|Discipline:||Medical & Pharmacovigilance|
|Salary:||£Salary: $300,000 - $330,000 Per annum + bonus, benefits and LTIP|
|Contact name:||Stuart Gilboy|
|Published:||15 days ago|
|Expiry date:||30 April 2021|
The Senior Director, Nephrology Medical Sciences position is responsible as the “portfolio lead” for the Renal/Nephrology clinical development portfolio. Provide medical leadership for the creation and implementation of clinical development strategies for Nephrology assets. This includes each stage of clinical development and NDA/BLA preparation for regulatory submissions and actively look for business development opportunities to expand the company’s portfolio.
Review and develop clinical R&D strategies and participate actively in the design of the clinical components of projects. This entails extensive collaboration with project team members, clinical investigators and external consultants.
Provide medical oversight for nephrology clinical projects. This includes the design and implementation of clinical protocols and data collection systems as well as the preparation of reports.
Utilize a broad understanding of clinical development, regulatory requirements and pre-clinical research data to develop and continually improve the Company’s clinical R&D capabilities. This includes identifying and establishing a strong network of resources, tools, processes and methods.
Develop strategic alliances, which enhance ability to advance drug candidates through product lifecycle phases. This entails interacting effectively with the Company’s R&D staff as well as external collaborators in all aspects of drug development to maximize new product potentials.
Design and implement clinical protocols and data collection such as case report forms; assist in recruiting clinical investigators and negotiate study designs & contractual provisions for conducting trials.
Provide information and expert advice on an ongoing basis to senior R&D and other senior management and participate in the identification, analysis & due diligence research on potential future in-licensed drug candidates as required.
Contribute informed medical information for product documents including INDs, clinical protocols, CRFs, study reports, abstracts, presentations & publications. Participate, as a medical spokes-person, in discussions at conferences, investigator meetings, site visits and with advisory boards.
This position requires a minimum of an M.D. Candidates with a Board Certification in Nephrology/Renal are preferred.
Minimum of five years of experience in the pharmaceutical industry with a focus on clinical development projects in Nephrology.
Experience in writing and managing clinical protocols in Phase I, II and III.
Extensive clinical monitoring experience with an in-depth understanding of the scientific method and clinical development based on scientific and medical principles.
For more information on this company and what is expected in this role together with details of their excellent compensation and bonus scheme please forward an up to date resume to email@example.com
Salary: $300,000 - $330,000 Per annum + bonus, benefits and LTIP
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