Project Team Leader, Late-stage drug development, R&D

(Associate Director, Product Development)

Medicines for Malaria Venture (MMV) is a leading product development partnership (PDP) in the field of antimalarial drug research and development. Our mission is to reduce the burden of malaria in disease-endemic countries by discovering, developing and delivering new, effective and affordable medicines for the treatment and eventual eradication of malaria.

Over the past 18 years, MMV has accumulated a wealth of malaria and R&D knowledge together with industry-style portfolio management. With a track record of success along the drug development continuum and as a node of the largest antimalarial R&D network, MMV is uniquely positioned to play a leading role in the fight against malaria.

We are currently looking for an experienced project leader who will join our Product Development team as a Project Team Leader, Late-stage drug development, R&D (Associate Director). The successful candidate will lead project teams after proof-of-concept stage through drug registration with a stringent regulatory authority. At MMV, project leaders are empowered to deliver on the project strategy and plan with our partners. They are also part of a well-defined internal and external governance structure. We are looking for a professional with a proven record of successful leadership in complex project teams through late-stage drug development. 

The Project Team Leader, Late-stage drug development, R&D will: 
Lead multidisciplinary and cross-organizational project teams
Be responsible for establishing and agreeing a viable project drug development strategy to satisfy MMV Target Product Profile requirements
Provide scientific leadership on different aspects of the project and align relevant team members and experts
Be responsible for preparing data-driven recommendations for MMV management and Joint Steering Committee decisions
Take active part in advisory boards, meetings with regulators and public health officials
Proactively manage collaborations with partners and represent MMV- aligned strategy and implementation
Engage with the selection and management of external vendors as needed
Develop and maintain an approved project plan and associated budget
Be accountable for delivering on project plan according to timelines, budget, operational procedures, Quality standards, and for reporting progress to MMV donors
Be responsible for successful transition of projects to the Access and Product Management project leader and continue to serve as a team member
Ensure accuracy of all internal and external communications relating to the project/product
Education and Experience:
PhD in life sciences
Minimum 8-10 years of drug development experience at a pharmaceutical or biotech company
Must have >5 years of experience in leading complex cross-organizational projects in late-stage development (phase II and III); registration experience desired
Demonstrated success in positions involving influencing and negotiation
Experience in anti-infective therapeutic area, drug combination development and pediatric therapeutics is desired

Technical skills required:
Proven ability to successfully lead multiple projects in a drug development environment
Scientific expertise in late-stage drug development with emphasis on clinical and regulatory aspects
Broad working knowledge of non-clinical, formulation development, Chemistry, Manufacturing & Controls (CMC) and other aspects of drug development
Experience in working with market access and product management groups to align drug development strategy with target product profiles
Knowledge of ICH / GCP & GMP guidelines
Fluency in English (oral and written)
Familiar with common computer statistical, technical, and database applications
Behavioural skills required:
Strong strategic thinking and analytical skills with mature negotiation and influencing skills
Energy and drive to fuel strong results orientation
Mentor team members to be effective in their roles and responsibilities
Strong collaboration and interpersonal skills; ability to work with people from different functions and background with tact and diplomacy
Top class verbal and written communication skills including well-structured presentation skills appropriate for a senior management forum
Organizational skills, project management skills and attention to details
Ability to cope with stress and time pressure
Willingness to travel as necessary according to projects needs
Start date: As soon as possible
Interested applicants should apply at:

https://mmv77988.recruiterbox.com/jobs/29c167a568c943c38839d3155b50361b