Global Medical Director / Global Medical Science Director

Switzerland, Basel-City, Basel
United Kingdom, Hertfordshire, Welwyn

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Purpose and Scope

The Global Medical Director (GMD) /Global Medical Science Director (GMSD) is a core PDMA role that typically represents medical/clinical expertise in clinical research and medical practice in a given Disease Area (DA) or Therapeutic Area (TA). It very much focuses on understanding, anticipating, catalyzing and contributing to transformation of medical practice as related to a respective product (molecule or non-molecule/group of products/Disease Area [DA]). ‘GMD’ applies for qualified MDs/degrees, ‘GMSD’ for other life-science qualifications/degrees (e.g. PhD, pharmD). The GMD/GMSD leads and/or coordinates the medical strategy contributions to the ‘integrated strategy’ (which also includes market access and marketing components) and/or life cycle strategy for a respective product(s) DA. Timing can be as of first Target Product Profile (TPP) for a New Molecular Entity (NME) or a Line Extension (LE) or - where appropriate - earlier and in line with the Integrated Development and Commercialization Planning process and Integrated Evidence Planning process.

The post holder may be responsible for the development and execution of the evidence generation strategy for the assigned product(s)/DA, especially in view of ‘essential clinical practice data’ and ‘access’ needs that take into account key insights and perspectives from multiple medical community/healthcare ecosystem stakeholders (e.g. HCPs, patients, nurses and payers). The GMD/GMSD may also contribute to or lead the coordination of the overall ‘integrated evidence strategy and plan that encompasses the Clinical Development Plan (CDP) as well as data needs for market access and essential clinical practice.

The GMD/GMSD may be accountable and responsible as appropriate for the benefit/risk assessment  and may sign off of respective documents of the assigned product(s) in relation to Medical Affairs evidence generation and activities. They will stay abreast of internal and external developments, trends and other dynamics relevant for the assigned product(s)/DA to maintain a fully current view and perspectives of external influences (including e.g. Digital Health, personalization of medicine, patient- and healthcare ecosystem-centricity).

Depending on qualification, experience and role, they may have line/people management responsibilities; may have substantial matrix management responsibilities and may provide strategic and/or operational guidance to other Medical Affairs Professionals [e.g.  Global Medical Directors (GMD/GMSDs); and other members of the cross-functional global medical team. In accordance with ICH GCP E6 (R2) (2016): appropriately qualified medical expertise should be designated to advise on trial related medical questions or problems (e.g. medical monitoring). This may also apply to compassionate use matters. 



Core Responsibilities 

  • Medical Expertise and Strategy, Evidence Generation, Medical Dissemination, Medical Insights, Enabling of (internal) medical network and integrated community 

  • GMD/GMSD may perform one or more of the following activities depending upon areas and lengths of expertise, and/ or assignment to specific activities, product(s), or disease/therapeutic areas, taking into account dynamic and fit-for-purpose business needs and priorities and allowing for fluidity and adaptability

  • This may also include flexible compositions and adoption of other PD(MA) or potentially Pharma or Group (REDs) roles, or integrated (more function-agnostic) roles as needed and appropriate (e.g. Scientific Communications; Digital Health, Patient Partnership, Medical Field, Market Access, integrated strategy, DIA or other PD e.g. PHC, PDC, PDS, PDR) and compatible with business practice and compliance principles

Medical Expertise and Strategic contributions; Medical Insights

  • Provision of Medical Expertise relevant for products(s)/DA; familiar with the principles of clinical research and settings of (routine) medical practice. Contributes to and/or leads Medical landscaping analysis (current and anticipated future clinical practices, competitive landscape, new end point trends, medical data needs to inform clinical practices, gain and maintain access, and to shape ecosystems  ..) and Medical strategy components ( evidence generation; dissemination; medical insights; enabling of global medical network and business community) of integrated business strategy and plans.

  • Collaborates closely with relevant business partners on the integrated strategy and plan.

  • Support or lead of Clinical/Medical Insights generation activities


(Integrated) Evidence Generation Strategy/ pre-Approval Access:

  • Contributes or leads the (PDMA) evidence generation strategy planning and execution relevant for the product(s)/DA including integrated Healthcare Solutions incl. (but not limited to) identifying medical and access gaps/ needs as part of the overall integrated evidence strategy and ensuring appropriate set-up in the context of future healthcare ecosystems.

