As a true expert in the responsible TA, the 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 products in the respective Therapeutic Area (TA). She/He 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. This is internally and externally a highly visible role. The Specialty TA encompasses Hereditary Angioedema, Critical Care Acute Bleeding, and Congenital Respiratory Alpha 1 Antitrypsin Deficiency.
The position holder will:
- Ensure that accurate and robust TA/product related medical-scientific knowledge and clinical expertise, is appropriately communicated through scientific exchange with Key Opinion Leaders (KOL’s).
- Determine relevant gaps in the prioritized medical and scientific topics and create and implement state-of- the art initiatives to address them.
- Leverage in-depth scientific knowledge and KOL relationships to identify opportunities for scientific growth.
- Partner with, acting as the CSL Behring medical spokesman, and leverage KOL relationships in the medical and scientific community to develop and execute medical strategy.
- Possess a high awareness of patient needs, current therapeutic practices and new therapeutic trends in the US market.
- Function as the internal medical expert supporting sales and marketing in developing strategies and implementing tactics.
- Ensure the 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 Specialist (s).
- Partner and collaborate with the global TA leads representing both Pipeline and In-line products, International Medical Affairs, CRD, R&D, Global Clinical Safety & Pharmacovigilance (GCSP) and will serve on the Safety Management team for key US products.
Main Responsibilities and Accountabilities:
- Develop, implement, guide, and communicate the company’s Medical Affairs strategy and activities for the evolving assigned TA franchise. Drive the TA scientific agenda by focusing and aligning resources with key priorities in the region and globally.
- Set the scientific strategy for MSL field activities and KOL advocacy plans to build and maintain critical relationships and knowledge management for the responsible TA. Work closely with the TA Field Team Leader (s) to ensure effective and compliant execution of plans.
- Serve as the lead scientific and clinical expert in the assigned TA(s). 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 monitor and evaluate medical literature for potential impact on CSL Behring products and initiatives. Ensure that all Medical Affair staff working in their TA are current in their knowledge of relevant CSL sponsored clinical trial data and medical literature.
- Set the strategy for US Medical Affairs supported research (Investigator-initiated studies, Phase IV, Publications Grants) and ensures that this research is scientifically accurate, of high quality, relevant to key products needs and are completed on schedule and within budget.
- 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 are current, accurate, balanced, and useful to health care providers. Anticipate 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, MOSs, Field team leaders, and MISs). Serves as backup to MIS for promotional and educational materials working through the PRC and Medical Legal Review (MLR).
- 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 TA 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 TA 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.
- Partner with and share expertise with the global functions of Medical Affairs, ABC, 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.
Position Qualifications and Experience Requirements:
Education & Experience
- MD or DO is required, with residency training
- 12+ years of experience in the pharmaceutical industry and healthcare.
- Prior Medical Affairs experience is required; experience leading and managing teams in a global organization preferred.
- A strong Therapeutic Area knowledge and experience preferred.
- Previous interactions or relationships with US based KOLs, Healthcare providers, regulatory agencies, and academic institutions within the TA preferred.
- Possess the ability to conduct professional and compassionate interactions in serious disease-state physician and patient populations.
- Demonstrated excellent communication skills; be able to communicate and teach others complex scientific information and credibly manage informal and formal scientific conversations and presentations.
- Develops scientifically credible and respected effective working relationships with both internal and external customers
- Searches, reads, interprets, and conveys pertinent medical literature in the relevant therapeutic areas and establish self as a valuable resource to both internal and external customers.
- Cultivates collaborative working relationships between Medical Affairs and cross-functional team members.
- Maintains a high level of ethical and compliance standards.
Competencies
- Accountability
- Analytical thinking
- Collaboration and Team Work
- Conflict resolution
- Communication - Impeccable oral, written, presentation, and interpersonal skills
- Results and Performance-driven
- Sense of Urgency
- Strategic thinking/agility
Our Benefits
CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.
Please take the time to review our benefits site to see what’s available to you as a CSL employee.
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.
We want CSL to reflect the world around us
As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.