current in their knowledge of relevant CSL sponsored clinical trial data and medical literature.
- Leads US publication planning function (pre and post launch) in assigned therapeutic area in collaboration with the global publication plan to drive TA Scientific agenda in alignment with strategic objectives.
- As the TA expert collaborates with Medical Information Specialists (MIS) to assure that standard response letters that are up to date, accurate, balanced and useful to health care providers. Anticipates queries that may arise with new product launches and establishes high quality and timely training of the entire field and in house Medical TA team (MTAL, MSLs, Field team leaders, MSMs and MISs). Serves as backup to MIS for promotional and educational materials working through the Promotion Review Committee and Medical Legal Review.
- Leads the planning and execution of Scientific Advisory Board meetings. Leverages scientific knowledge and KOL relationships to identify opportunities for activities leading to scientific advancement. Represent Company at scientific meetings.
- Acts as the lead therapeutic area medical expert and partner to Business Team (s) within US Commercial Operations and is responsible (in collaboration with the MTAL if applicable) for developing, executing, and communicating the cross functional Medical Affairs strategy and tactics for the evolving Therapeutic Area franchise.
- Develops and delivers scientific presentations to internal and external audiences (healthcare professionals, consumers, patient advocacy and support organizations, managed care organizations, sales force, etc.). Oversees and provides quality assurance for presentations and scientific exchange conducted by field-based MA team.
- Sets the scientific strategy for MSL field activities and KOL advocacy plans to build and maintain critical relationships and knowledge management for the responsible Therapeutic Area.
- Responsible for setting the strategy for US Medical Affairssupported research (Investigator-initiated studies, Phase IV, Publications Research Grants) and insures that this research is scientifically accurate, of high quality, relevant to key products needs and are completed on schedule and within budget.
- As the therapeutic area medical expert representing NA Medical Affairspartners with and shares their expertise with the global functions of Commercial Development, CRD, R&D, Regulatory affairs, Global Clinical Safety & Pharmacovigilance and may serve on the Safety Management team for key US products. Provides key strategic input to shape the portfolio strategy and global clinical development and risk management plans. Participates in global marketing, medical, and training meetings, including new product launches and publication planning.
- Collaborates with Corporate Communications to function as primary contact for US Commercial Operations Medical Affairs with national and international patient associations and organizations (organizations vary by therapeutic area). Education
Doctor of Medicine, with residency training preferably in North America. Exceptions to the North America requirement may be made for expertise (academic and clinical or pharmaceutical) in the applicable TA.
ExperienceMinimum 10 years in the pharmaceutical or healthcare industry. Prior Medical Affairsexperiencerequired. Strong TA knowledge and experiencepreferred. Previous interactions or relationships with US based Key Opinion Leaders, Healthcare providers, regulatory agencies, and academic institutions within the Therapeutic area preferred.