Senior Translate Manager
An international research organisation is seeking to recruit a Senior Translate Manager to their office in Geneva. The company specialises in developing safe, effective, and affordable treatments for millions of people across the world being affected by neglected diseases, including paediatric HIV and hepatitis C. This is an exciting opportunity to work with a notable and prestigious organisation and significantly bolster a career in the regulatory field.
- 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 therapeutics and candidate therapeutics and develop FIM and Clinical Pharmacology program accordingly
- 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, Regulatory submission, etc) in relation with phase 1 studies and be accountable for the study budget
- Participates to Site / CRO selection through bidding process and contribute to the Clinical Trial Application submission to Competent Authorities and Ethics Committees (Set-Up Phase)
- Ensures adequate document control for all trial documents, monitor milestones, compliance and budget and presents the clinical trial progress to applicable team
- As medical responsibilities (responsibilities of Study Medical Responsible)
- S/He produces the Medical Monitoring Plans for Phase 1 study, with support from the CPM, HDCP, Head of Translation Sciences (as appropriate), Pharmacovigilance function, data management and other function as required.
- S/He defines the Medical Review Specification (MRS) contained within the Medical Monitoring Plan and the Data management Plan
- S/He performs the Medical Monitoring according to the Medical review specification
- S/He contributes to the appropriate safety management by clinical trial teams as defined in the protocol, monitoring plan and medical monitoring plan (if any) in compliance with the trial-specify safety management plan.
- S/He participate as a member of Safety Review Committee to review Safety and Pharmacokinetics data and to decide as required about dose-escalation
- S/He will have a dotted reporting line to the Medical Director
- Represents 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
- Interface with preclinical and/or clinical collaborators/partners as appropriate.
- Be part of the Disease Extended Teams
- Maintains a strong understanding and awareness on new and emerging medical and diagnostic development.
- Reports Major and Critical deviations to the QA unit and develops or reviews the CAPA, in addition to informing the Direct manager, performs an Investigation and Root Cause Analysis in case the significance of the deviation is confirmed by QA and oversees the implementation of all CAPAs
Skills and Requirements:
- Advanced post graduate degree or graduate degree with equivalent in experience to reach Master level.
- Medical doctor.
- Drug Development: A broad knowledge of early clinical (Phase I/II) development
- 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
- Experience in interacting with regulatory agencies (e.g. FDA, EMA).
- Experience in biomarker/NCE data analysis in the context of mechanism of action studies.
- Familiar with pharmaceutical regulatory requirements, documentation and processes for major international agencies
- 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.
- Excellent knowledge of Drug Discovery/Development
- Excellent knowledge of Clinical Research/Development
- Excellent knowledge of Regulatory (GCP, GLP and GMP)
- Strong knowledge of Disease/academia knowledge
- Excellent Technical writing skills (procedures, protocols and reports)
- Over 8 years in Senior role
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Sasha Brasero at +44 203 078 9556 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
£0.00 - £350 per hour
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