Job Type
Full-time
Description
Position Overview:We are seeking a Senior/Executive Medical Director to lead early-phase oncology clinical development. This role serves as the primary medical lead for one or more investigational compounds from first-in-human through proof of concept, driving clinical strategy, ensuring patient safety, and advancing programs toward key milestones.
You will work cross-functionally with translational science, biomarkers, regulatory, and portfolio teams to define and execute development plans. The ideal candidate is a physician-scientist with deep oncology expertise, hands-on early-phase trial experience (including CRO oversight), and a strong commitment to delivering innovative therapies to patients. Regulatory and global experience are a plus.
Key Responsibilities:Clinical Strategy- Serve as the Medical Lead for early-phase oncology programs (FIH through proof of concept).
- Develop Clinical Development Plans, including indication strategy, study design, and decision criteria.
- Define dose-escalation approaches, expansion cohorts, and patient selection in partnership with translational and biomarker teams.
- Drive data-informed decisions through safety reviews, data analyses, and portfolio discussions.
Study Design & Execution- Author and oversee key clinical documents (protocols, IBs, ICFs, CSRs).
- Provide medical oversight for trial execution, including safety monitoring and investigator engagement.
- Lead medical monitoring activities (AE review, signal detection, dose management).
- Participate in or chair SRCs, DMCs/IDMCs, and internal governance meetings.
- Partner with biostatistics on endpoints and analysis plans aligned with regulatory expectations.
Regulatory & Scientific Engagement- Contribute to regulatory submissions (INDs, amendments, briefing documents, responses).
- Support regulatory interactions as a medical expert (FDA, EMA, global agencies).
- Build relationships with KOLs, academic institutions, and patient advocacy groups.
- Lead publications and present data internally, at conferences, and to external stakeholders.
Cross-Functional Leadership- Serve as a core Program Team member, providing medical leadership across functions.
- Mentor junior clinical staff and contribute to team development.
- Support business development activities, including scientific due diligence and partnerships.
Qualifications:Required- MD, MD/PhD, or DO with board certification/eligibility in Oncology, Hematology/Oncology, or related field.
- 10+ years of industry experience, including 5+ years in biotech drug development.
- Proven leadership in Phase I/II oncology trials, including FIH studies.
- Strong expertise in oncology biology, biomarkers, and precision medicine.
- Experience with regulatory submissions and health authority interactions.
- Excellent communication skills with the ability to translate complex data clearly.
Preferred- Experience with accelerated regulatory pathways (e.g., Breakthrough Therapy, Fast Track, RMAT).
- Global/ex-US clinical development experience.
We welcome applications from skilled individuals whose qualifications may not fit the criteria outlined above.
Base Salary: $300-$325k
