Medical Lead
il y a 3 semaines
Medical Lead - Neurology
SUMMARY:
The Medical Lead, Clinical Development will assume a pivotal role in shaping the clinical development strategy for the companies prominent programs and studies. In addition to serving as the medical lead and safety physician, this position will collaborate closely with the companies Clinical Operations team. Working alongside the lead Clinical Trial Manager and the Clinical Research Organisation (CRO), the incumbent will play a key role in the successful execution of clinical studies. This role presents an exceptional opportunity within a dynamic organization, offering the chance to make an immediate impact and grow alongside the company's expanding clinical development enterprise.
DUTIES AND RESPONSIBILITIES:
- Contribute to the formulation and management of the clinical strategy for clinical programs and studies.
- Provide medical oversight for clinical studies, ensuring patient safety, trial integrity, and comprehensive data analysis.
- Develop scientifically sound methods for the design and implementation of relevant clinical protocols, data collection systems, and final reports.
- Lead or assist in the design of clinical development plans and strategies for compounds, therapeutic classes, or indications relevant to the company.
- Draft clinical trial protocols and facilitate efficient review and finalization of protocols and related clinical documents through cross-functional collaboration.
- Collaborate with pre-clinical and translational sciences, as well as senior management, to evaluate requirements for emerging products and business development opportunities.
- Lead cross-functional product development teams, providing guidance and expertise.
- Contribute to the identification, selection, and negotiation processes with clinical research sites and investigators.
- Participate in the selection and oversight of CROs.
- Supervise project team members involved in the planning, implementation, and evaluation of clinical trials.
- Promote fiscal responsibility by managing operational budgets and implementing cost-saving initiatives.
- Uphold compliance with Standard Operating Procedures (SOPs) and policies, ensuring adherence to Good Clinical Practices (GCP) in all responsibilities.
QUALIFICATIONS:
- Must hold a Doctor of Medicine (MD) degree, with a background in Neurology or Psychiatry preferred (Being Board Eligible (BE)/Board Certified (BC) as a Neurologist is advantageous).
- Possesses 3-5+ years of experience in a research organization within the fields of Contract Research Organization (CRO), pharmaceuticals, or biotechnology, with a strong understanding of Good Clinical Practice (GCP). Prior experience in the pharmaceutical industry is highly desirable.
- Has at least 3 years of clinical research experience in the Central Nervous System (CNS) domain, including the ability to create clinical development plans, clinical trial protocols, and other relevant clinical documents.
- Familiarity with working as a medical monitor or safety physician, including the ability to review safety cases and create clinical narratives.
- Exceptional communication and presentation skills, both written and verbal, enabling effective communication with colleagues, business partners, stakeholders, and senior management from diverse backgrounds and cultures.
- Adheres to high ethical and quality standards, demonstrated through actions and communication.
- Proven ability to work independently, seeking guidance when necessary.
- Demonstrated capacity to identify opportunities for ongoing improvement.
- Possesses critical and creative thinking skills.
- Experience working in a dynamic, matrix-based environment.
This position is a hybrid role based in Paris. 3 days in the office, 2 days at home
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