A career with EMD Serono is an ongoing journey of discovery: our 50,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. EMD Serono is a business of Merck KGaA, Darmstadt, Germany.
Your Role: The Vice President, US Medical Affairs, Neurology & Immunology (N&I) will build and direct the Medical Affairs team for N&I. Working within approved corporate business strategies, develops and implements overall medical affairs plans for the products in development and marketed products in collaboration with Global Medical Affairs. Participates in WMSG groups for the immunology and neurology therapeutic areas providing the medical expertise for building business strategies, and develops proactive franchise plans emphasizing medical content. Provides ongoing information and strategic analysis on customer and market conditions, leads evaluation and approval of IST/IMG proposals, treatment protocol trends, and medical and technology developments. Responsible for the creation of programs, phase IIIb-IV clinical trials, scientific advisory boards and speakers programs to support the Immunology and Neurology products. Interacts closely with Medical Operations for the execution of such programs and clinical trials as well as Phase II and III clinical studies interacting with Clinical Development. Generates US publication plans supporting marketed and future products in line with the medical affairs plan for the therapeutic area. Manages all US Medical Affairs N&I programs and activities within corporate and FDA regulatory guidelines and approved budgets. Serves as a key member of N&I US management team in regards to strategic planning and interacts closely with regulatory affairs, medical information, product surveillance and clinical development. The position will involve extensive interaction with internal senior management, outside experts, corporate partners, key immunology and neurology thought leaders, and the FDA. Oversees the work of direct reports for the Promotional & Scientific Materials Review (PSMR) Committee for the evaluation of educational material and scientific publications for dissemination by MO. Responsible for the generation of the medical educational content to be delivered to KAMs and MSL/MLs for the N&I TA. Works very closely with Managed Markets for the medical support of our products through presentations and interaction with Health Care providers through P&T Committee presentations. Serves as member of the CMOâs management team under the Medical Organization.
KEY TASKS & RESPONSIBILITIES
- Responsible for building, directing and managing the N&I US Medical Affairs team.
- Additionally, the candidate and his/her direct reports will work closely with the clinical, commercial, business development organizations, and the global development teams to develop, implement, and deliver the designated product lifecycle plans.
- Provide inspirational leadership and focus to Medical Affairs team to assure delivery of key medical affairs objectives as related to Immunology and Neurology US Medical Affairs Balanced Score Card (BSC) and corporate objectives, and in a highly dynamic environment.
- Responsible for the management of the departmental budget under CMO oversight.
- Own and drive the Medical Affairs programs and related processes within the department interacting actively with Medical Operations.
- Integrate and influence N&I marketing & sales strategies, tactics and programs to accomplish medical affairs objectives.
- Personally develop and maintain key opinion leader relationships. Implement measurable policies regarding customer and product medical education within the team to assure a high level of customer satisfaction and compliance.
- Apply situational leadership styles to provide appropriate direction and support to direct reports, the unit and cross functional members that focuses efforts on achieving customer loyalty and EMD Serono results.
- Collaborate with other therapeutic areas to leverage medical affairs expertise and programs as appropriate.
- Directs the development, communication, and implementation of medical affairs programs, policies and procedures.
- Actively participates within cross-therapeutic area/ intra-company task forces.
- Ensure and lead close collaboration between the Medical Affairs departments and all other functions within the CMOâs Medical Organization.Â
- Assess human and capital resources of the Medical Affairs team continuously. Lead and conduct the performance management & merit process throughout the year for the medical affairs team; responsible for assuring medical affairs personnel are properly supervised, qualified, and trained to perform their jobs effectively.
- Coach, manage and provide individual job enrichment developmental opportunities to direct reports.
- Conduct field visits as appropriate.
- Other related duties as assigned.
- Responsible for direct leadership and management of all direct reports, indirect leadership and direction to MLs/MSLs under Medical Operations.
- Key member of Immunology and Neurology and the CMOâs Medical management team in regards to strategic planning and overall management of the therapeutic areas.
- Provide expertise and strategic leadership to the N&I US Medical Affairs team.
- Optimize the utilization of the available resources
- Apply and direct project management techniques and teamwork approach
- Expertise and strategic leadership in support of EMD Serono US goals and objectives
- Expert level of understanding in medical affairs, clinical development, sales, marketing, regulatory, and medical and sales operations, and project based organization and SOPs.
- Expert level of understanding in product launches
- Expertise and strategic leadership in support of N&I goals and objectives
- Develop and recommend strategies, develop and provide input for business plans
- Identify marketâs medical issues impacting the results of the TA and direct and coach staff on resolution of such issues
- Initiate and lead, as appropriate, activities to address cross functional issues within the N&I TA
Who You Are:
- Candidates should have an M.D. degree with board certification/eligibility in Medical Immunology and/or Neurology with significant experience in industry related drug development preferably with direct BLA or NDA filing experience.
- MBA strongly preferred
- Requires a minimum of 10-15 years director level or above medical affairs/ clinical experience in the pharmaceutical/healthcare industry with demonstration of successful results.
- Experience bringing multiple products to market in the Immunology and Neurology space
- Experience in drug development with in depth understanding of clinical trial design, clinical trial execution, regulatory requirements in N&I, and data analysis
- 6 - 8 years managing, leading and developing people required
- Expert knowledge of guidelines under which pharmaceutical companies operate (FDA, PhRMA, OIG, etc)
- Proven ability to act as a medical spokesperson for external audiences is required
- Experience in developing and leading a clinical or medical affairs team in changing competitive environment, changing product technology, and changing customer needs.
- Experience in working in an environment which successfully integrates all business unit functions.
- Demonstrated success in developing and managing strategic relationships with medical N&I experts and key thought leaders
- Knowledge and application of data sources, reports and tools for the creation of solid plans for which performance can be measured and evaluated
- Knowledge and application of business planning & leadership principles, such as data analysis, goal setting, action plans, monitoring tools, directive and supportive techniques to develop and implement action plans
- Possess strong business and financial skills. Has P&L experience or at least budget responsibility.
- Demonstrated ability to lead and influence teams. Must be able to manage a diverse work group, motivate them, and maximize productivity
- Excellent analytical, communication and presentation skills and solid experience in translating medical/ clinical information into medical affairs strategies.
- Position requires domestic and international travel up to 50% of time
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at come2emd.com
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.