Crystalys Therapeutics
Senior / Executive Director, Medical Director, Rheumatology
Crystalys Therapeutics, San Diego, California, United States, 92189
Senior / Executive Director, Medical Director, Rheumatology
Crystalys Therapeutics, a dynamic startup San Diego biotech organization, is focused on advancing innovative therapies in rheumatology through Phase 2 and Phase 3 clinical trials. The Sr. or Executive Medical Director will serve as a senior clinical leader, shaping and executing the clinical development strategy, providing expert medical oversight, and ensuring scientific and regulatory excellence across all studies. This is a Hybrid role located in San Diego, CA. The ideal candidate 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. They should 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, including site identification and communication, attendance at investigators’ meetings, and interaction with Operations team members and the CRO medical team Act as Medical Monitor for clinical trials, overseeing all aspects of trial conduct and safety, and interact with investigators and site study staff Ensure the overall safety of subjects participating in clinical trials Provide support for 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 participate in IND submissions, investigator brochure authorship, and communication with international regulatory agencies Oversee and conduct ongoing medical and scientific review of clinical trial data Qualifications: 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 Compensation range: $285,000 - $350,000
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Crystalys Therapeutics, a dynamic startup San Diego biotech organization, is focused on advancing innovative therapies in rheumatology through Phase 2 and Phase 3 clinical trials. The Sr. or Executive Medical Director will serve as a senior clinical leader, shaping and executing the clinical development strategy, providing expert medical oversight, and ensuring scientific and regulatory excellence across all studies. This is a Hybrid role located in San Diego, CA. The ideal candidate 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. They should 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, including site identification and communication, attendance at investigators’ meetings, and interaction with Operations team members and the CRO medical team Act as Medical Monitor for clinical trials, overseeing all aspects of trial conduct and safety, and interact with investigators and site study staff Ensure the overall safety of subjects participating in clinical trials Provide support for 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 participate in IND submissions, investigator brochure authorship, and communication with international regulatory agencies Oversee and conduct ongoing medical and scientific review of clinical trial data Qualifications: 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 Compensation range: $285,000 - $350,000
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