Hobson Prior are looking for a Senior Translation Manager to join a drug research and development company on a permanent basis. Our client concentrates on delivering pioneering treatments for illnesses that are mistreated.

Job Responsibilities:

• Advance the development of investigational drugs by executing strategies to bridge pre-clinical research with clinical development and support clinical trials with pharmacodynamic/biomarker.
• Deliver input in understanding the mechanisms of action of the organisations therapeutics and candidate therapeutics and develop FIM and Clinical Pharmacology programme accordingly.
• Develop and lead pre-clinical and Phase I 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 I programme and as required.
• 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.
• Execute and manage all aspects of external studies with clinical CROs and investigators in support of portfolio projects.
• Contribute to site/CRO selection through bidding process and contribute to the Clinical Trial Application submission to Competent Authorities and Ethics Committees.
• Ensure adequate document control for all trial documents, monitor milestones, compliance, and budget, and present the clinical trial progress to applicable team.
• Defines the Medical Review Specification contained within the Medical Monitoring Plan and the Data Management Plan.
• Lead the development of clinical protocols, informed consents, sample collection manuals, as well as regulatory documents for Phase I studies as well as provide input to Investigator Brochures and dossiers for Agency interactions.
• Deliver 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.
• Participate to interim and final data analysis, coordinate data base locks, and release of results (e.g. data cleaning, medical review).

Key Skills:

• Strong capability to use initiative, prioritize, multi-task, and work well under pressure to meet deadlines.
• Clear and systematic thinking that demonstrates strong judgment and problem-solving competencies. Excellent communication skills in multicultural, multi-lingual environments.
• Ability to work effectively as part of a multicultural team.

Requirements:

• Over 8 years in Senior role.
• Proven ability to work effectively in a team environment and matrix structure.
• Experience of working in public and private sector is highly desirable.

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.