(Lead/Senior) Medical Director - Neurodegeneration

Job description

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The PositionGENERAL POSITION SUMMARY AND PURPOSE: Roche’s Clinical Development organization is structured by therapeutic area and is responsible for developing and executing the late development (Phase II – III) clinical strategies and plans that deliver medically-differentiated therapies that provide meaningful improvement to patients. The Lead Medical Director leads or makes major contributions to development of the Clinical Development (CD) strategy and plan and is responsible for effective and efficient execution for the assigned molecule(s)/indication(s). Lead Medical Directors are expected to perform their responsibilities with more independence by comparison to Medical Directors. 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 Significant 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 Significant pharma/biotech industry experience OR is a recognized expert in the field Significant experience designing and conducting clinical trials (i.e. one or more trials) Experience authoring a global development plan is preferred Understanding of Phase II – III drug development Knowledge and understanding of Phase I & IV drug development is a plus Understanding of product and safety profiles 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 required 4 or more years pharma/biotech industry experience OR is a recognized local expert in the field (e.g Assistant Professor or equivalent) 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 Is regarded as knowledgeable in his/her field, is respected by others, can effectively contribute to longer-range drug development, and can lead cross-functional teams to successful results Business Acumen: Has sound knowledge of the pharma/biotech industry, the multiple functions and roles involved in the drug development process. Organization: Can prioritize multiple tasks and goals on time, on target, and within budget Interpersonal skills: Strong interpersonal, verbal communication and influencing skills: can influence without authority and has proven experience building and cultivating relationships with key partners and stakeholders, both internally and externally Writing: Outstanding written communication skills Presentation skills: Strong business presentation skills: effective at summarizing and presenting the key considerations and decision-points.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: Strong negotiation skills: can effectively drive discussions and decisions toward desired end-results Decision Making: Makes good business decisions and exercises sound judgment. Balances decisions with imperatives for ethics and efficacy. Able to make trade-off decisions and determine priorities and goals Financial acumen: proven abilities for effective planning, development and oversight of project budgets and other resources Mentoring: Aptitude or proven ability to mentor colleagues and foster their successful career development SPECIFIC DUTIES AND RESPONSIBILITIES: CDP Strategy and Planning Leads or makes major contributions to development of the CD plan for assigned molecule(s)/indication(s) Gathers and analyzes data and information necessary to create the CD plan Responsible to ensure strategic and operational alignment of the CD plan with the relevant CD strategy, strategic and annual LCPs 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. Represents CD for the assigned molecule(s)/indication(s) to other internal Roche groups 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. May consult to pharma partnering on relevant acquisitions, joint ventures or other strategic partnerships, as these potentially relate to the assigned therapeutic/disease area(s) May provide clinical science input into annual and strategic Lifecycle Plans (LCPs) and the Integrated Development Commercialization Plan (IDCP) CDP Execution Leads 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 Plays a major role 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 Responsible to ensure investigators are appropriately and thoroughly briefed, in a timely manner, on medical/scientific matters relating to each study Responsible for 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 Acts as CD lead in development of study analytics and data management plans Leads 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 issu