MMV is a leading product development partnership (PDP) in the field of antimalarial drug research and development. Its mission is to reduce the burden of malaria in disease-endemic countries by discovering, developing and delivering new, effective and affordable antimalarial drugs. Over the past 17 years, MMV has worked with an extensive network of donors, private and public sector partners, experts and clinical centres in endemic countries to develop an outstanding portfolio of antimalarial projects.
MMV is seeking a Director, Non-Clinical Pharmacology and Toxicology who will design and ensure the execution of preclinical studies to determine the efficacy and safety of drug combinations and support MMV and its partners in the selection of suitable drug combinations to progress into clinical studies in accordance with MMV’s strategy. They will collaborate with academic and industry experts to expand and develop innovative non-clinical models for the selection of drug combinations to meet MMV’s Target Product Profiles. They will also be responsible for the design, conduct, and reporting of non-clinical toxicology and PK studies to support programmes within MMV’s translational portfolio.
This is a a functional leadership role, as the Director will be instrumental in setting our strategy for the data-driven selection of drug combinations and in developing criteria to prioritise and progress drug combinations to clinical development.
Primary duties and responsibilities:
- Develop and direct the in vivo pharmacology strategy in view of MMV’s development portfolio, focusing on prioritisation of combinations
- Provide strategic and scientific guidance in the design of non-clinical combination pharmacology studies to support accelerated development in line with Stringent Regulatory Authority guidelines
- Ensure appropriate resources for, and lead all preclinical toxicology and safety pharmacology activities to support initial first-in-human evaluations
- Working together with MMV’s Discovery team, academia and industry partners, develop experimental models to study combinations for chemoprophylaxis/chemoprotection and transmission-blocking
- Collaborate with MMV pharmacometrics to interpret the results of combination pharmacology studies. Present non-clinical findings to the MMV Global Safety Board
- Manage consultants and provide oversight for the timely assessment of non-clinical GLP, safety, pharmacology and toxicology studies in preparation of first-in-human studies
- Oversee the timely assessment of repeat toxicology studies to support multiple dose, or long acting injectables. Ensure EFD and juvenile toxicology studies are completed early to prioritise compounds which could be used in children and pregnant patients
- Review the results of non-clinical toxicity assessments and advise project teams
- Contribute to the preparation and review of regulatory documentation
- Maintain and develop the network of providers and experts for non-clinical toxicological evaluation and assessment of new molecules, and work closely with MMV’s Business Development team in the selection of contract research organizations
Education and Experience:
- Doctorate degree in biology, biochemistry, toxicology, veterinary medicine or related subject
- Minimum 10 years’ experience in non-clinical pharmacology in disease models and/or toxicology, preferably with time spent in a pharmaceutical or biotech company, with at least 3 of those years in a similar functional leadership role
- A strong track record of regular interactions with regulatory agencies e.g. pre-IND
- Experience in the development of combination therapies
- Experience in infectious disease is an asset, particularly in malaria parasitology
Technical skills required:
- Proficiency with Windows-based Microsoft programmes
- Fluent in English (oral and written)
- Knowledge of FDA and EMA regulatory requirements and OECD GLP & ICH/GCP guidelines
Behavioural skills required:
- Self-motivated and capable of handling significant responsibility as well as shifting priorities
- Management style that is supportive and sets clear expectations, delegates responsibility and instils an accountability for quality
- Analytical thinker with excellent problem solving skills and the desire to foster a structured methodology and to improve processes
- Detail-oriented with strong organizational and time management skills, including the ability to support and prioritize multiple projects
- Strong written and verbal communication, including presentation skills
- Ability to work well with all levels of collaborators, across all cultures
Start date: January 2018
Interested applicants should send their CV and a cover letter giving reasons for their interest in the position to jobs [at] mmv.org before 20 October 2017. Please refer to the following code in the subject line of your email: RD-2017-16.
Recruitment agencies are kindly requested to refrain from submitting applications.