Associate Director SBI Portfolio (Geneva or other locations) in Genf

GARDP Foundation is a not-for-profit global health organization driven to protect people from the rise and spread of drug-resistant infections, one of the biggest threats to us all.

By forging public and private partnerships that matter, we develop and make accessible antibiotic treatments for people who need them.

The Associate Director SBI Portfolio is a key programme leadership position across the GARDP organization.

This individual is responsible for the development and coordination of a portfolio of projects focused on the development and delivery of new and existing antibiotics as treatments for priority drug resistant infections aligned with the SBI disease area strategy (DAS).

This position provides strategic expertise and insight into an SBI portfolio strategy and the programme and projects within the portfolio.

The Associate Director operates as the cross functional Head of the SBI Portfolio with overall accountability for the strategy and execution of the multi-disciplinary R&D projects and ensuring the full alignment of the SBI access projects with the SBI programme and DAS strategies.

This individual leads a programme of projects and activities including multi-disciplinary team(s) led by project leads for regulatory development and strategic public health projects with accountability for planning, coordination and oversight of all nonclinical development, clinical development, pharmaceutical and access development activities from defining development plans through to execution and delivery at a programme level.

This role is also responsible for ensuring access activities related specifically to product availability are aligned with overall portfolio and disease area strategies.

The Associate Director SBI Portfolio as the programme lead will partner with the Head of Medical, SBI (or a Senior Medical Lead), if the the programme lead is not medically qualified, who will develop the medical scientific strategies at a Disease Area and programme level and support translation to activities for the clinical and access development projects..

Also he/she will coordinate with the Global Access Director to ensure and support an agreed aligned access strategy at the programme level.

The Associate Director SBI portfolio will be responsible with the Directors of Business Development and Partnerships Engagement and Global Access to ensure appropriate transition of project to commercial led status both within GARDP and with our sub-license partners.

This role will be the SBI portfolio representative across GARDP supporting external affairs and policy and advocacy activities

