摘要
#LI-Hybrid
Join Our Vision: At Novartis, we are on a transformative journey in cell and gene therapy, pushing the boundaries of medical innovation building on our heritage pioneering this field.
We are currently seeking an experienced and visionary Executive Director to provide strategic leadership to Cell and Gene (C&G) Therapy within our Global Oncology Medical Affairs department.
In this critical role, you will lead the C&G Global Medical Directors and act as the C&G enterprise medical voice for the assets and or disease areas across the lifecycle (early to in-market) and strategic partner to Research, Development, US and International Medical Affairs for all assets on this platform.
You’ll ensure that medical & scientific leadership input is reflected to shape the early portfolio (pre TDP) and that medical practice and patient needs are reflected in the clinical development plans, leading to optimal regulatory approval & patient access, and support the clinical adoption worldwide.
The Executive Director is also responsible for the implementation of medical strategies for early programs globally with a focus on innovative evidence solutions including interventional studies, NIS and RWE studies and implementation science projects.
This role will require you to develop / own the Integrated Evidence Plans (IEP) and provide input into development while ensuring US and Int'l medical perspective is reflected.
The Executive Director will also act as a subject matter expert in the development of the overarching strategies, providing inputs during design and along the end-to-end execution of programs across different disease areas. You will provide leadership and deep medical expertise in the TA, pivoting support based on business priorities and will represent GMA with senior stakeholders when needed.
About the Role
Key Responsibilities:
- Lead development and execute medical affairs strategy for priority programs including transformative tactics such as: research/population health, innovative partnerships and integrated evidence plans and proactively provide input to Development on potential new therapeutic indications, to enrich Registration Programs and to consider new therapeutic opportunities.
- Co-develop plans for evidence generation, medical launch plans, MSL / Field Medical Affairs strategy, medical education programs, scientific publication planning and Medical Expert network development with TAs
- Co-own the development and implementation of innovative education and scientific communication plans for external stakeholders.
- Financial tracking to ensure timely and cost-effective development & execution of medical activities.
- Partner with Development, S&G, US and International cross-functions to shape portfolio early and diversify evidence to achieve broad access at launch and to enhance impact on clinical practice for priority programs.
- Represent GMA around prioritized portfolio with internal and external audiences, in collaboration with TAs including the investment, medical and regulatory communities, as well as pharmaceutical or biotechnology industry collaborators/partners.
- Represent “the voice of the patient” internally and evaluate factors relevant to a patient’s informed decision making.
- Ensure GMA activities (incl. Patient Access programs) are designed and executed in compliance with company policy guidelines and highest medical quality standards.
Requirements:
Must have:
- MD (Preferred) or PhD/PharmD in Health Sciences. Specialist Degree or specialist qualification related to discipline for which is responsible is an advantage.
- Demonstrable experience in Pharmaceutical Industry within Medical Affairs and/or Clinical Development. Firm working knowledge of GCP, scientific and clinical methodology, protocol designs, management and regulatory requirements for clinical studies designated for review by regulatory authorities.
- Critical thinker and with ability to navigate uncertainty without major supervision. Strategic mindset and able to establish credibility and influence across a range of diverse stakeholders in a matrix organization to drive change.
- People management experience and skills; ability to truly collaborate across functions and markets: serve-partner-co-create. Able to navigate in an environment of shared outcomes and cross-business accountabilities.
- Deep understanding of health care systems and key external stakeholders and a strong track record of delivery focus for time and quality in medical affairs projects. Successful development and implementation of innovative programs and processes.
- Understands unmet medical needs, generates the right evidence to fulfil them, uses innovative, multichannel communication formats for effective evidence dissemination.
- Credibility as peer expert with external stakeholders and an agile mindset & ability to lead in an agile organization across Disease Areas.
Preferred
- Highly preferred: Significant medical affairs early asset lifecycle, pre-launch and launch experience in Global organizations
- Experience in developing and executing “Best in Class” processes at scale
- Clinical trial research experience conducted in a pharmaceutical or equivalent academic environment in Oncology is strongly desired
Why Novartis?
Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy /people-and-culture
Benefits and rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Accessibility & Accommodation : Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
