- Lead medical monitoring of Phase 1 studies, fostering significant interaction with clinical sites.
- Create essential clinical documents, including protocols and Investigator Brochures.
- Collaborate with internal and external stakeholders, including clinical investigators, scientists, and external experts, to develop clinical strategy.
- Participate in or present at scientific advisory boards and conferences.
- Serve as a clinical representative or lead on Project Teams and sub-teams.
- Contribute to Business Development activities, including due diligence exercises and strategic partnerships.
- Support preparation for regulatory meetings with Healthcare Authorities and participate as needed.
- Represent key opinion leaders, clinical sites, and other stakeholders with integrity and professionalism.
- Ensure compliance with all governing laws, regulations, SOPs, and relevant guidelines.
- Board-certified (or eligible) Medical Doctor, preference for certification in Neurology or Immunology; Ph.D. or additional degrees are a plus.
- Strong therapeutic experience, with a minimum of 3 years in direct industry experience (Director-level; 6 years Sr. Director-level) managing clinical trials.
- Background in basic, translational, or clinical research in academia or industry.
- Understanding of clinical drug development, especially phase I and II studies.
- Demonstrable ability to strategize, design, implement, and oversee clinical development plans, trials, and programs.
- Ability to thrive in a fast-paced, entrepreneurial environment, working collaboratively and independently under broad strategic guidance.
- Well-versed in GCP, ICH, FDA, EMEA, NICE, and other relevant guidelines and regulations.
- Sound business acumen with knowledge of multi-disciplinary functions involved in a company's drug development process.
- Exceptional interpersonal skills and the ability to collaborate with key stakeholders, developing strong relationships with partners, thought leaders, and national advocacy and disease organizations.
Vice President - California, United States - Meet
Description
Meet has partnered with a clinical-stage biotechnology company dedicated to advancing precision medicines for genetically defined neurological and immunological diseases. They are currently seeking a skilled and experienced drug development physician to join their dynamic team.
Reporting directly to the Chief Medical Officer, this individual will play a pivotal role in designing clinical studies, developing protocols, and acting as a medical monitor across their preclinical and clinical programs. Collaboration is key, as the successful candidate will actively engage with external partners to plan and execute early-stage clinical trials while contributing to innovative trial design in a cross-functional environment.
Principal Accountabilities:
Qualifications: