Project Leader - Serious Bacterial Infections (SBI) (UK, Spain, CH or EU)

GARDP is a not-for-profit organization focused on developing and delivering new or improved antibiotic treatments, ensuring sustainable access globally. Aligned with the Global Action Plan on Antimicrobial Resistance, GARDP collaborates with public and private sectors to encourage research and development of new antibiotic treatments.

Job Purpose: TheR&D Drug/Treatment Project Leader is a key project leadership role within the GARDP R&D team and across the SBI portfolio and organisation. Reporting to the R&D Director, this position leads the development of antibiotic candidates as treatments for SBIs including as a core component of co-development and licensing agreements with biotech/pharma and public partners. Strong leadership of cross functional and collaborative project teams is critical to delivering key objectives.

Key Areas of Responsibilities:

The Project Leader will be involved in the leadership of projects throughout the development process, with particular focus on the clinical development, CMC, nonclinical and access development strategies.

Drug/treatment development

·       Understands regulatory requirements for antibiotic development, nonclinical, clinical and CMC activities, documentation and processes for major regulatory agencies with a view to the eventual registration of the new treatment.

·       Ensures the projects and studies follow best practice and regulatory compliance including international GCP, SOPs, and other relevant regulations, and ensure appropriate project management, planning and control .

·       Facilitates interpretation and assessment of development data and confirms decision making with key input from Medical, pharmaceutical development and other key team members. Produces benefit-risk evaluations to steer drug development activities and development paths.

Access development and disease area alignment

·       Define evidence generation approaches required to transition a drug candidate into a treatment able to address the identified unmet need outlined in the target product profile.

·       Align clinical and pharmaceutical drug development activities with access development strategies.

·       Oversee the development of the initial access plan including the market access elements as part of accountability for the overall drug/treatment development plan

Contribution: TheR&D Drug/Treatment Project Leader turns the strategic intent into operational reality through the design, development, and implementation of projects to meet the portfolio and disease area strategy. They plan, integrate and coordinate work to deliver a comprehensive project(s) and leads cross functional strategic and operational aspects of the delivery. They propose strategic direction, technical and operational resource decisions for governance review. They develop new approaches, techniques or policies and establish important guidelines.

Qualifications and Attributes: The ideal candidate should have substantial experience in drug development (preferably antimicrobials) with a proven track record in leading cross functional project teams and/or collaborations. Technical background can from any key cross functional discipline but what is important is to facilitate expertise, provider sound judgment and take the lead on decision making where required. An international focus is critical and the ability to work and lead in partnership with private and public sectors is important.

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