Are you ready to build the future product pipeline in a high-impact, strategic leadership role? The Senior Director of Medical Affairs, Cardiovascular & Renal (CVR) in Global Medical Affairs at CSL Vifor is responsible for the development and execution of global medical affairs strategies and tactics across the entire CVR Therapeutic Area (TA). These responsibilities are primarily focused on the pipeline and working closely with R&D and Commercial Strategy at the TA Leadership Team (TALT) membership level. This role works closely with regional and country teams to ensure global strategies and tactics are pulled through into the market and that impactful regional and country input from major markets are represented in global strategies. This role is also a key member of the CVR Therapeutic Area Leadership Team (TALT), and CSL Vifor Global Medical Affairs Leadership Team (MALT), contributing to the cross functional development of TA strategy and individual global product strategies.
Main Responsibilities and Accountabilities:
1. Develop and implement global medical affairs strategies and tactics for all products in the TA ensuring optimal value and access. This includes 5-year strategic medical affairs plans containing research strategies and tactical execution plans.
2. Develop comprehensive “go to market” medical affairs strategies, aligned with regions and countries, for all pipeline products in the TA which includes:
- Disease awareness
- KOL engagement
- Advisory boards
- Comprehensive publication plans
- Congresses including symposia
- IEGP and IIS strategy
- CME / IME
- Medical training for internal and external stakeholders
- Research (including RWE, Phase 4 and beyond clinical studies, PASS)
- Medical affairs input to Research and Development activities
- Business Development for pipeline expansion and collaborations
3. Work closely with clinical development to ensure study protocols will deliver on TPPs to provide data necessary to address unmet needs and focus on value and access not just registration. Ensure optimized labels for product launches globally and drive the collection of real-world data to continue to support products post launch including label updates.
4. Provide global strategic medical affairs expertise to the TA and participate in the cross functional development of TA strategy and individual product plans as a TALT member. Ensure deep understanding of the diseases we are currently or planning to participate in.
5. Work closely with regions and countries to ensure pull through of global tactics and sharing of best practices for all products, both in-line and pipeline, across the TA.
6. Lead the scientific interactions with the external medical community and internal medical affairs teams at the regional and country level. Develop and maintain relationships with KOLs and patient advocacy groups.
7. Determine the research gaps and prioritize areas of interest for Investigator Initiated Studies (IIS’s) and other types of collaborations across the TA. Responsible for medical and scientific evaluation of IIS and collaboration requests ensuring alignment with the research priorities. Oversight of all IIS’s within the TA.
8. Facilitate compliant collaboration, medical insight sharing and aligning strategies with TA marketing, market access, analytics and other key global commercialization functions.
8. Manage the Medical Affairs budget for the TA.
9. Has responsibility for oversight and effective management of all team members (i.e. direct reports) to include but not limited to the following:
Annual objective setting
Mid-year and end of year reviews; Coaching and counseling as appropriate.
Employee development. To include ensuring all leaders have development plans in place
Recruitment, selection and development of talent.
Managing, directing & measuring work on an ongoing basis.
Provides timely constructive feedback to ensure quality of work meets or exceeds company standards.
Position Qualifications and Experience Requirements:
Doctor of Medicine
12+ years of relevant experience in the pharmaceutical/biotechnology or healthcare industry or 12+ years relevant academic experience.
At least 5 years of medical affairs experience.
Strong TA (cardiovascular and renal, rare nephrology experience preferred) knowledge and experience with product launches and interactions with regulatory agencies preferred.
People management experience highly preferred.
Optional: MBA, Training in Biostatistics and Epidemiology, Public Health (MPH)
Travel : Willingness and flexibility to meet overseas travel requirements
This role can be located in King of Prussia, USA or Zurich, Switzerland.
Our BenefitsCSL 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 BehringCSL 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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