Lead Medical Director - Neurodegeneration

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 Position

GENERAL 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 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

• Responsible to ensure correct medical/scientific data interpretation for interim and final study reporting

• Works with other CST members in ongoing data generation to address unmet medical needs and identify new or extended CD studies for the assigned program 

• Acts as a medical monitor for assigned studies or delegates this responsibility appropriately

Cross-Functional Team Leadership

• Participates in and/or leads the relevant Clinical Science Team (CST) 

• Represents Clinical Development (CD) in sub-teams (e.g. Study Management Teams) relevant to assigned  molecule(s)/indication(s) and helps ensure cross-functional integration, coordination and alignment to enable  effective and efficient CD plan execution  

• Accountable for training new CST members 

• May also, as appropriate, support relevant sub-teams in assigning and training new team members

• Participates in ongoing enhancements/development of core and sub-team processes, structures, systems, tools and other resources 

• When assigned/appointed, acts as the Clinical Science Lead (CSL).

Regulatory Activities

• Takes an active role in development of briefing packages by providing clinical science information and input 

• Takes an active role in development of responses to HA questions by providing clinical science information and input 

• Takes an active role in health authority (HA) interactions with little to no supervision from more experienced Medical Directors

• Takes an active role with 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. proactively contributes to and promotes scientific discussion in the community and contributes to site-wide initiatives. Contributes to discussions in the Global PDC 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.