Senior Medical Director, Clinical Development
Remix Therapeutics · Watertown, MA · 3 wk ago
Healthcare$230k–$330k/yrFull-time
Key Responsibilities
- Serve as physician lead and medical monitor for REM-422 clinical studies, with direct accountability for patient safety, protocol adherence, and scientific and ethical rigor
- Review and assess Serious Adverse Events (SAEs), including narrative writing, causality assessment, and reconciliation with the safety database
- Respond to site medical queries, review eligibility exceptions, and support investigators on protocol requirements and deviation management
- Author and revise clinical documents including protocol synopses, Investigational Brochure (IB) sections, Informed Consent Forms (ICFs), and Case Report Form (CRF) narratives
- Interpret evolving clinical data — including safety trends, pharmacokinetic/pharmacodynamic (PK/PD) signals, and emerging biomarker findings — and bring forward clear recommendations to the Chief Medical Officer and senior clinical team
Qualifications
- MD or equivalent medical degree
- 5+ years of oncology clinical development experience within a biotech or pharmaceutical organization
- Hands-on experience as a medical monitor or clinical study physician, including SAE review and site oversight
- Familiarity with early-phase (Phase 1/1b) oncology trial design and execution
- Working knowledge of ICH/GCP guidelines and FDA regulatory requirements
- Strong scientific acumen with ability to engage deeply with translational data and biomarker-driven programs
- Excellent written and verbal communication; able to author clinical documents and synthesize complex data for varied audiences
Preferred
- Experience with rare solid tumors, adenoid cystic carcinoma (ACC), or head and neck oncology
- Exposure to hematologic malignancies (acute myeloid leukemia, myelodysplastic syndromes)
- Experience on biomarker-heavy or genomically-selected programs
- Familiarity with RNA or spliceosome biology
Pay
Salary Range: $230,000-$330,000 USD