ProClinical is currently seeking a highly motivated, dynamic leader who wants to be part of a team with cutting edge science and a passion for delivering medical innovation to patients with unmet medical needs. This Head of Clinical Development role will be placed in a privately held, clinical stage biotechnology company focused on developing breakthrough therapies for severe neurological disorders. This companies focus is on lysosomal storage diseases with significant CNS sequalae.
The Head of Clinical Development will be responsible for the overarching clinical development strategy, and the successful execution of clinical trials. The candidate will also interface with the regulatory authorities (FDA, EMA), and build relationships with scientific and medical communities as well as patient advocacy groups.
- Develop strategy and lead execution of clinical research programs, comprising internal and external teams, consultants and advisors. Integrate scientific rationale, regulatory requirements, risks, and product development to build a solid strategic framework.
- Ensure patient safety in studies through excellence in design and ongoing safety and medical monitoring.
- Provide medical and scientific expertise for the interpretation of scientific concepts and data, and interpretation of study results.
- Maintain and expand strong collaborations, relationships with investigators, advisors and patient advocacy groups.
- Prepare the department budget and forecast resources needed, including hiring of key talent
- Clinical and scientific reviewer of all company scientific publications and product labelling.
- Be an inspirational member of the leadership team, helping set company business strategy, methods of operation and policies and communicate the company's vision
Skills and Requirements:
- MD strongly preferred or PhD with extensive experience in clinical programs/development, with 10+ years of relevant professional experience in the development of investigational new drugs. Pharmaceutical/Biotech industry experience preferred.
- Ability to engage with individuals across a wide range of professional and cultural background (e.g. clinicians, patient advocacy groups, investors)
- Experience in designing, conducting, and reporting phase 1-3 clinical trials.
- Regulatory submission experience in US and Europe will be an advantage.
- Excellent communication, organization and management skills.
- Demonstrates flexible work style, initiative and good business judgement.
- Proven track record of delivering results and demonstrating a sense of urgency.
- Experience in lysosomal storage disease or breakthrough therapies preferred.
- Ability to travel (20%)
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 Darren Whyte on +1 646 542 0158 or upload your resume 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.