Associate Medical Director/ Medical Director
About Servier Pharmaceuticals:
We're an organization, committed to modeling diversity, equity, and inclusion for the entire industry, and to maintaining an inclusive environment with equitable treatment for all. We are interested in growing our team with passionate, committed, and innovative individuals. We encourage all to apply to our open roles and are always willing to consider skills and experiences outside of what is listed in the job description.
SUMMARY OF ROLE:
The Medical Director will be responsible for the clinical oncology program in glioma and will partner with the Clinical lead to achieve the program goals. The Medical Director will play a lead role in the study design, protocol development, execution, and supervision of clinical trials as part of the program. This individual will be responsible for ensuring that all clinical studies operate to the highest ethical and safety standards and in compliance with Servier's, GCP and regulatory requirements. The Medical Director will play a key role in contributing to the strategic research and development objectives of the Company. This individual will serve as a liaison between Servier and clinical investigators, and establish and maintain relationships with opinion leaders, trial physicians, and key regulatory officials.
Specific Responsibilities:
Clinical study monitoring:
- Supervise and monitor all phases of clinical trial conduct by working closely with external medical monitors, investigators, and sites to ensure successful medical oversight and consistency in conduct of trials.
- Monitor and evaluate safety signals relevant to clinical programs.
- Work closely with all functions of the organization and external partners to manage trial logistics; work closely with the project management representative(s) to track trial status.
- Work closely with study physicians, as well as other project team members/functional areas to ensure regulatory compliance.
- Contribute clinical expertise to data cleaning activities to ensure integrity of clinical databases.
Clinical Development Strategy and Execution
- Provide medical input and expertise into the strategy, planning, and implementation of Servier programs in clinical development.
- Follow developments and trends in scientific literature and develop/maintain contacts with opinion leaders to gain strategic insights into the further development and positioning of studies within an overall program(s).
- Cultivate relationships and work closely with investigators and academic experts to ensure the scientific and clinical basis of programs and projects; identify opportunities for external collaboration to optimize translational and clinical strategies.
- Travel to scientific meetings, meetings with regulatory agencies, investigators, clinical experts, and other meetings related to duties as described above.
Other duties as required or directed by the Manager or Functional Management
- Write and provide editorial comments for clinical study reports and manuscripts.
- Critically analyze data:
- to develop clinical programs and studies
- for discussion with Regulatory Agencies
- to develop abstracts and manuscripts for publication.
- Support qualification of pharmacodynamics/disease markers for assessing efficacy.
Skills and Education:
Education or Relevant/Equivalent Experience
- M.D. with postgraduate training, ideally board certified or eligible in oncology and/or neuro-oncology, or equivalent experience
Experience in the Pharmaceutical industry and/or other
- 1+ year(s) experience in pharmaceutical industry is desirable.
Demonstrated ability
- Demonstrated understanding of basic science and clinical science as it relates to evaluating potential targets and methodologies
- Demonstrated ability to work in a matrix environment with cross-functional teams
Experience
- Experience working in environments with co-development or partnership arrangements with other companies preferred
Skills
- Excellent interpersonal and public speaking skills; demonstrated ability to present data clearly, concisely and with a clear purpose
- Strong collaborative skills and ability to influence others through effective presentations
- Excellent written communication skills
- Excellent analytical and problem solving skills
Other Relevant Information:
- This position can be remote
- May include 10% travel