  • Leads and/or contributes to the strategy of the integrated evidence generation activities relevant to Medical, incl. clinical studies, Investigator Initiated Studies (IIS), real-word-data, scientific research collaborations,  and others 

  • Provides oversight of evidence generation activities including medical affairs-driven studies (global, affiliates) for assigned product(s)/DA

  • Identifies potential medical interests/opportunities for new indications/ line extensions according to scientific rationale, medical need, and good understanding of the actual and anticipated future directions of medical practice 

  • Assesses the needs and coordinates compassionate use/ pre-approval access strategies and plans of the assigned product(s)/DA


Market Access / Healthcare Ecosystems: 

  • Provides medical and functional expertise and input into the product(s) market access strategies and related operational plans and teams; may guide others in their respective responsibility

  • In collaboration with relevant internal/external partners (e.g. global access, worldwide medical community, patient partnership, real-world operating model and PHC) identifies the evidence generation needs/gaps in order to obtain and maintain patient access to payer/healthcare ecosystems, and ensures integration of needs/gaps into the integrated evidence generation strategy, as well as into relevant medical strategy contributions

  • Maintains a broad overview of access evidence requirements and external value/decision drivers relevant for the assigned product(s)/DA 

  • In collaboration with relevant internal/external partners (e.g. affiliates, PHC CoE,  patient partnership, patient associations, PDMA digital RWE leads) identifies patient and caregiver needs and drives implementation of integrated, clear value add, solutions such as digital health and digital patient monitoring solutions into ecosystems


External Collaborations:

  • Develops, advances and maintains TAE (and other stakeholders of the medical community/ healthcare ecosystems as appropriate) interactions and collaborations, incl. those aimed to set up and conduct evidence generation activities as well as medical insights to inform strategy

  • Represents Roche in peer-to-peer interactions with external collaboration partners, including  patient-company interactions


Compliance:

  • Responsible for acting in line with legal, regulatory, industry and company standards and codes of practice (such as Roche Code of Conduct and any other Roche directives and guidelines)


 

Extended Responsibilities, Activities, potential Roles

Execution of Evidence Generation Activities:

  • Accountable for (PDMA) evidence generation activities for a product/DA, including risk benefit assessment and medical monitoring in all medical affairs-driven data generation activities, e.g. interventional studies 

  • Designs, reviews and signs off on study concepts, synopsis and protocols of PDMA studies 

  • Reviews affiliate study synopses and signs off affiliate studies (as needed and appropriate) 

  • Conducts review and approval (as needed and appropriate) of investigator initiated studies (IIS), research collaborations, and supported study proposals 

  • Takes the role of Lead Scientific Responsible and acts as a member of the SMT (study management team)  

  • As appropriate, provides medical expertise and scientific data to support Regulatory, Drug Safety, Health Economics/Market Access, Patient Partnership and Public Policy strategy and documents  

  • For established products, contributes to the comparative benefit-risk assessment and integrates the new benefit elements from clinical studies and other data sources in the overall benefit context

Medical Dissemination – Education, Scientific Congress Activities, Publications:

  • Contributes to the medical education needs assessments (internal & external)

  • Contributes to and/or leads the medical content of the medical education activities and publications, in collaboration with Scientific Communications

  • May present relevant data at congress events (e.g. affiliate briefings) and provide medical education to internal stakeholders (‘medical preparedness’)

  • Contributes to /reviews/ signs off medical education materials, (medical) Q&A and other documents for internal distribution and/or for external use

  • Provides guidance /contributes on how to translate complex scientific/medical information into lay terms (e.g. patient materials  etc.)

Promotional materials:

  • Accountable for accurate and balanced medical information 

  • Reviews and/or approves (sign off) of promotional materials, as appropriate  

Medical Insights - Advisory boards:

  • Leads and/or provides input to the advisory board plan for the assigned product(s)/DA

  • Responsible for the medical scientific robustness of the information presented and for advice seeking questions 

  • Responsible for aligning advisory board advice requests with all internal and external stakeholders, such as e.g product development partners, iSquad, lifecycle team and advisors

  • Leads and may present the medical/scientific aspects of assigned product(s) at the advisory board meetings

Cross-functional collaboration:

  • May serve as a member of global and international cross-functional teams and may lead the iMP (integrated Medical Partners Team)

  • May serve as a member of the integrated launch team and lead the medical aspects 

  • May represent PDMA (in cross-functional /integrated teams) across all stages of product journey/ life cycle, e.g. on iSquad, LCT, GDT, and/or other work-product teams, including early development stages with RED partners/teams, joint activities with DIA or other Roche Group entities


 

Career Path (depending on but not limited to experience, competency and seniority):

Career paths are similar for Specialist/Expert track or where People Leader and Coach determines major responsibilities.

Specialists/ Experts:

  • Associate GMD/GMSD: Entry level, and where medical expertise is required. No/ limited pharmaceutical experience needed. Participates mainly in execution of evidence generation strategy and plans, and/ or other areas of Medical Affairs responsibilities (e.g. Medical Insights and/or Medical Dissemination)

  • GMD/GMSD: Is able to work across all aspects of the job, typically under the guidance of a more senior/experienced GMD/GMSD or Medical Affairs Professional. Contributes to the understanding of access evidence needs and provides relevant input into integrated evidence generation plan. Contributes to the medical strategy components. Participates in various activities related to evidence generation, medical contributions to market access, medical dissemination, and external stakeholder collaborations, as appropriate.

