Chief Medical Officer
TwoStep Therapeutics
full-time
Posted on:
Location Type: Hybrid
Location: SF Bay Area • California • United States
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Job Level
About the role
- Lead the overarching clinical development strategy and execution for the pipeline, ensuring seamless alignment with corporate goals, scientific innovation, and long-term patient impact.
- Serve as the primary medical expert for novel therapeutics to deliver rigorous, high-quality clinical, scientific, and regulatory outcomes.
- Collaborate closely with R&D, and external partners to align clinical strategies with corporate priorities, manufacturing capabilities, and development plans.
- Lead the preparation, review, and submission of critical regulatory documents (e.g., protocols, Investigator's Brochures) to enable efficient early-phase clinical development.
- Cultivate and maintain relationships with Key Opinion Leaders (KOLs), academic investigators, advisory boards, CROs, and trial sites.
- Engage effectively with investors, board members, and external stakeholders to communicate program progress, scientific rationale, and strategic value.
Requirements
- Education: MD with board certification in a relevant specialty (e.g., oncology, nuclear medicine, radiation oncology, or related therapeutic area).
- 15+ years of progressive clinical leadership experience in the biotech or pharmaceutical industry, with a demonstrated track record of successfully advancing novel therapeutics from preclinical/early clinical stages through pivotal development.
- Proven expertise in global regulatory interactions, including successful submissions, negotiations, and approvals with major agencies (FDA, EMA, and others) across early and late-stage programs.
- Prior experience in a CMO, senior VP of Clinical Development, or equivalent medical leadership role in a biotech or pharmaceutical organization, ideally in a fast-paced, innovative environment.
- Hands-on, execution-oriented mindset with a willingness to actively contribute to pipeline advancement, including protocol design, data interpretation, and cross-functional problem-solving.
- Exceptional scientific judgment, strategic thinking, and communication skills
Benefits
- Competitive base salary, performance bonuses, and equity compensation
- Unlimited Paid Time Off (PTO)
- Comprehensive medical, dental, and vision benefits for individuals and families
- 401(k) plan
- Company-paid basic life insurance
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical development strategyregulatory submissionsprotocol designdata interpretationnovel therapeuticsscientific innovationclinical leadershipglobal regulatory interactionsnegotiationsapprovals
Soft Skills
strategic thinkingcommunication skillsscientific judgmentexecution-oriented mindsetcross-functional problem-solvingrelationship managementcollaborationstakeholder engagementleadershipinterpersonal skills
Certifications
MDboard certification