The Therapeutic Area Head, Medical Affairs (TA Head) Executive Director, will 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 Immunology Therapeutic Area (TA) products. This is internally and externally a highly visible therapeutic area expert role.
As the only true US expert in the responsible Therapeutic Area, the TA Head, will provide the necessary up to date understanding of the US medical practice to internal CSL Behring stakeholders and align this knowledge with the global understanding that CSLB is aiming for in the field.
In this role the TA Head 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.
- Determine the relevant gaps in the prioritized medical and scientific topics, creates and implements state of the art initiatives to address them.
- Leverage their in depth scientific knowledge and KOL relationships to identify opportunities for scientific growth.
- Partner with, acts as the CSL Behring 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.
- Provide Promotional Review Committee (PRC) oversight of the PharmD 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.
- 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.
- Serve as the lead scientific and clinical expert in the assigned therapeutic area(s). As the TA expert, you will provide input on labeling and regulatory strategy. Maintain 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. Insure that all Medical Affair staff working in their TA are current in their knowledge of relevant CSL sponsored clinical trial data and medical literature.
- Lead 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.
- Collaborate 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 (Medical Scientists, MSLs, Field team leaders, and MISs). Serves as backup to MIS for promotional and educational materials working through the Promotion Review Committee and Medical Legal Review.
- Lead the planning and execution of Scientific Advisory Board meetings. Leverage scientific knowledge and KOL relationships to identify opportunities for activities leading to scientific advancement. Represent Company at scientific meetings.
- Act as the lead therapeutic area medical expert and partner to Business Team (s) within US Commercial Operations and is responsible for developing, executing, and communicating the cross functional Medical Affairs strategy and tactics for the evolving Therapeutic Area franchise.
- Develop and deliver scientific presentations to internal and external audiences (healthcare professionals, consumers, patient advocacy and support organizations, managed care organizations, sales force, etc.). Oversee and provide quality assurance for presentations and scientific exchange conducted by field-based MA team.
- Set 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 Affairs supported research (Investigator-initiated studies, Phase IV, Publications 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 Affairs, partner with and share 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. Provide key strategic input to shape the portfolio strategy and global clinical development and risk management plans. Participate in global marketing, medical, and training meetings, including new product launches and publication planning.
- Collaborate and support the Canadian Medical Affairs team as the Therapeutic Area medical expert.
- Collaborate 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).
- A graduate degree in the scientific field, a MD or DO is required, with residency training.
personal characteristics and key competencies
- A minimum of 12 years of experience in the pharmaceutical or healthcare industry.
- Prior Medical Affairs experience is required.
- A strong Therapeutic Area knowledge and experience preferred.
- Previous interactions or relationships with US based Key Opinion Leaders, Healthcare providers, regulatory agencies, and academic institutions within the Therapeutic area preferred.
- Possess the ability to conduct professional and compassionate interactions in serious disease-state physician and patient populations.
- Demonstrate excellent communication skills; be able to communicate and teach others complex scientific information and credibly manage informal and formal scientific conversations and presentations.
- Develop scientifically-credible and respected effective working relationships with both internal and external customers
- Search, read, interpret, and convey pertinent medical literature in the relevant therapeutic areas and establish self as a valuable resource to both internal and external customers.
- Cultivate collaborative working relationships between Medical Affairs and cross-functional team members.
- Maintain a high level of ethical and compliance standards.
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About CSL Behring
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.
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