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The Position
GENERAL POSITION SUMMARY AND PURPOSE:
The Roche Clinical Development organization is structured by therapeutic area and is responsible for developing and executing the late stage development (Phase 2-3) clinical strategies and plans to deliver medically differentiated therapies that provide meaningful improvement to patients.
The Medical Director participates in development of the Clinical Development (CD) strategy and plan and helps ensure effective and efficient execution for the assigned molecule(s)/indication(s).
The Medical Director is an entry-level PD Clinical Director position and, as such, Medical Directors are developing their knowledge of clinical studies and the pharma/biotech industry.
EXPERIENCE AND QUALIFICATIONS:
- Academic/Scientific/Clinical:
- M.D. Required
- Relevant clinical, scientific, or clinical trial/development experience in same/similar therapeutic area required
- Academic/teaching background is a plus
- Experience working with the principles and techniques of data analysis, interpretation, and clinical relevance
- Experience publishing results of a scientific study in a peer-reviewed journal is preferred
- Regulatory: Knowledge of medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMA, and other relevant guidelines and regulations is preferred
- Duration of Experience: 2 or more years of post-graduate academic or clinical experience
- Up to 30% global travel
Key Skills and Behaviours
- Ethics: Has impeccable ethics. Demonstrates, or proven ability to demonstrate, Roche Values
- Attention to detail: Outstanding attention to detail
- Business Acumen: Has working knowledge of the pharma/biotech industry, the multiple functions and roles involved in the drug development process. Regularly leads development of disease strategies and plans
- Organization: Can prioritize multiple tasks and goals on time, on target, and within budget
- Interpersonal skills: Good interpersonal, verbal communication and influencing skills: can influence without authority
- Writing: Strong written communication skills
- Presentation skills: Good business presentation skills; is comfortable and effective when presenting to others, internally or externally.Confident and competent when interacting with others internally and externally: stays focused and on-point, is able to raise problems or challenges in a productive and mature manner
- Negotiation Skills: Good negotiation skills: knows how to complete deliverables by working effectively with others internally and externally
- Decision Making: Knows how to make trade-off decisions while balancing ethics and efficacy
- Teamwork: Strong orientation to teamwork
SPECIFIC DUTIES AND RESPONSIBILITIES:
CDP Strategy and Planning
- Participates in development of the CD plan for assigned molecule(s)/indication(s)
- Gathers and analyzes data and information necessary to create the CD plan
- Works with other CST members and relevant sub-teams to develop CD plan components (e.g., analytics/data strategy, KOL development, publications strategy, etc.)
- Works with CST and other relevant teams to develop and provide information and input for budget/resource requirements necessary to implement and execute the CD plan
- Stays abreast of internal and external developments, trends and other dynamics relevant to the work of CD to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for the assigned therapeutic and disease area(s)
- As appropriate, participates in competitive intelligence and/or other market/industry assessment activities and projects
- Maintains the highest standards and levels of scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment
- Collaborates with a variety of internal and external partners and stakeholders, such as clinical investigators, clinicians, scientists and key opinion leaders (KOLs), as well as multidisciplinary internal groups, including other groups in PD, research, business development, commercial operations, legal, etc.
- May participate in meetings, reviews, discussions and other interactions regarding early development/Phase I studies to provide clinical science input and guidance. Includes reviewing and providing late stage input into Phase I and II protocols
- Supports internal partners in transitioning new drugs/indications into Medical Affairs (MA) studies, including providing CD input for MA study protocol development.
CDP Execution
- Participates in design, development, and execution of clinical studies
- Collaborates with others in the development of product safety profiles, clinical sections of investigator brochures, presentations and other materials
- May guide and advise others in the identification and selection of appropriate external investigators and sites
- Participates in the development and implementation of communications strategies to support ongoing and concluded studies. Includes investigator meetings and KOL interactions, advisory boards, major medical meetings, congresses and other events, publications and other materials
- Participates in development and delivery of key presentations, both internally and externally, to convey the CD perspective and provide updates on strategies, plans and other activities. Includes presenting at advisory boards and other relevant external forums representing Roche
- Collaborates with others in development of study analytics and data management plans
- Participates in ongoing reviews of medical/safety data
- Collaborates with relevant team members to measure and monitor study progress against objectives and plans, including any variances, and proactively communicate any issues, challenges and potential strategies to resolve such
- Collaborates with relevant team members to ensure timely, completion of interim study reporting
- Collaborates with relevant team members and clinical operations to close-out clinical studies, secure data and complete study reporting
- Supports other CST members to ensure correct medical/scientific data interpretation for interim and final study reporting
- Acts as a medical monitor for assigned studies
Cross-Functional Team Leadership
- Participates in the relevant Clinical Science Team (CST)
- Participates as standing or ad hoc member of sub-teams (e.g. Study Management Teams) relevant to assigned molecule(s)/indication(s) and supports cross-functional integration, coordination and alignment to enable effective and efficient CD plan execution
- Supports training of new CST members
- May also, as appropriate, support relevant sub-teams in assigning and training new team members
Regulatory Activities
- Supports other CST members in development of briefing packages by providing clinical science information and input
- Supports other CST members in development of responses to HA questions by providing clinical science information and input
- Participates in health authority (HA) interactions, as appropriate, with supervision from more experienced Medical Directors
- Supports other CST members, regulatory and other internal partners/stakeholders in the completion and submission of regulatory filings and other regulatory documentation. Provides clinical science information and input for regulatory submissions and other regulatory processes. Includes developing label and packaging language, etc.
Local/Global Communities
- Visible in the local site community, e.g. contributes to scientific discussion in the community. Able to provide study/program updates to the wider community
Who we are
A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.
Roche is an Equal Opportunity Employer.