Lead Medical Director, Product Development, Neuromuscular

TN United Kingdom; Plymouth; On-site; GBP 80,000 - 120,000; Full time

Job description

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Lead Medical Director, Product Development, Neuromuscular, Welwyn

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EU work permit required:

Yes

Job Reference:

02bfc694f712

Job Views:

9

Posted:

24.04.2025

Expiry Date:

08.06.2025

Job Description:

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 Required:

1. Board Certified Neurologist with Neuromuscular clinical experience required
2. Relevant clinical, scientific, or clinical trial/development experience in same/similar therapeutic area required
3. Academic/teaching background is a plus
4. Significant experience working with the principles and techniques of data analysis, interpretation, and clinical relevance
5. Experience publishing results of a scientific study in a peer-reviewed journal is preferred
6. Significant pharma/biotech industry experience OR is a recognized expert in the field
7. Significant experience designing and conducting clinical trials (one or more trials)
8. Experience authoring a global development plan is preferred
9. Understanding of Phase II – III drug development
10. Knowledge and understanding of Phase I & IV drug development is a plus
11. Understanding of product and safety profiles
12. 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
13. Four (4) or more years pharma/biotech industry experience OR is a recognized local expert in the field
14. Up to 30% global travel

Key Skills and Behaviors:

1. Ethics: Has impeccable ethics. Demonstrates, or proven ability to demonstrate, Roche Values
2. Attention to detail: Outstanding attention to detail
3. Business Acumen: Has sound knowledge of the pharma/biotech industry, the multiple functions and roles involved in the drug development process.
4. Organization: Can prioritize multiple tasks and goals on time, on target, and within budget
5. Interpersonal skills: Strong interpersonal, verbal communication and influencing skills
6. Presentation skills: Strong business presentation skills
7. Negotiation Skills: Strong negotiation skills
8. Decision Making: Makes good business decisions and exercises sound judgment
9. Financial acumen: Proven abilities for effective planning, development and oversight of project budgets and other resources
10. Mentoring: Aptitude or proven ability to mentor colleagues and foster their successful career development

Specific Duties and Responsibilities:

1. CDP Strategy and Planning
2. Leads or makes major contributions to development of the CD plan for assigned molecule(s)/indication(s)
3. Gathers and analyzes data and information necessary to create the CD plan
4. Responsible to ensure strategic and operational alignment of the CD plan with the relevant CD strategy, strategic and annual LCPs
5. Works with other CST members and relevant sub-teams to develop CD plan components analytics/data strategy, KOL development, publications strategy, etc.
6. 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
7. Maintains the highest standards of scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment
8. Collaborates with a variety of internal and external partners and stakeholders
9. Represents CD for the assigned molecule(s)/indication(s) to other internal Roche groups
10. May participate in meetings, reviews, discussions and other interactions regarding early development/Phase I studies
11. Supports internal partners in transitioning new drugs/indications into Medical Affairs (MA) studies
12. May consult to pharma partnering on relevant acquisitions, joint ventures or other strategic partnerships
13. May provide clinical science input into annual and strategic Lifecycle Plans (LCPs) and the Integrated Development Commercialization Plan (IDCP)
14. CDP Execution
15. Leads design, development, and execution of clinical studies
16. Collaborates with others in the development of product safety profiles, clinical sections of investigator brochures, presentations and other materials
17. Responsible to ensure investigators are appropriately and thoroughly briefed, in a timely manner, on medical/scientific matters relating to each study
18. Acts as CD lead in development of study analytics and data management plans
19. Collaborates with relevant team members to measure and monitor study progress against objectives and plans
20. Collaborates with relevant team members to ensure timely completion of interim study reporting
21. Responsible to ensure correct medical/scientific data interpretation for interim and final study reporting
22. Acts as a medical monitor for assigned studies or delegates this responsibility appropriately
23. Cross-Functional Team Leadership
24. Participates in and/or leads the relevant Clinical Science Team (CST)
25. Represents CD in sub-teams relevant to assigned molecule(s)/indication(s)
26. Accountable for training new CST members
27. Participates in ongoing enhancements/development of core and sub-team processes, structures, systems, tools and other resources
28. Regulatory Activities
29. Takes an active role in development of briefing packages by providing clinical science information and input
30. Takes an active role in development of responses to HA questions by providing clinical science information and input
31. 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
32. Local/Global Communities
33. Visible in the local site community, proactively contributes to and promotes scientific discussion in the community

Location: Boston, MA (USA), Basel (Switzerland) or Welwyn (UK). Relocation benefits are provided for this position.