Hobson Prior is currently recruiting for a new and exciting vacancy for a Director, Clinical Development (Physician) to work at an innovative UK-based biopharmaceutical company that specialises in R&D for multiple therapeutic areas, including respiratory, cardiovascular and metabolic diseases and oncology.
- Lead Clinical Sub Teams of Product Development Teams.
- Develop, or supervise development of, Clinical Development Plans for potential products, and present such plans to governing bodies.
- Develop or supervise development of, trial synopses, protocols and protocol amendments.
- Be accountable for the ethical and scientific integrity of the plans and studies.
- Be responsible for the preparation of medical components of Investigator Brochures, ethics, IND and other regulatory communications.
- Provide medical input to the conduct of clinical trials in a proactive Good Clinical Practice Environment.
- Provide medical and specialty expertise for safety surveillance and interact closely with the Safety group to ensure patient safety throughout the entire clinical development process. Assist with the development of the benefit risk analysis and patient risk management plans.
- Collaborate with project team members in planning, conducting and evaluating clinical trials.
- Collaborate with Translational Science to optimise approach to study target inhibition and to understand mechanism of action of products in early clinical development.
- Oversee planning and management of Investigator meetings, advisory boards and other scientific committees, as required by the protocol (e.g. independent reviews, DSMBs etc.).
- Interpret trial data to support decision making.
- Lead development of clinical publications of trial results.
- Provide clinical input to help evaluate and prioritise new product development opportunities, both internal and external.
- Ability to establish and maintain productive working relationships, both within the organisation and externally.
- Enthusiastic, adaptable and flexible approach.
- Proven planning skills.
- Excellent communication skills at all levels, both internally and externally and across different functions, plus the ability to make effective presentations.
- Self-motivated and able to motivate others.
- Ability to lead a team and support other team members.
- Ability to thrive in an innovative, entrepreneurial environment.
- MD, board certified (or eligible) in allergy/immunology or pulmonary diseases.
- Specialty training in respiratory is mandatory.
- Experience in early (Phase I/II) Clinical Development.
- Ability to draw on previous clinical research experience to design clinical development plans, to plan and lead studies, to anticipate potential problems and to take appropriate action, with an appropriate level of consultation, in order to meet agreed timelines and costs.
- Proven leadership skills.
- Sound knowledge of relevant guidelines and standards.
- Experience of incorporating translational medicine approach into early clinical development would be a plus.
- Experience of working with opinion leaders and external consultants.
- Good working knowledge of ICH GCP requirements and understanding of regulatory requirements.
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 science recruiter focussed 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.