Director Clinical Development Respiratory
ProClinical is working with a world leading biotechnology company that is seeking a Director of Clinical Development to be based in Cambridge, Uk on a permanent basis.
- 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.
- Provide medical input to preclinical research teams to support optimal development of potential new products.
- Represent the company to external opinion leaders and at conferences.
- Develop and manage a network of external experts relevant to the company's development programmes and seek out competitor intelligence.
- Serve on internal committees, as requested/required.
- Attend appropriate scientific meetings to maintain his/her awareness of research activities in his/her area of expertise.
- Assume other duties as assigned by the Senior Director of Vice President.
Skills and Requirements:
- MD, board certified (or eligible) in allergy/immunology or pulmonary disease
- 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.
- Demonstrable evidence of working collaboratively within a matrix team environment.
- 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
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 call Tom Russell on +44 203 8246 104 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.
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