Key Areas of Responsibilities

• Develop and maintain a transversal SBI Disease Area strategy and support the translation to an SBI portfolio of programmes, projects and activities across R&D and Access including transition to a commercial model status..
• Lead the development and maintenance of respective disease area and programme strategies with the Medical Head/Lead SBI and Global Access Director to guide both drug and access development and implementation in alignment with GARDP’s mission and objectives.
• Define approach to strategic coordination and strategic decision making at the overall One SBI portfolio level
• Lead the cross functional evaluation of new interventions, potential assets and new project concepts for the SBI portfolio.
• Provide SBI portfolio leadership across GARDP supporting GARDP policy and advocacy, external affairs, communications activities
• With the Medical Head communicate and integrate the SBI disease area strategy internally within GARDP and externally with key stakeholders, partners and networks.
• Support the development of an external SBI advocacy plan with Head of Medical SBI, Global Access Director, External affairs and Executive office.
• Agree and implement with respective directors, at a project by project basis, transition points for projects from development led to either access and/or commercial model led.
• SBI Programme and Project Leadership
• Develop drug development and access development (with Global Access)strategies at the programme level for implementation in specific clinical and access led projects.
• Responsible with the Head of Medical for agreeing a scientific strategic direction and oversight of the projects within a programme.
• Ensure pharmaceutical development to final drug product manufacture strategies are developed and implemented to meet both regulatory and GARDP access objectives.
• Support cross-over and synergy across projects where appropriate.
• Provide a framework for project leaders for successful project planning and execution while providing clarity on level of decision making and accountability for project and programme governance.
• Line manage a team of R&D project leaders to design and execute drug/treatment development projects and oversight of Access-Led projects to support objectives agreed with the Global Access Director
• Ensure the appropriate input from R&D to Access Led SBI projects and review access led project strategies and plans to ensure an integrated access to development model and alignment with agreed SBI disease area and portfolio/programme strategy.
• Set up and oversee all programme and project leadership, management and reporting systems with the respective project leader, project managers and Head of Portfolio Management.
• Accountable for overall programme and specific project governance requests and reviews with GARDP Monthly Performance Review (GMPR) and directly with R&D Director
• Oversee the programme related preparations and interactions with the Scientific advisory committee (SAC) and ensure project team regular interactions with assigned SAC members
• Works with Head of Portfolio Management and finance to forecast, develop and monitor portfolio level budgets, resource estimations and allocation.
• Co-Lead partnership strategy with Business Development and Partnership Director and partner engagement at programme level.
• Provide collaborative and/or oversight role for GARDP in project level collaborations and the level of steering committee for joint development partnerships.
• Integrated development to access model alignment
• Work with key colleagues to ensure that access development objectives are integrated in all R&D Led project plans with key review and input by Head of Medical SBI for patient relevant activities and studies and by Global Access Director overall
• Review plans and progress of Access-Led projects with the Head of Medical SBI to ensure strategic alignment and progress and appropriateness of clinical and scientific workstreams
• Commit to communications supported by indirect reporting frameworkwith Global Access Director and Access Project Leaders
• Support the input from project leaders to the develop the commercial strategy and model led by Business Development and Partnerships and integrate into project plans including identifying appropriate transition points.
• Regulatory adherence, quality compliance and development rigor
• Ensure projects within a programme and across the SBI portfolio studies follow R&D best practice planning and control, internal policies and procedures and are regulatory compliant.
• Ensure projects address GARDP objectives regarding AMR related disease burden and global public health impact by having appropriate target product profile and integrated development and access plans.
• Understand regulatory requirements for SBI antibiotic development and play a leading role externally in developing new approaches with key stakeholder (WHO; Regulatory agencies; Antibiotic development partners)
• Ensure the project leads and functional leads are committed to implement studies and other activities that follow international GCP, GARDP SOPs and other relevant regulations.
• Reporting Lines
• Reports into the R&D Director with a indirect line to the Global Access Director
• Line management of project leaders, associate project leaders and specific scientific roles where required
• Access-Led SBI project leads to indirectly report to the SBI Portfolio Head for portfolio level alignment
• Main Interactions
• Works across all R&D teams and GARDP departments in particular Business Development and partner engagement, Global Access, , External Relations, Executive Office, Finance,
• Key relationship with Director of Business Development and partner engagement and team on all aspects of portfolio development and delivery.-
• Responsible as a leading individual in building and maintaining current and future collaborations and frequent interactions with external stakeholders to coordinate provision of work or to advocate, persuade and gain support or commitment.
• He/she represents GARDP for a portfolio/programme area
• Others
• Travel requirements: up to 25%
• Qualification and Competencies

Education and Experience

• Minimum of 12 years' senior experience in drug development (antimicrobials preferred) in pharmaceutical sector, or biotechnology, or non-for-profit global health
• Minimum Ph. D life sciences or medically qualified (MD) with specialism or extensive research experience in infectious diseases, antimicrobial development
• Experience of leading R&D programmes, projects and collaborations with strong evidence of working in partnerships across public and private sectors.
• Significant budget and resource accountability experience

Skills and Attributes

• Excellent ability to lead strategic programs
• Excellent strategic thinking and leadership abilities
• Excellent management, negotiation, and advocacy skills
• Excellent ability to use initiative, prioritize, multi-task, and work well under pressure to meet deadlines
• Excellent analytical skills with ability to assimilate data, recognize key variables, analyze complex situations and lead a team to a consensus position.
• Excellent ability to exercise a high degree of independence to ensure program delivery and explore new areas of activities
• Very clear and systematic thinking that demonstrates strong judgment and problem-solving competencies
• Excellent ability to interact with internal and external stakeholders
• Excellent communication skills in multicultural, multi-lingual environments
• Excellent communication, and public speaking skills, ability to convince and represent GARDP at high level events
• Excellent ability to lead and motivate a team for optimum performance
• Highly organized and structured
• Knowledge of managing global multicultural teams

Closing date for applications

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