IMD Ophthalmology (M / F / X)
Objectives and Scope of Position :
IMD is the core PDMA role responsible for the development and execution of evidence generation strategy for the assigned product(s) / disease area (DA) based on key insights and perspectives from multiple stakeholders (HCPs, patients, nurses and payers)
IMD provides medical / clinical expertise and input into the development of market access, brand and lifecycle strategies for the product(s) / DA
Accountable and responsible for the benefit risk assessment of the assigned product(s) in relation to Medical Affairs evidence generation and activities
Stays abreast of internal and external developments, trends and other dynamics relevant for the assigned DA to maintain a fully current view and perspectives of external influences
Summary of Main Responsibilities
Medical Strategy :
Accountable for the evidence generation strategy planning and execution, incl. (but not limited to) identifying medical and access gaps and needs as part of the overall medical strategy
Evidence Generation Strategy :
Drives and leads the strategy of the integrated evidence generation activities, incl. clinical studies, Investigator Initiated Studies (IIS), RWD and others
Accountable for the oversight of all clinical trials within medical affairs for assigned product(s) / DA, including affiliate clinical trials
Identifies potential medical interests for line extensions according to scientific rationale and good understanding of the actual and anticipated future directions of medical practice
Assesses the needs and coordinates compassionate use of the assigned product(s)
Patient Access :
In collaboration with iSquad, identifies the evidence generation needs / gaps in order to obtain and maintain patient access and integrates them into the evidence generation strategy
Provides medical expertise and input into the market access, brand and lifecycle strategies and plans (e.g. Life Cycle Plans, Integrated Evidence Plan, Brand Plans, Launch Plans, Comparative Benefit Risk Assessments and other relevant documents)
Represents PDMA and provides medical expertise to other relevant teams
External Collaborations :
Develops, advances and maintains TAE interactions and collaborations, incl. those aimed to set up and conduct evidence generation activities
Represents Roche in peer-to-peer interactions with external collaboration partners, including in patient-company interactions
Summary of Extended Responsibilities
Execution of Evidence Generation Activities :
Accountable for evidence generation activities for a product / DA, including risk benefit assessment and medical monitoring in all medical affairs interventional studies
Conducts review and approval of investigator initiated studies (IIS) and supported study proposals
Reviews affiliate study synopses and signs off affiliate studies
Signs off on study concepts, synopsis and protocols of PDMA studies
Takes the role of Lead Scientific Responsible and acts as a member of the SMT
As appropriate, provides medical expertise and scientific data to support Regulatory, Drug Safety, Health Economics 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 Education and Congress Activities :
Contributes to the medical education needs assessments
Accountable for the medical content of the medical education activities and publications (applicable for Senior / Principal IMD) in collaboration with the SCD / SCL
May present relevant data at congress events (e.g. affiliate briefings) and provide medical education to internal stakeholders
Signs off medical education materials, Q&A and other documents for internal distribution and / or for external use (applicable for Senior / Principal IMD)
Provides guidance to other GMT members 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 approves (sign off) promotional materials (applicable for Senior / Principal IMD)
Advisory boards :
Provides input on 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 iSquad, LCT and advisors, in collaboration with the ISD or SCD
Leads and may present the medical / scientific aspects of assigned product(s) at the advisory board meetings
Responsible for the budget oversight of the respective area and activities in close collaboration with the GIMD and the Project Manager
Responsible for acting in line with legal, regulatory and company standards and codes of practice
Completes all required training modules as priority
Cross-functional collaboration :
Acts as an medical iCommunity member, and if called upon, iMP, iSquad, LCT or other team member
Acts as a member and / or may lead the Medical Launch Team
May represent iMP in LCT and GDT across all stages of life cycle, including early development (applicable for Senior / Principal IMD)
Job levels :
Senior IMD : Is able to work independently. May act as a brand / disease area expert. When appointed and appropriate, may represent PDMA in LCT and iSquad.
Fully accountable for evidence generation strategy, including access evidence plan. Anticipates the importance of new stakeholders and oversees stakeholder collaborations with regard to evidence generation strategy development
Principal IMD : Typically leads evidence generation strategy for a complex molecule or indication. Acts as an ambassador for the Franchise, both within PDMA and beyond.
Is typically assigned to the most complex and strategically critical projects and / or evidence generation programs in the relevant DA.
Drives innovation (incl. implementation of new methodologies, digital care solutions) and cross-functional collaborations
Professional and Technical Requirements
Ophthalmologist MD with at least 5 years relevant clinical experience (patient care decision-making) at the point of care, incl.
retina care and surgical experience.
Technical Competencies :
High ethical standards Ability to demonstrate Roche Values and Leadership Commitments Strategic agility and decision-making ability.
Functional competencies, including but not limited to organization, prioritization and planning skills, negotiation skills, communication & presentation skills Ability to operate successfully in a matrix environment with shared accountability and responsibilities Demonstrated ability to work across multiple cultures and countries
Experience, Skills, Knowledge
Professional experience, both in clinical practice and within the pharmaceutical industry, in medical function at global, regional and affiliate level Strong knowledge of the overall drug development process and experience in development and implementation of clinical trials (Phase 3 and 4) Relevant clinical and scientific knowledge Previous leadership experience, e.
g. with launch of drugs / indications is a plus Proven 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 with TAEs and external organizations is strongly preferred Good understanding of business context, incl.
access evidence requirements and external value / decision-making drivers is preferred Fluency in written and spoken English, Spanish is a plus
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focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Roche is an equal opportunity employer.