R&d Project Leader Serious Bacterial Infections

vor 2 Wochen

Genf, Genf, Schweiz Global Antibiotic R&D Partnership (GARDP) Vollzeit

Overall Purpose
The R&D Project Leader is responsible for professional execution of assigned drug/treatment development projects to time, quality, and cost.

This individual leads a multi-disciplinary team(s) for late-stage development projects with responsibility for planning, steering and coordination of all nonclinical development, pharmaceutical development activities that support the core clinical development from end of first time in man through to launch.

The Project Leader is also responsible for overseeing initial access development related to the drug/treatment aligned with a disease area strategy.

The role may also include responsibility for nonclinical and clinical aspects in the development of new indications, combinations, and formulations, including also those required to develop paediatric indications.

The level of leadership and accountability related to these activities will depend on GARDP's role as agreed in the particular partnerships.


The R&D Project Leader will be accountable for delivering either a drug product to regulatory approval and/or the evidence to support final use of the drug as a treatment for patients with serious bacterial infections caused by priority pathogens in those populations particularly impacted by antibiotic resistance.

Also, they will be responsible for developing an initial access plan including market access elements for future transition.


This R&D Project Leader will be responsible for (a) key development project(s) within the Serious Bacterial Infections and Children's Antibiotic programmes under the Sepsis Disease Area Strategy.


Contribution


He/she/they turns the strategic intent into operational reality through the design, development, and implementation of projects to meet the disease area and organization mission.

He/she/they plans, integrates, and coordinates work to deliver a comprehensive project(s) and leads cross functional operational aspects of the delivery.

He/she/they proposes strategic direction, staffing and budget decisions to his/her/their direct supervisor related to the project. He/she/they develops new approaches, technics or policies and establish important guidelines.


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


Scope of Work

_Drug/treatment development _

  • Ensures the projects and studies follow best practice and regulatory compliance including international GCP, SOPs, and other relevant regulations, and keep and organize appropriate documentation to that end.
  • Maintains an uptodate knowledge of global drug development regulations, good clinical practice guidelines (i.e., GCP, ICH) and compliance issues (e.g., PhRMA guidelines).
  • Accountable for all projectrelated clinical development documentation with support from study team, Medical, clinical operations, pharmacovigilance, and QA.
  • 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.
  • Leads preparation of key regulatory interactions such as Pre-IND, EndofPhase II, Pre-NDA, formal response meetings, etc.
  • Facilitates interpretation and assessment of clinical trial data and confirms decision making with key input from Medical and other key team members. Together with Medical produces benefitrisk evaluations to steer drug development activities and development paths.

_Access development and disease area alignment_

  • Align drug development and post approval activities with access development strategies led by Medical and coordinated with the Access Lead.
  • With expert input from Disease Area Medical Lead
  • Ensures alignment with the disease areas strategy to ensure target product profile is appropriate from a clinical and scientific perspective including analysis of optimal position and use as a treatment.
  • Develop and maintain an uptodate knowledge base for assigned project(s).
  • Oversee the development of the initial access plan including the market access elements as part of accountability for the overall drug/treatment development plan.

Reporting line

  • He/she/they reports to the Serious Bacterial Infection Program Lead
  • Works across all GARDP departments including BD, Global Access, Finance, External Affairs, Legal and also with our partners including in particular CMC, translational science in DNDi.
  • Maintains frequent interaction with key external experts driving or supporting the project, including GARD's Scientific Advisory Committee members, and various partners/vendors teams involved in the project.
  • He/she/they 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/they repre

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