Objectives and Scope of Position:
GMDis the PDMA strategic lead for a product as of the Life Cycle Investment Point or, where appropriate, prior to this, during Integrated Development and Commercialization Planning process
GMD drives the medical strategy development for the assigned product(s) and alignment with brand strategies. Contributes to the medical strategy development for the disease area (DA)
Provides strategic guidance to the International Medical Directors (IMDs), International Scientific Directors (ISDs) and other members of the cross-functional global medical team (IMP)in the medical strategy development
The role requires strong leadership skills, scientific expertise and clear business understanding to identify and address the relevant medical needs of clinical practice and lead high- performing cross-functional team(s)
Summary of Main Responsibilities:
Strategic Medical Leader:
Builds a deep understanding of the current and future direction of the DA and product(s)
Typicallyensures cross-functional collaboration to drive the medical strategy development, accountable for the medical strategy alignment with the overall brands strategies
Accountable that strategic medical input is provided into the Lifecycle Plans, Brand Plans, relevant launch plans, Comparative Benefit Risk Assessment and other related documents
Accountable for the benefit risk assessment of the product(s) in relation to Medical Affairs evidence generation activities
Assesses the need and coordinates compassionate use of the assigned product(s)
Identifies potential medical interest for line extensions, considering the scientific rationale and the understanding of current and anticipated future medical practice
Ensures that medical/scientific data are provided to other stakeholders, e.g. Regulatory, Drug Safety, Health Economics, Public Policy as appropriate
Contributes to implementing appropriate policies/standards for all activities of the medical plan
People Leadership:
Typically leads product medical strategyoverseeing the activities of the team
Drives and models cross-functional collaboration and communication with other stakeholders and functions, within and outside PDMA
Evidence Generation Strategy:
Drives the strategy of the integrated evidence generation, incl. clinical studies, Investigator Initiated Studies (IIS), RWD, Roche sponsored indirect comparisons
Patient Access:
Ensures that integrated evidence generation strategy is developed on good understanding of access needs and value decision drivers
Encourages and drives cross-functional collaboration with PD and GPS functions and with iSQUADS to understand the needs and value/decision drivers of broad set of stakeholders relevant for patient access. Ensures that these insights are translated into an effective medical strategy
Provides medical expertise and input into the market access, brand and lifecycle strategies. Provides medical expertise to the IPST and other teams (e.g. launch teams) or guides IMDs in their respective responsibility
Maintains a broad overview of access evidence requirements and external value/decision drivers relevant for the assigned product(s)/DA
External Collaborations:
Develops, advances and maintains TAE collaborations
Represents Roche in peer-to-peer interactions with external collaboration partners
Decisions making authority and budget:
HR decisions on team members/line reports
Budget decisions
Compliance:
Responsible for acting in line with legal, regulatory and company standards and codes of practice
Completes all required training modules as a priority, and is responsible for the team members to act similarly
Summary of Extended Responsibilities
Execution of Evidence Generation Activities:
Accountable for evidence generation activities for the product(s)/DA, including risk benefit assessment and patient safety in all PDMA interventional studies
Ensures that review and approval of IIS, supported study proposals and affiliate study synopses is conducted according to the standards and within timelines
Ensures sign-off on study concepts, synopsis and protocols of PDMA studies to PAC
For established products, ensures that comparative benefit-risk assessment is conducted and the new benefit elements generated in the clinical studies and all other data sources are integrated in the overall benefit context
Medical Education and Congress Activities:
Ensures that brand and medical expertise is provided to medical education events, and, where needed, presents data at congress events
Accountable for the content development for internal medical trainings and/or may delegate this to other GMT members, as appropriate
Advisory boards:
Provides input on the advisory board plan for the assigned product(s)/indication
Accountable for the medical scientific robustness of the information presented and for advice seeking questions and/or delegates this to the appropriate team member
lead and/or present the medical aspects of assigned product(s)
Cross-functional collaboration:
Lead Medical Launch team
May represent PDMA in LCT and GDT across all stages of life cycle, including early development
Job levels:
GMD typically leads IMP and/or Medical Launch team and is accountable for all aspects of medical strategy development and implementation. Drives cross-functional collaboration with other PD and GPS functions for integrated evidence planning, and typically represents PDMA in LCT and GDT.
Professional and Technical Requirements
MD/PhD or comparable, with relevant clinical experience (patient care decision making) at the point of care, board certification and disease area knowledge are a plus
Competencies:
Experience, Skills, Knowledge