Band

Level 6

Job Description Summary

The Global Medical Affairs team acts as enterprise medical voice across the asset lifecycle and leads the medical strategy for the therapeutic area. Develops/ owns IEP and provides input into development while ensuring US and Int'l medical perspective is reflected. 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. Based on extensive experience in drug development, MD will be able to 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. Acts a strategic partner to NIBR, Development, International Medical Affairs, US MA.

Location: London, UK/Dublin, Ireland/Barcelona, Spain / #LI-Hybrid

Job Description

Major Accountabilities:

Lead development and execution of medical affairs strategy for TA/Asset priority programs including transformative tactics such as research/population health, innovative partnerships and integrated evidence plans
Co-develop plans for evidence generation, 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
Prepare Scientific review committee submissions for TA assets
Partner with Development, S&G, US and International medical affairs, 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 direction and input into the development and implementation of successful reimbursement and market-access strategies
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

Requirements:

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
3+ 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 expertise, 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 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

Agility, Agility, Clinical Practices, Cross-Functional Collaboration, Data Analysis, Drug Development, Employee Development, Healthcare Sector Understanding, Health Sciences, Influencing Skills, Innovation, Inspirational Leadership, Integrated Evidence Generation, Medical Affairs, Medical Communication, Medical Education, Patient Care, People Management, Pharmaceutics, Priority Disease Areas Expertise, Product Launches, Product Strategy, Real World Evidence (RWE), Regulatory Compliance, Research Methodologies {+ 4 more}

Medical Director, Neuroscience, Global Medical Affairs

Job Description