Medical Lead

**Overall Purpose**:
The Medical Lead will deliver the medical strategies and lead execution of plans for the clinical development and delivery of new and existing antibiotics as treatments for priority drug resistant infections aligned with a GARDP disease area strategy.

He/she will be the medical lead for an R&D drug project led by an overall project lead and will be overall responsible physician for the clinical studies and activities within the project. He/she will develop a disease area strategy to inform development and access provisions for treatments within said disease area. They will develop medical and public access strategies at the level of the antibiotic in development and for a broader disease area approach for GARDP and related access partnerships.

**Contribution**

He/she turns the strategic intent into operational reality through the design, development and implementation of program/projects or the provision of services to the entire organization. He/she plans, integrates, and coordinates work to deliver a comprehensive program or a service platform and manage operational aspects of the delivery. He/she develops new approaches, technics or policies and establish important guidelines. He/she proposes strategic direction, staffing and budget decisions to his/her direct supervisor.

**Scope of Work (Results)**

His/her role affects delivery of a program/projects and success of the team and directly impact on the output of GARDP in the short to medium terms (cf. project cycle). Or it affects delivery of the service and influence the effectiveness of GARDP operations. Information disseminated to external communities affects the image of GARDP, impacting on the commitment of stakeholders and resource mobilization.

**Tasks and Responsibilities**:

- **Clinical Development**
- Medical lead for late stage studies in the sepsis portfolio, including support for the children’s antibiotics project
- Medical oversight of Clinical pharmacology and other observational studies supported by study physician
- Support for study physician overseeing Access development studies as needed.
- Regulatory strategy development and Submission support along with Head of Regulatory function
- Assist PV lead in safety surveillance and development of safety related documents.
- Support for Clinical project regulatory workstreams
- Support related to non-clinical activities (microbiology, PK, etc.)
- Co-lead/lead the clinical project team
- **Access development**
- With R&D Access development Lead and Market access individuals provide the medical leadership to plan and execute access strategies and activities including regulatory pathways, post approval evidence generation and public health access pathways
- **Disease area strategies**
- Assist inevelopment of Sepsis programme level disease area strategies to guide both clinical and access development at the project level.
- Develop the medical and public health strategy and regional plans to guide the access solutions for the sepsis portfolio with partners engaged in access initiatives.

**Tasks and Responsibilities for Sepsis project staff**
- Including direct & matrix leadership of medical, clinical science and clinical operations staff, study, clinical project, and cross functional program teams where appropriate

**Reporting line**

He/she will report into the GARDP Medical Director and will be part of a cross functional drug /treatment project team

**Interactions**

Works with disease area and project level colleagues in matrixed leadership teams.

He/she has frequent interaction with GARDP staff and external stakeholders to coordinate provision of work or to advocate, persuade and gain support or commitment. He/she represents GARDP for a program/service area and develop and maintain relationship with current and future partners.

**Requirements**:
**Skills and Attributes**
- High ability to use initiative, prioritize, multi-task, and work well under pressure to meet deadlines
- Very clear and systematic thinking that demonstrates strong judgment and problem solving competencies
- Excellent communication, and public speaking skills, ability to convince and represent GARDP at high level events
- Knowledge of managing global multicultural teams
- Highly organized and structured
- High analytical skills
- High ability to lead large strategic projects
- High ability to manage large size projects with budget management
- Very strong strategic thinking and leadership abilities
- Excellent management, negotiation, and advocacy skills
- High ability to exercise high degree of independence to ensure program delivery and explore new areas of activities
- High ability to interact with internal and external stakeholders
- High ability to lead and motivate a team for optimum performance

**R& D Technical Skills - **GARDP Leadership Competencies
- Orientation to developing others
- Strategic expertise
- Professional competence
- Care of relationships
- Leading by example
- C