Medically-qualified, the Senior Director of Translational Medicine is a strategic and highly influential position and will provide valued clinical project leadership and technical expertise, acting as the key catalyst for Gyroscope’s global early phase clinical development programmes in the Ophthalmology therapy area. The Senior Director of Translational Medicine will report to the Chief Medical Officer (CMO) and work closely with both the Clinical Development and the Research teams.
The successful candidate will be involved in a wide range of early R&D pipeline projects working in close collaboration with Research/Preclinical, Clinical Development (CD) functions, Regulatory Affairs, Product Development, Commercial/ Business Development and Project Management. The Senior Director of Translational Medicine will collaborate with the clinical development team to develop early clinical development plans for assigned projects and will be expected to establish strong relationships with senior external experts, providing leadership for first-in-human (FIH) study conduct and, when required, lead Early Clinical Development’s FIH Committee.
Main Responsibilities and Accountabilities
- Serve as the lead strategic voice for translational medicine within the extended leadership team;
- Responsible and accountable for developing the early development strategy and plan;
- Support ambassadorship of Gyroscope by attending, preparing and presenting where appropriate at scientific conferences;
- Lead due diligence efforts on behalf of Gyroscope to assure pursued assets are consistent with the scientific and business objectives of the company;
- Mentor and manage medical direct reports within Translational Medicine function;
- Provide medical and disease area knowledge in support of projects in the early R&D pipeline;
- Work closely as a member of the leadership team to build medical and clinical leadership capabilities within the function;
- Provide and/or oversee medical leadership for Early Development programs from to POC. Develop and oversee innovative early clinical development (including translational science and experimental medicine) strategies to evaluate functional relevance of targets in human disease;
- Oversee and/or devise, lead and implement innovative and industry-leading early clinical development plans, ensuring cross-functional engagement and alignment of strategies with Commercial needs;
- Ensure high functioning Clinical Development Teams (CDT);
- Work closely with the Translational Science group to ensure that clinical assay and Translational Science/biomarker plans are well positioned to support the asset and asset strategy/plan, peer reviewed, endorsed and integrated into the early Clinical Development Plan. Support qualification of pharmacodynamics/disease markers for early assessment of clinical outcomes;
- Work closely with experts within Clinical Pharmacology & Pharmacometrics to have pharmacokinetic and pharmacometric aspects of assigned projects fully covered and integrated into clinical plans;
- Oversee conduct of early clinical (including FIH) studies within the target assets: ensure close cross-functional engagement;
- Lead clinical input into indication selection and development of Target Product Profiles for early projects;
- Lead or oversee the design and protocol development for an early (Phase Ia/Ib and/or Phase IIa) clinical study in collaboration with the clinical development team;
- Lead or oversee clinical contributions to regulatory documents, including Investigator Brochures and dossiers for Agency interactions. Leads the resolution of clinical queries from regulatory agencies for assigned studies;
- Lead the high quality review and interpretation of study outcomes for assigned studies and oversees the presentation thereof in clinical study reports, related study documentation, and to varied team and governance audiences;
- Maintain a strong understanding and awareness on new and emerging medical developments. Liaise with the medical community to follow developments within disease areas of interest to R&D. Support due diligence of external assets for potential in-licensing and/or acquisition.
Skills and Experience
- 10+ years of industry-specific experience in pharmaceutical and/or biotech companies;
- Experience with translating preclinical programmes into clinical development;
- Professional credentials as a physician or equivalent (MBBCh, MD, etc);
- Significant experience of early clinical development, Phase ½;
- Demonstrable expertise relating to all aspects of the drug development process and the ability to identify and resolve complex methodological issues relating to programs;
- Proven track record developing and managing R&D strategic and operating plans and budgets, as well as managing a team in a biotech environment;
- Experience in managing multiple, concurrent projects;
- Knowledge of international clinical trial approval processes;
- Experience in presenting the clinical development strategy to competent authorities (for example, FDA, EMA, national agencies);
- Knowledge of guidelines and other regulatory requirements, especially FDA and EMEA;
- Experience in running gene therapy trials an advantage.
- Ability to be both strategic and hands-on, adaptable to small/medium size pharma companies;
- Excellent oral and written communication skills as well as the ability to facilitate analysis and problem solving through the effective facilitation of group activities;
- Strong organisational and time management skills including the ability to function effectively in a team environment;
- Demonstrated professionalism and adherence to high ethical standards;
- Demonstrated ability to manage multiple priorities to achieve results and meet milestones.
- Competitive salary, dependent on experience
- Bonus and share options