The Medical Director is a core member of the Company's senior leadership team. The Medical
Director is responsible for providing medical and scientific guidance, management and strategic
direction related to the Company's current and future participation in clinical trials, and to
achieving the Company's strategic growth plans and business objectives.
The position is office-based at the Company's clinic in San Diego, CA.
Key Functions and Responsibilities:
The Medical Director provides direct management, leadership, training, and oversight of the
Company's employed investigators.
The Medical Director builds and manages relationships with the Company's contract partner
investigators and provides study-related oversight to this group as needed.
The Medical Director serves as Principal Investigator or as Sub-Investigator depending on the
circumstances of certain trial opportunities and business needs and objectives as they relate to
acquiring study opportunities.
The Medical Director provides medical and scientific expertise and guidance through close
collaboration with the Company's Clinical Operations leadership and staff.
The Medical Director has an active role in the Company's growth objectives, supporting
business development activities in the development of new client relationships and
strengthening existing relationships to expand the Company's portfolio of investigators, studies,
clients, and therapeutic area experience and expertise.
The Medical Director also assists in building and managing positive relationships in the clinical
research community to increase the Company's visibility, reputation, and stature consistent
with that of an employer and partner of choice.
Qualifications:
MD, DO, or equivalent medical degree with active and unrestricted medical license.
Ten or more years of high-quality, multi-therapeutic clinical research experience as a Principal
Investigator in a leadership role.
In-depth knowledge of ICH-GCP, FDA regulations, and clinical trial operations.
Strong leadership, organizational, and communication skills.
Ability to engage effectively with other physicians, sponsor and CRO contacts, and
other key stakeholders to drive business growth.
Some travel required including site visits, board meetings, client meetings and industry
conferences.
General Responsibilities as Principal Investigator (PI):
Assist in feasibility assessments of new clinical study opportunities, evaluating protocol
requirements, enrollment potential, and execution strategies.
Provide medical and scientific expertise throughout the business development process, from
lead generation to study award and repeat business opportunities.
Ensure patient safety, rights, and confidentiality while upholding compliance with ICH-GCP
guidelines.
Oversee data integrity, protocol adherence, and timely reporting of study results.
Train and support research staff to minimize protocol deviations and enhance study execution.
Administer study drugs and perform required physical assessments.
Report Serious Adverse Events (SAEs) and other safety concerns to sponsors and regulatory
agencies per guidelines.
Participate in investigator meetings, inspections, audits, and monitoring visits to ensure study
integrity and regulatory compliance.
Support patient recruitment efforts by engaging with healthcare providers and community
organizations.
General Responsibilities as Sub-Investigator:
Assist the PI in maintaining study oversight and ensuring compliance with ICH-GCP and sponsor
expectations.
Conduct study-related procedures, including participant eligibility assessments, medical
evaluations, and adverse event monitoring.
Administer study drugs and monitor patient adherence to protocol requirements.
Contribute to recruitment initiatives, including pre-screening activities and presentations to
healthcare professionals.
Participate in study-specific training, inspections, audits, and monitoring visits.
Maintain accurate and comprehensive study records in compliance with regulatory and sponsor
requirements.