Head, Endocrinology Medical Affairs job in Princeton
|Employer:|| Novartis Pharmaceuticals|
|Category:||Research and Development|
|Job Type:||Full Time|
|State:||New Jersey (NJ)|
The Head of Endocrinology Medical Affairs provides strategic direction and medical/scientific leadership, and is responsible for developing, implementing, guiding and communicating Sandoz' Medical Affairs strategy and activities for the endocrinology franchise. He/she will have patients' interests as a primary mission which, as a consequence, produces product and enterprise success. The individual will, in partnership with other US Medical Affairs functions, lead the development of all endocrinology medical affairs strategies related to medical and scientific operations, publications/communications, medical expert engagement, medical affairs studies, investigator-initiated research programs, third party collaborative research. He/she will partner with other functions, including commercial, product development, and business development & licensing (BD&L), to plan out the short and long term strategy for the endocrinology business in the US. He/she will provide medical subject matter expertise nationally in support of Sandoz' endocrinology products, and will serve as the internal SME. The Head, Endocrinology Medical Affairs will also provide medical input into endocrinology medical/clinical due diligence activities in support of BD&L. Additionally, he/she will collaborate and work closely with the Global Medical Affairs organization to ensure alignment with global strategies. He/she will support an excellence-oriented and customer-focused culture, fostering enterprise leadership, innovation, cross-functional collaboration and team work.
1)Implement the Endocrinology Medical Affairs Strategy
•Develop the endocrinology medical affairs strategy in support of Omnitrope; ensure alignment with Global Medical Affairs, and support of the brand strategy.
•Oversee the field Medical team of Medical Science Liaisons supporting Omnitrope.
•Partner with Commercial to provide strategic medical insights to shape the portfolio strategy.
•Support, iterate and innovate a communication strategy which properly presents the value of products and science.
•Ensure integration and optimization of the communication strategy at the portfolio level. Execute the communications plan supporting the scientific needs and core strategy (i.e. planning for medical society presence, abstracts, and publications, supporting CME, writing of abstracts/publications, as appropriate and required).
•Strategic medical and scientific input and day-to-day advice to the commercial team and other relevant functions.
•Maintain clinical, scientific, and technical expertise in endocrinology, including relevant disease states..
•Ensure operational efficiency and effectiveness of all aspects of the business function. Manage budget to prioritize highest impact opportunities.
•Partner with Global Development to set strategic direction for Medical Affairs across development and lifecycle management activities. Provide key strategic input from a US perspective on global clinical development plans.
•Drive the therapeutic area growth agenda by focusing and aligning resources with key priorities in the US with other functions and Corporate/Headquarters groups.
•Collaborate with Regulatory Affairs to assist in the development of the regulatory strategy, including regulatory stakeholder management and submission strategies, if relevant. Support label negotiations and other FDA interactions.
•Provide strategic input and medical due diligence to BD&L activities where warranted.
•Provide direction and input into the development of key external stakeholder identification and engagement plan, in collaboration with field medical affairs teams and other relevant CDMA stakeholders.
•Drive the development of the engagement strategy for key stakeholders
•In collaboration and alignment with medical leadership, drive the activities and field tactical plan of the Medical Science Liaison (MSL) team
•Establish and maintain strong working relationships with key external stakeholders (medical experts, medical societies and managed care organization clinical/medical stakeholders) within the therapeutic area; foster effective and compliant working relationships and collaborations between Sandoz and key external stakeholders; ensure alignment and collaboration with other customer-facing CDMA teams.
•Oversee the planning and implementation of external sounding boards, including Scientific Advisory Boards and Steering Committees; create, channel and focus the work product of external sounding boards.
•Foster effective and compliant working relationships and collaborations between Sandoz and key external stakeholders.
•Gather clinical and scientific insight for current and future products through the attendance at scientific, technical, and regulatory meetings.
•Foster the ongoing education of the medical community by supporting efforts for funding independent CME programs and appropriately responding to unsolicited requests.
•Represent Sandoz with professionalism, credibility and integrity at select national and international meetings.
3)Direct/support data generation activities
•Oversee/guide the design, conduct, oversight, analysis and reporting of Medical Affairs clinical trials. Ensure timely submission and delivery of high-quality clinical trial documentation, implementation and execution.
•Provide guidance and counsel to associates and stakeholders to assure all activities are conducted according to the highest standards of ethics and compliance, and Legal policies and standards.
•Guide HE&OR and RWE projects in support of the endocrinology portfolio
4)Collaborate with and support the medical affairs field team and medical services and operations team
•Cultivate an inclusive, high performance environment that values and leverages diversity of thinking, style and experiences.
•Reinforce an atmosphere that attracts, develops, retains and promotes diverse, top scientific and clinical talent.
•Guide/oversee the medical and scientific training of internal staff (Medical Science Liaisons, Sales, and medical information staff) on products and disease related aspects.
This position requires frequent global and domestic travel (up to 25%).
MD, DO, MD/PhD
Board certification in Endocrinology or Internal Medicine preferred.
•At least 7 years pharmaceutical industry experience
•Experience in the design/implementation of medical affairs studies
•Strong background in endocrinology and biologics
•Experience in Endocrinology
•Historic clinical practice in relevant therapeutic area preferred
•Effectively present scientific and medical information before large and small audiences
•Translate complex scientific/medical concepts to audiences with differing scientific and technical knowledge
•Practical knowledge of Good Clinical Practices and regulatory requirements
•Excellent written and verbal communication skills
•Proven ability to establish productive and compliant professional relationships with key opinion leaders and medical/scientific professional societies
•Team player in a multidisciplinary, cross-cultural environment, high level of flexibility
•Successful experience in a matrix environment
•High attention to detail
•Innovative, creative and critical thinking
•Excellent computer skills (Microsoft Office; MS Excel, MS PowerPoint, and Adobe Acrobat)