Medical Director, Clinical Development

Alterome Therapeutics • San Diego, CA

70d

About The Position

We are seeking a highly motivated Medical Director, Clinical Development to lead the execution of our early-stage clinical programs (Phase I-II) who will report directly to the VP, Clinical Development. This individual will serve as the primary sponsor representative overseeing outsourced clinical trials run by CRO partners, ensuring scientific integrity, patient safety, and operational excellence. In our entrepreneurial environment, the Medical Director will be both strategic and hands-on, playing a central role in shaping our clinical development path while collaborating closely with internal stakeholders and external experts. The ideal candidate will work in our hybrid office a minimum of 3 days per week.

Requirements

• M.D. degree
• 3+ years of industry experience in clinical development, with direct involvement in Phase I-II oncology trials.
• Knowledge and experience in solid tumor clinical trials preferred
• Understanding of drug development process
• Demonstrated success working with and managing CROs and vendors.
• Experience authoring and reviewing protocols, regulatory documents, and clinical trial submissions preferred.
• Knowledge of GCP, ICH guidelines, and U.S. and EU regulatory requirements.
• Highly motivated with demonstrated track record of high performance and excellence
• Strong strategic skills including creativity and effectiveness in proactively identifying and addressing challenges
• Strong interpersonal skills and excellent verbal communication and presentation skills.
• Well-organized with the ability to be flexible, prioritize multiple demands, and effectively lead in a matrix organization

Nice To Haves

• Experience authoring and reviewing protocols, regulatory documents, and clinical trial submissions preferred.
• Knowledge and experience in solid tumor clinical trials preferred

Responsibilities

• Contribute to the design and implementation of clinical development plans, protocols, and study designs in alignment with corporate goals and regulatory expectations.
• Draft and review study-related documents including protocols, investigator brochures, IND amendments, and clinical sections of regulatory submissions.
• Support the VP, Clinical Development in preparing presentations for executive leadership, board meetings, and scientific/medical forums.
• Act as sponsor lead for Phase I-II trial(s), ensuring compliance with protocol, GCP, and regulatory standards.
• Provide day-to-day oversight of study conduct and collaborate with internal cross-functional teams, CROs and other external vendors (eg, clinical operations, regulatory, data management, biostatistics, pharmacovigilance, medical writing).
• Partner with pharmacovigilance providers to ensure accurate, timely safety reporting.
• Collaborate with Clinical Development Scientist team to ensure timely review of data listings, safety reports, and interim analyses to support timely, data-driven decisions.
• Monitor trial progress and timelines proactively to identify and mitigate risks.
• Participate in safety monitoring activities, including clinical review of adverse events, dose-escalation discussions, and safety data reconciliation.
• Provide medical/scientific guidance to investigators and clinical sites.
• Engage with key opinion leaders (KOLs) and investigators to inform study design and program advancement.
• Contribute medical and scientific expertise to publications, abstracts, and presentations.

What This Job Offers

• Industry: Chemical Manufacturing
• Education Level: Master's degree
• Number of Employees: 11-50 employees