Global Development Leader-group Medical Director

Vor 3 Tagen

Basel, Schweiz Genentech Vollzeit

THE POSITION

Roche’s Clinical Development organization is structured by therapeutic area and is responsible for developing and executing the late development (Phase II - IIIA) clinical strategies and plans that deliver medically-differentiated therapies that provide meaningful improvement to patients. The PD Group Medical Director would occupy the role of Global Development Leader who leads and who is responsible for developing global Clinical Development (CD) strategies/plans and ensuring effective and efficient CD plan execution for one or more molecules/indications. The PD Group Medical Director guides the development of and approves CD strategies, priorities, final interpretation, and completion of clinical study results. The PD Group Medical Director interacts with the highest levels of management and experts both internally and externally; serving as an internal consultant to Roche committees as well as representing the therapeutic area’s CD strategy, plans, objectives, and interests to health authorities (HAs) and prominent thought leaders. The PD Group Medical Director is expected to provide critical insights and contributions to the overall development and effectiveness of the assigned therapeutic area(s), including therapeutic area scientific strategies and plans.

Roche Product Development Neuroscience is recruiting an outstanding scientific leader in Neuroscience to serve in the Neurodevelopment franchise. In this role, the individual will function as the Global Development Leader for a new treatment for Angelman Syndrome. The role will be primarily based at Roche in Basel within the Clinical Development Group (with online work while COVID precautions remain in place); responsible for the design and execution of late phase clinical trials. There will be the opportunity for travel and direct interaction across Roche/Genentech. As a scientific leader on the team you will be responsible for:
Cross-Functional Team Leadership
- Typically, a standing member of the therapeutic area’s CD Leadership Team
- Leads one or more CSTs
- Represents CD for the assigned portfolio at the highest management/expert levels inside and outside Roche; includes championing and sponsoring the work of his/her staff

Staff Leadership & Development
- Works with manager and peers to identify and ensure the appropriate infrastructure - clear roles and responsibilities, learning and development, technology, other tools, vendor partners, and operating budgets
- Where applicable, may participate in the negotiation with and commissioning of external vendor partners to support certain elements of the therapeutic area’s CD function
- Assigns direct reports their projects and programs and guides direct reports in their assignment of projects and programs across their staff
- Cascades strategic and other relevant goals and objectives as well as expense budgets to direct reports
- Plays a leadership role in all formal and informal performance management and career development activities for his/her staff members

Global Clinical Development Planning
- 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). Ensures the same across his/her staff
- Provides CD leadership guidance and direction regarding competitive intelligence and/or another market/industry assessment activities and projects

Global Clinical Plan Development Implementation
- Accountable for the design, execution, and medical/scientific data interpretation of global clinical studies and programs across the assigned portfolio:

- Manages across multiple, often large-scale, and highly complex projects
- Provides guidance to direct reports in the strategy, design, and implementation of clinical studies and other programs
- Keeps partners and stakeholders abreast of developments relative to the work of CD and the assigned portfolio and ensures they same approach is consistently taken across his/her staff

QUALIFICATIONS & EXPERIENCE:

- 4 or more years of experience managing medical/clinical staff
- 6 or more years of experience with clinical trials and 2 or more years of experience submitting NDAs/BLAs to regulatory authorities in Europe and/or the U.S.
- 3 or more years of experience authoring global clinical development plans and publishing results of clinical drug trials in referred journals
- In-depth understanding of Phase I - IV drug development Multidisciplinary experience in the pharma/biotech industry is strongly preferred (e.g., research, regulatory, clinical operations, business development, commercial operations, etc.)
- Strong academic/teaching background is strongly preferred

DEMONSTRATED COMPETENCE IN THE FOLLOWING AREAS:

- Collaborative leadership for making decisions encouraging others to work together, and fostering creativity and in

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