EPM Scientific Paris, France
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An Biotech with several first in man / Phase I to III studies is seeking an experience Clinical Development expert to help them with their Clinical Development planning.
This position offers an exciting opportunity in a growing organization with multiple development programs to provide an impact from the start and then grow as the company builds out its clinical development enterprise. This role will act as medical lead on these programs as well as sponsor's safety physician.
As a Medical Director Clinical Development you will be responsible for;
*Contribute to build and manage the clinical strategy lead for clinical programs and studies.
*Perform clinical studies medical monitoring with primary responsibility for patient safety and conduct of assigned trials as well as overall data interpretation and safety surveillance.
*Establish and approve scientific methods for design and implementation of applicable clinical protocols, data collection systems, and final reports.
*Responsible for leading/assisting in design of clinical development plans and overall strategy for compounds, therapeutic classes of compounds or indications in the areas of interest to Bioprojet Pharma.Use a scientific and critical mind to medically review data of the trial, including eligibility review and safety.
*Draft clinical trial protocols and lead cross-functional teams in the review and efficient finalization of clinical protocols and related clinical documents.
*Collaborate with pre-clinical and translational sciences, and senior management in assessing requirements for emerging products of business development opportunities.
*Provide leadership on cross-functional product development team(s).
*Participate in identification, selection and conduct of negotiations with clinical research sites and investigators.
*Participate in the selection and management activities of CROs.
*Supervise project team members in planning, conducting, and evaluating clinical trials.
*Drive fiscal responsibility with the operational budget and cost savings initiatives.
*Maintain compliance with Standard Operating Procedures (SOPs) and policies and perform all duties consistent with Good Clinical Practices (GCP).
The ideal Medical Director will have the following skill set:
*Medical Doctor (MD) required
*3-5+ years of experience in a CRO/pharma/biotech organization with experience
*Experience working in a medical monitor/ safety physician role with demonstrated knowledge of review of safety cases and drafting of clinical narratives.
*Ideally experience working with clinical development such as trial design, development or study protocol writing - this can be as a lead position or supporting.
*Strong verbal and written communication/presentation skills with the ability to communicate to colleagues, business partners, stakeholders and upper management across varied styles and cultures.
*High ethical & quality standards demonstrated through actions and communication.
*Demonstrated ability to work independently and seek guidance, when needed.
*Demonstrated ability to identify opportunities for continual improvement.
*Must think critically and creatively.
*Demonstrated experience working within a fast-paced, matrix environment.
A Medical Director's Package
*Base: Very competitive (above average market rate).
*Continue Career support and development.
*Travel expenses and company car.
*Supportive team
*Gym, child care and relocation support if needed
*Continued career development and opportunities
*Free fruit, tea and coffee.
If interested, please apply via LinkedIn or feel free to reach out directly, all applications are confidential (joana.hembach@epmscientific.com / +49 30 166 370 338 ).
Keyword tags
Medical Director - Clinical Development - Clinical Research Physician - Medical Expert - Clinical Trial Physician - Neurology - CNS- Immunology - Gastroenterology - GI.
Biotech - Pharma - Biotechnology - Pharmaceutical
Paris - France - Hybrid - Global
