Country Head Medical Affairs at Novartis

Summary

The Country Medical Affairs Head is the lead country medical representative, responsible for adopting and executing the near- and long-term medical strategy coming from Global/International, forging bold strategic partnership with the healthcare communities and governmental entities. Manage and develop the overall performance of the medical unit in country. Drive best-in-class launch preparedness and launch execution (incl. ensuring precision medicine availability at launch and overcoming local data gaps for HA Submission - when applicable) As a core member of the South African IM Leadership Team this person is accountable for the creation of the functional medical strategy for the country and ensures its execution, by leading all clinical and medical aspects of in-country activities and all associated resourcing and performance aspects.

About the Role

Major accountabilities:

Strategy and Strategic advice:

• Raises country medical and clinical interests into global and regional strategy and prelaunch planning, starting at DDP by providing timely and strategic feedback to GPTs. This shapes the development program earlier and ensures IDPs include integrated (Integrated Evidence Plans [IEPs]), diverse data available at launch to support own local reimbursement and clinical implementation.
• In line with the evolving healthcare ecosystem, proactively and strategically builds and strengthens partnerships beyond the traditional healthcare professionals and organizations. Identifies opportunities for joint value creation deploying new engagement models of broader reach.
• Oversees that all local studies are developed and timely executed based on country evidence gaps. Accountable to ensure adherence to all governance, compliance, quality, and safety measures in accordance with local standards in implementation. Ensures effective communication plans in place for external stakeholder education and advocacy.
• Ensures Implementation Science plans in place early and holistically to systematically shape health policy and practice guidelines converging clinical innovations and treatments into better standards of care via better disease management. Depth of insight and understanding of local Healthcare ecosystem and contextual system challenges to ensure early reimbursement and patient adherence.
• Establishes a clinical excellence and treat to target mindset across the healthcare system through medical education activities including preceptorships, clinical excellence collaborations (e.g. heart failure or breast cancer clinics) and continuous medical education-style events.
• Role models ethical standards and contribute proactively to a credible image for Novartis in the country. Represent Novartis at key external governmental, scientific, clinical and medical events to educate, advocate and support innovation and evidence-based research.

Stakeholder Engagement

• Engages with key patient associations, academic societies, patients, payers and reimbursement bodies as well as the relevant healthcare systems, to harness opportunities and share ownership in transforming the clinical practice with optimal access and better outcomes for real world patients.
• Builds and facilitates close cross-functional equal partner collaboration with key internal stakeholders, co-creating and leading where necessary. Function as the key medical interface to Country President, Value & Access, TA Heads and BE&E Heads or similar position, GDD representatives, Public Affairs, and compliance teams as well as related Regional teams. In partnership with country Regulatory Affairs, develops and manages long-term relationships with local Regulatory agencies and relevant medical societies.
• Reactively supports HCP requests for deep clinical and scientific discussion around our therapy areas and products at all stages of the product lifecycle.
• Ensures BeSure approval for events/materials/initiatives used by the commercial, medical, access and TMO organization. Collaborates to upgrade capability of investigators, Ethics Committees etc.

Capability Building and Internal Alignment

• Encourages earlier (starting at DDP) initiation of innovative integrated evidence generation strategies, novel research activities, and local collaborative and impactful partnership engagements. Supports utility of RWE innovative study designs and exploratory trials (where applicable) across TAs to accelerate patient access; oversight of Managed Access Programs (MAPs), IITs etc.
• In close collaboration with Global Drug Development (GDD), cultivates strategic and effective co-creation and collaboration plans, for allocation and execution of clinical trials within the country, as necessary. Incorporates local portfolio prioritization to shape GDD trial strategies and resource allocation. (only applicable for key markets).
• Encourages utility of more innovative digital technologies for more meaningful and impactful engagements and data generation and utilization.
• Leads pre-launch and launch strategy and activities for new assets, achieving high levels of scientific engagement amongst key defined external stakeholders. Collaborates closely with cross-functional launch and brand team to include insights from advisory boards and other key medical engagement initiatives.
• Run Medical Information services to the highest standards.
• Lead and manage a team of field based Medical Scientific Liaisons
• Maintains and drives the standards of medical and scientific excellence in the country through recruitment selection, deployment and capability upskilling of agile innovative and collaborative talent together with P&O, in accordance with Novartis Leadership Standards
• Owns and optimizes medical resources and allocation: Advocates early resourcing (where and when appropriate), while ensuring cost adherence in spend of Medical Affairs trials, activities and resourcing. Ability to articulate and defend priorities and needs of medical with strong influencing skills. Recruits, hires and develops talent while maximizing potential for leadership.
• Ensures that Target Patient Population Outcomes (TPOs) are updated and relevant, and that they are being tracked, resourced, and impacted at CPO level with appropriate regional and global support for all franchises
• Drive the spirit of “ONE Team” across all functions (TA first) by supporting a team approach to focus on our patients, payers and customers as our top priorities.
• To report any Adverse Event or technical quality complaint within 24 hours from the receipt to the DS&E safety or Complaint Coordinator in accordance with the valid local SOPs

Key performance indicators:

• Recruitment, development, and retention of Medical Top Talents in the country as measured by effective OTR process and Employee Engagement Survey
• Execution of Medical Affairs strategy as per agreed KPIs
• Adherence to legal and regulatory compliance criteria as per relevant legislation and Novartis Policies; Code of Conduct as per policy.
• Optimal alignment of execution with GDD and commercialization/Patient access needs of the CPO.
• Improvements for patient journey as defined by KPIs
• Continuous operational improvements to enhance quality and efficiency in all areas of responsibility.
• Implementation of Medical capability building and innovative medical initiatives
• Medical Affairs / Program budget execution vs. target.
• Target patient population outcomes progress.

Minimum Requirements:

Education:

• Medical Doctor (MD) preferred, PhD or PharmD may be considered with appropriate and extensive experience

Work Experience & Skills:

• ≥8 years of relevant pharmaceutical industry experience
• ≥4 years people management and development experience in a matrix environment
• Relevant experience acquired at pharmaceutical companies, HTA, physician associations or health care consultancy companies or equivalent experience.
• Working knowledge of pharmaceutical market and healthcare systems
• Proven ability to network with all levels of external stakeholders and work in matrix environment distilling and prioritizing market needs and deliverables.
• Strong leadership and influencing skills in a matrix; articulate vision for MA in the Country; build externally focused culture.
• Excellent writing, communication, and interpersonal skills
• Strong solution-orientation and business acumen
• Operate with mutual respect and integrity, collaboration and embrace diversity
• Deep understanding of drug development and approval processes, including experience designing and/or executing clinical studies.
• Thought leader in all medical core and game changing competencies.
• Scientific/medical research experience with demonstrated record of scientific/medical publication desirable.
• Excellent understanding of local, regional, and country regulatory standards and processes, as well as relevant (country-specific) ethical and legal guidelines. International/global experience desirable
• Significant experience of risk management