Senior / Executive Director, Medical Director, Rheumatology

Crystalys Therapeutics, is a dynamic, startup, San Diego biotech organization focused on advancing innovative therapies in rheumatology through Phase 2 and Phase 3 clinical trials. They have completed their series A financing with a runway into the middle of 2028.

The Sr. or Executive Medical Director will serve as a senior clinical leader within this organization and will be responsible for shaping and executing the clinical development strategy, providing expert medical oversight, and ensuring scientific and regulatory excellence across all studies. Ideally, this is a Hybrid role (located in San Diego, CA)

As a key member of the team, the Sr. or Executive Medical Director will collaborate cross-functionally with Clinical Operations, Regulatory Affairs, Biometrics, and other members of the Clinical development team to drive successful trial execution and support regulatory submissions. The ideal candidate will bring deep expertise in rheumatology, a strong understanding of clinical trial design and execution, and a passion for improving patient outcomes through novel therapeutics.

ACCOUNTABILITIES

• Lead study specific clinical development teams and be responsible for all clinical deliverables in the assigned project and section of a clinical program
• Drive protocol implementation, through assisting in site identification and communication, attendance at investigators' meetings, and interaction with Operations team members and the CRO medical team
• Medical Monitor for clinical trials, including the oversight of all aspects of trial conduct and safety, contact with investigators and site study staff
• Provide support in ensuring the overall safety of subjects participating in clinical trials
• MD, DO, or equivalent medical degree; board certification preferred.
• Minimum of 10 years of clinical experience, with at least 5 years in a leadership role.
• Proven track record in clinical strategy, regulatory affairs, and cross-functional collaboration.
• Strong communication, analytical, and decision-making skills.
• Experience in clinical research, drug development, or healthcare innovation is a plus.
• Support interactions with external and internal stakeholders and internal decision boards
• Support data analysis and assembly, including clinical study report writing and preparation of abstracts, presentations and manuscripts
• Interact closely with the regulatory group and agencies and take part in IND submissions, investigator brochure authorship and communication international regulatory agencies
• Oversee and conduct ongoing medical and scientific review of clinical trial data

QUALIFICATIONS

Compensation range : $285,000 - $350,000