Lead Medical Director, Product Development, Neuromuscular
The Position
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 or Required ; Board Certified Neurologist with Neuromuscular clinical experience 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 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
Four (4) or more years pharma / biotech industry experience OR is a recognized local expert in the field Assistant Professor or equivalent )
Up to 30% global travel
Key Skills and Behaviors
Ethics : Has impeccable ethics. Demonstrates, or proven ability to demonstrate, Roche Values
Attention to detail : Outstanding attention to detail
Is regarded as knowledgeable in one's field of expertise, 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 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 CD in sub-teams 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, proactively contributes to and promotes scientific discussion in the community and contributes to site-wide initiatives.
Contributes to discussions in the Global PDC community
Location : Boston, MA (USA), Basel (Switzerland) or Welwyn (UK). Relocation benefits are provided for this position.