[Closing date: 2 March 2016]
The Head of Translation is responsible for advancing the development of new drugs from preclinical research to clinical development working closely with Discovery and Disease area teams. The Head of Translation position will strengthen the quality and progress of DNDi’s clinical candidates working to support drug development and strategies for understanding mode of action, pharmacokinetic/pharmacodynamics readouts, identification of biomarkers, surrogates and clinical endpoints.
She/he will report hierarchically to the R&D Director.
Position based full time in Geneva.
ROLE AND RESPONSIBILITIES:
These may include, but are not limited to:
- Advance the development of investigational drugs by implementing strategies to bridge preclinical research with clinical development and support clinical trials with pharmacodynamic/biomarker
- Provide input in understanding the mechanism(s) of action of DNDi’s therapeutics and candidate therapeutics and develop FIM and phase 1 program accordingly.
- Developing and leading pre-clinical and phase 1 clinical project plans through internal or external resourcing
- Deliver quality decision points and risk mitigation for project progression through pre-clinical and into completion of the phase 1 program and collaborate with Head of the Disease in the development of the clinical strategy
- Support ongoing academic and industry collaborations and any future Open Innovation initiatives through review of proposals, development of full proposals with investigators, and collaborating with investigators on successful proposals
- Implement and manage all aspects of external studies with clinical CROs and investigators in support of portfolio projects (collaborating on experimental design, contracting, compliance, material transfers, etc) in relation with phase 1 studies
- Represent Translational function in assigned projects and cross-functional team and act as subject matter expert for the development team:
- Lead the development of clinical protocols, informed consents, sample collection manuals, as well as regulatory documents for phase 1 studies as well as provide input to Investigator Brochures and dossiers for Agency interactions
- Provide the high quality review and interpretation of study outcomes for assigned studies and oversee the presentation thereof in clinical study reports, and related study documentation to varied team and governance audiences.
- Collaborate with colleagues in R&D Team to advance internal research and early development projects; help/guide DNDi enabling preclinical studies.
- Interface with preclinical and/or clinical collaborators/partners as appropriate.
- Be part of the Disease Extended Teams
- Be part of the Research teams as soon as Candidate nomination
- Present data and conclusions to peers and management, and participate in strategic discussions.
- Maintain a strong understanding and awareness on new and emerging medical and diagnostic developments.
- Liaise with the internal and external medical and R&D community to follow developments within disease areas of interest to R&D.
- Interact with team members in a matrixed environment that includes subject matter experts in clinical, clinical operations, project management, data management, biostatistics, regulatory, commercial, manufacturing, and discovery research.
- Organize project Teams, Departmental and inter-departmental meetings, manage external consultants, contractors and collaborators.
EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES REQUIRED:
- PhD or M.D. /Ph.D.
- At least 10 years of experience, preferably in a biopharmaceutical or CRO environment.
- Drug Development: A broad knowledge of early (Phase I/II) clinical development
- Proven track record of leading successful projects.
- Demonstrated ability to effectively apply technical principles, theories, and concepts, preclinical study designs and clinical drug development
- Proven track record in the clinical space:
- Qualification in pharmacology and its application to early clinical development
- Extensive experience in biomarker/NCE data analysis in the context of mechanism of action studies required.
- Experience in interacting with regulatory agencies (e.g. FDA, EMA).
- Track record in development, implementation and execution of early clinical development strategy for novel drug candidates, from preclinical candidate approval through clinical proof-of-concept.
- Working knowledge of GCP regulations
- Strong interpersonal, writing and presentation skills, the ability to function in a team and matrix management environment, and the ability to represent DNDi to a broad array of leading external collaborators
- Detail-oriented and able to prioritize workload with limited supervision
- Excellent written English communication and oral presentation skills.
- Demonstrated business acumen and ability to think and function independently in a fast-paced environment.
- Flexible personality able to interact with a number of internal and external collaborators of mixed cultures.
- English speaking with knowledge of other language (French, Spanish etc…),
- Will be familiar with pharmaceutical regulatory requirements, documentation and processes for major international agencies
- The Head of Translation will be based in Geneva and must be prepared for work related travels.
Please send via email only a letter explaining why you are applying for this post and an up-to-date copy of your CV/resume to firstname.lastname@example.org . Please indicate in the subject line of your email: Head of Translation
For the full position description and additional information about DNDi please visit our website at www.dndi.org
Accepting applications until 2nd March 2016
Only shortlisted candidates will be contacted.