Lead and drive clinical development strategy for key programs. Act as the medical lead and sponsor's safety physician, collaborating closely with Clinical Operations, Trial Manager, and CRO for effective study delivery. Join a dynamic and growing organisation, contributing to impactful development programs and growing with the company's expanding clinical development enterprise. Exciting opportunity to make a significant impact from the start.
Responsibilities:
* Contribute to building and managing the clinical strategy for clinical programs and studies.
* Perform medical monitoring for clinical studies, with a focus on patient safety and trial conduct.
* Interpret overall data and oversee safety surveillance in assigned trials.
* Establish and approve scientific methods for designing clinical protocols, data collection systems, and final reports.
* Lead or assist in designing clinical development plans and strategies for compounds or therapeutic classes.
* Draft clinical trial protocols and efficiently finalise clinical documents through cross-functional collaboration.
* Collaborate with pre-clinical, translational sciences, and senior management in assessing product requirements.
* Provide leadership on cross-functional product development teams.
* Identify, select, and negotiate with clinical research sites and investigators.
* Participate in selection and management activities of Contract Research Organisations (CROs).
* Supervise project team members in planning, conducting, and evaluating clinical trials.
* Drive fiscal responsibility with operational budget management and cost-saving initiatives.
* Ensure compliance with Standard Operating Procedures (SOPs) and policies, adhering to Good Clinical Practices (GCP).
Requirements:
* Medical Doctor (MD) required, Neurology or Psychiatry experience preferred (Board Eligible/Board Certified Neurologist a plus).
* 3-5+ years of experience in CRO/pharma/biotech organizations, GCP expertise; pharmaceutical experience highly desired.
* 3+ years of Central Nervous System (CNS) clinical research experience, capable of drafting clinical development plans and protocols.
* Proficient in medical monitoring/safety physician role, with expertise in reviewing safety cases and drafting clinical narratives.
* Strong verbal and written communication skills for diverse audiences, including colleagues, stakeholders, and upper management.
* High ethical and quality standards demonstrated through actions and communication.
* Ability to work independently and seek guidance when needed.
* Proven critical and creative thinking skills.
* Experience in identifying opportunities for continual improvement.
* Demonstrated ability to thrive in a fast-paced, matrix environment.
Work Environment:
Based in Paris
Languages:
French
English