  • Senior GMD/GMSD: May act as a product(s)/disease area expert and major strategic contributor. May represent PDMA on iSquad, GDT and/or LCT where required. Fully accountable for (medical affairs) evidence generation strategy, including pre-approval strategy and access evidence perspectives (in collaboration with Market Access). Anticipates the importance of new stakeholders and oversees stakeholder collaborations with regard to evidence generation strategy development and/or scientific collaborations. May serve as a Global Medical (team) Lead.

  • Principal GMD/GMSD: Major strategic (medical) contributor. Typically leads evidence generation strategy for product(s)/DA including complex molecules or indication(s).  Acts as major representative (ambassador) for the DA, both within PDMA and beyond. Is typically assigned to the most complex and strategically critical projects and/or evidence generation and/or scientific collaboration programs in the relevant DA. Drives innovation (incl. implementation of new methodologies, digital health solutions, personalization of medicine) and cross-functional collaborations 

People Leader and Coach

  • In line with experience, competencies and qualification applies ‘servant leadership’ and leverages the  ‘agile leadership framework’

  • Operates by coaching and enables (a network of) Medical Affairs Professionals to achieve results in a complex environment, in order to  serve patient and societal benefits.

  • Responsible for coaching, development and engagement of networks and/or teams

  • Communicates a compelling vision and engages people to deliver against function/Chapter North Star

Professional and Technical 

  • MD with relevant clinical research and/or medical practice experience (patient care decision-making) at the point of care (and/or where mandated by business needs and regulations) (GMD), or advanced life-science degree with comparable background and compatible with business setting (e.g. PhD /PharmD) (GMSD)

  • Specialization degree and experience in the disease area are a plus

  • Medical affairs and/or pharmaceutical medicine experience as well as people management experience/priority may inform level of seniority, and roles (specialist/expert and/or people leader and coach)


Technical and Behavioural Competencies:

  • High ethical standards

  • Ability to demonstrate an enterprise mindset, Roche Values, Pharma Operating Principles, Roche Leadership Framework, including Agile principles, ways of working and management

  • Ability to think about long-term evolution of healthcare ecosystems and appropriately evaluating strategic evidence planning

  • Strategic agility and decision making ability

  • Patient-centric approach to Clinical Development & Medical Practice

  • Functional competencies, including but not limited to organization, prioritization and planning skills, negotiation skills, communication & presentation skills

  • Ability to operate successfully in a (cross-functional) matrix environment with shared accountability and responsibilities

  • Ability to work with an open, collaborative and service-oriented mindset

  • Ability to build purposeful networks with Healthcare Stakeholders

  • Ability to work across multiple cultures and countries

Agile ways of working /Agile Leadership Framework:

  • Shows potential for, utilizes and/or models modern ways of working consistent with an agile mindset, behaviours, and methodologies (e.g. see: McKinsey - Agile Organizations)

  • Acquires, has appropriate knowledge of agile methodologies e.g. sprint, scrum, design thinking, lean

  • Encourages and coaches others to evolve their agile ways of working 

  • Ensure empowerment, co-creation; works cross-functionally & cross-geographies

  • Cultural and organizational agility, comfortable with operating and influencing without formal authority in a global network/matrix environment

  • Entrepreneurial mindset, and strong problem-solving capability focussed on outcomes/impact and team success

  • People management guided by servant leadership, feedback, coaching and mentoring principles, enabling self-organizing teams


 

Experience, Skills, Knowledge

  • Professional experience, in clinical research, medical practice and potentially within the pharmaceutical industry (preferably in medical function at global or regional/affiliate level) 

  • Strong knowledge of the overall drug development, life cycle process and experience in development and implementation of clinical trials, and or other methods of other data generation activities

  • Understanding of healthcare ecosystem maturity and value

  • Relevant clinical and scientific knowledge

  • Ability to leverage and integrate emerging trends in Digital Health and Technology as well as in Data Science

  • Previous experience with launch of medical product(s)/indications is a plus

  • Expertise with a wide range of data and information (e.g. scientific, clinical and regulatory)

  • Experience in the principles of data analysis, interpretation and assessing clinical relevance

  • Experience of partnership and collaboration with TAEs (and other stakeholders of the medical community) and external organizations

  • Business acumen: Good understanding of business context and model,  incl. access evidence requirements and external value/decision-making drivers

  • Fluency in written and spoken English

Please note that whilst we have a preference for the role to be located in the locations listed, we are flexible on where the successful candidate will be based and we welcome applications from candidates who are able to work across European time zones i.e. +/- 3 hrs CET.

Job Level:

Individual contributor