Senior Clinical Development Director - Neuroscience
A leading Swiss pharmaceutical company are currently looking to hire a Senior Clinical Development Director - Neuroscience to be based at their site in Basel. The company employ over 100,000 professionals and have operations in more than 140 countries worldwide. This position is an exciting opportunity to join one of the top 10 global pharmaceutical companies in their medical department.
- Providing clinical leadership and medical strategic input for all clinical deliverables in the assigned project or section of a clinical program if applicable. Clinical deliverables may include clinical sections of individual protocols consistent with the Integrated Development Plans, clinical data review, program specific standards, clinical components of regulatory documents/registration dossiers, and publications.
- Leading development of clinical sections of trial and program level regulatory documents (e.g., Investigator's Brochures, briefing books, safety updates, submission dossiers, and responses to Health Authorities).
- Driving execution of the section of the clinical program in partnership with global line functions, assigned Global Trial Directors, and regional/country medical associates if applicable.
- Supporting (Sr.) Global Program Clinical Head in ensuring overall safety of themolecule for the assigned section, acting as a core member of the Safety Management Team, and supporting overall program safety reporting (e.g., Periodic Safety Update Reports, Drug Safety Update Reports, and other safety related documents), in collaboration with Patient Safety.
- Supporting the Therapeutic Area Head (TAH) by providing medical input into Integrated Development Plans and CTP reviews and contributing/driving development of disease clinical standards for new disease areas. May take on other responsibilities as directed by the TAH.
- As a medical expert, supporting the (Sr.) Global Program Clinical Head or TAH in interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring boards, advisory boards, patient advocacy groups), internal stakeholders (e.g., Clinical Trial Team, Research, Translational Medicine, Global Medical Affairs, Marketing, HE&OR), and internal decision boards.
Skills and Requirements:
- MD or equivalent medical degree required.
- Advanced knowledge and clinical training in neurology required, with Medical Board certification.
- Over 7 years in late or early drug development for psychiatry and/or neurology, orphan indication, or neurodegenerative disease experience preferred.
- Demonstrable ability to establish strong scientific partnership with key stakeholders.
- Thorough knowledge of GCP, clinical trial design, statistical analysis methodology, and regulatory/clinical development process.
- Demonstrable experience in data presentation and strong negotiation and diplomatic skills, experience with health authorities required.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
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 Tom Russell at +34 911 232 071 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.
Proclinical Staffing is an equal opportunity employer.