Job Description Summary
Acts as the enterprise medical voice for the asset or disease area across the lifecycle (early to in-market) and strategic partner to Research, Development, US and International TA, peri- and post-launch, ensuring MA input is reflected in the asset development plan. Ensures that medical & scientific input is reflected to shape the early portfolio (pre TDP). Ensures medical practice and patient needs are reflected in the clinical development plans leading to optimal regulatory approval & patient access and supports the clinical adoption worldwide.
Represents a credible and cohesive medical voice, integrating US and International Medical Affairs input, to Global Programs for across the life cycle.
Develops/ owns Integrated development plan and provides input into development while ensuring US and Int'l medical perspective is reflected.
The Executive Director is responsible for the implementation of medical strategies for early programs globally with focus on innovative evidence solutions including interventional studies, NIS and RWE studies and implementation science projects. Lead Integrated Evidence Packages in situations with higher scientific complexity and potential regulatory challenges. Will manage the most complex assets and those that potentially will require deeper pharmacovigilance expertise. Will 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.
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
Location: London, UK/Dublin, Ireland/Barcelona, Spain / #LI-Hybrid
Job Description
Major Accountabilities:
- Lead development and execute medical affairs strategy for priority programs including transformative tactics such as: research/population health, innovative partnerships and integrated evidence plans
- 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.
- Provide proactive input to Development on potential new therapeutic indications, to enrich Registration Programs and to consider new therapeutic opportunities.
- Ensure that Patient Access programs are supported for all brands within the GMA and delivered with full compliance.
- Ensures GMA activities are designed and executed in compliance with company policy guidelines and highest medical quality standards.
- Provide proactive medical input to asset lifecycle management to consider new therapeutic opportunities.
Must have:
- MD, Neurologist (Preferred) or PhD/PharmD in Neuroscience/ Health Sciences. Specialist Degree or specialist qualification in Gene therapy related to discipline for which is responsible is an advantage
- 6+ years in Pharmaceutical Industry experience in Medical Affairs and/or Clinical Development
- Critical thinker and with ability to navigate uncertainty without major supervision.
- Fluent oral and written English; Other relevant languages are an advantage
- Strategic mindset and able to establish credibility and influence across a range of diverse stakeholders in a matrix organization to drive change.
- 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
- 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
- Agile mindset & ability to lead in an agile organization across Disease Areas
- Firm working knowledge of GCP, scientific and clinical methodology, protocol designs, management and regulatory requirements for clinical studies designated for review by regulatory authorities.
Preferred
- Highly preferred: Neuromuscular, Rare Disease, siRNA, Gene Therapy, 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 TA of interest is strongly desired
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.
Skills Desired
Clinical Practices, Clinical Research, Drug Development, E-Learning, Influencing Skills, Job Description, Leadership, Medical Communication, Microsoft Access, Patient Care, PCB (Printed Circuit Board), Personal Development, Pharmaceutics, Pipeline (Software), Product Placement, Regulatory Compliance, Software Release, Strategic Direction, Well-Being