Chief Medical Officer/Head of Clinical Development

Company: A early/mid-stage biotechnology company developing innovative therapeutic modalities to address unmet medical needs.

Location: California

Reports to: Chief Executive Officer (CEO)

Direct Reports: Clinical Development/Operations team (as it grows), potentially including consultants, CRO partners, and medical/scientific staff.

Position Overview

We are seeking an experienced, strategic, and hands-on physician leader to serve as Chief Medical Officer. The CMO will be the senior medical executive responsible for shaping and executing the company's clinical development strategy, advancing pipeline candidates through clinical stages, and ensuring high-quality, compliant, and efficient development programs. In a small biotech environment, this role combines visionary leadership with direct operational involvement, requiring close collaboration with the CEO, CSO/head of research, regulatory, and external partners (CROs, investigators, KOLs).

Key Responsibilities

• Provide strategic medical and clinical leadership for the company's entire pipeline, defining clinical development plans from IND-enabling studies through proof-of-concept and pivotal trials.
• Oversee the design, planning, execution, and interpretation of clinical trials (Phase 1 through Phase 3, as applicable), including protocol development, endpoint selection, and data analysis strategy.
• Serve as the primary medical expert, ensuring scientific rigor, patient safety, and alignment with regulatory expectations across all development activities.
• Lead interactions with regulatory authorities (e.g., FDA, EMA) including IND/CTA submissions, briefing documents, meeting preparations, and responses to queries.
• Build and manage pharmacovigilance/safety monitoring processes, including oversight of adverse event reporting, DSMBs, and benefit-risk assessments.
• Engage with key opinion leaders (KOLs), investigators, advisory boards, and scientific communities to inform strategy, build credibility, and support trial recruitment and publication efforts.
• Collaborate cross-functionally with research/translational teams to refine target product profiles, biomarker strategies, and go/no-go decisions.
• Contribute to corporate strategy, including fundraising support (e.g., data room preparation, investor/partner discussions), business development, and partnering activities.
• Represent the company externally as the medical spokesperson at scientific conferences, investor meetings, and regulatory interactions.
• Foster a culture of scientific excellence, ethical conduct, and compliance with GCP, ICH guidelines, and applicable regulations.

Qualifications

• MD or MD/PhD required; board certification in a relevant specialty is strongly preferred
• 8+ years of industry experience in clinical development within biotechnology or pharmaceutical companies, with a proven track record of advancing programs from early clinical stages toward registration.
• Direct experience leading clinical trials (as medical monitor or lead) and interacting with regulatory agencies (FDA/EMA experience essential).
• Strong understanding of translational medicine, biomarker development, and clinical trial design across phases.
• Demonstrated ability to thrive in a fast-paced, resource-constrained small biotech environment with a hands-on, entrepreneurial mindset.
• Excellent communication and leadership skills, with experience building relationships with KOLs, regulators, and cross-functional teams.
• Track record of scientific publications, presentations, and contributions to successful INDs, NDAs, or equivalent submissions.
• Ability to travel as needed for meetings, site visits, and conferences.