Senior Medical Director, Clinical Development

Remixtherapeutics; Watertown (MA); On-site; USD 230,000 - 330,000; Full time

Job summary

Remixtherapeutics in Watertown, Massachusetts, is seeking a physician to lead clinical studies for REM-422, focusing on adenoid cystic carcinoma. Responsibilities include overseeing patient safety, authoring clinical documents, and collaborating across functions.

The ideal candidate will have an MD and 5+ years of oncology clinical development experience. This role offers a competitive salary ranging from $230,000 to $330,000, alongside benefits tailored to the candidate's qualifications.

Qualifications

• 5+ years of oncology clinical development experience within a biotech or pharmaceutical organization.
• Hands-on experience as a medical monitor or clinical study physician.
• Familiarity with early-phase oncology trial design and execution.

Responsibilities

• Serve as physician lead for REM-422 clinical studies.
• Review and assess serious adverse events.
• Collaborate with Clinical Operations on trial execution.

Skills

Oncology clinical development

Medical monitoring

Clinical trial design

ICH/GCP guidelines

Scientific acumen

Communication skills

Education

MD or equivalent medical degree

Job description

Position Summary

Patients with adenoid cystic carcinoma (ACC) have waited decades for a treatment option. At Remix Therapeutics, we intend to change that. We are a clinical-stage biopharmaceutical company that has pioneered a new class of small molecule medicines targeting the RNA splicing machinery—correcting the disease-causing errors that drive ACC and other serious conditions at their source. REM-422 is our lead program, currently in clinical evaluation for ACC and AML/HR-MDS, and it is at a critical inflection point. Remix is building the team to bring this novel molecule forward for patients.

Key Responsibilities

Clinical Trial Execution & Medical Monitoring

• 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 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, IB sections, ICFs, and CSR narratives
• Interpret evolving clinical data—including safety trends, PK/PD signals, and emerging biomarker findings—and bring forward clear recommendations to the CMO and senior clinical team

Regulatory & Cross-Functional Collaboration

• Support FDA and other agency meeting preparation; contribute medical sections to regulatory filings and briefing documents
• Collaborate with Clinical Operations on site selection, patient recruitment strategies, and trial execution
• Work closely with Pharmacovigilance, Biostatistics, and Regulatory Affairs to ensure aligned cross-functional execution
• Partner with KOLs, CROs, and investigators; provide medical input on vendor deliverables, data collection tools, and medical coding

Qualifications

Required

• 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, ACC, or head and neck oncology
• Exposure to hematologic malignancies (AML, MDS)
• Experience on biomarker‑heavy or genomically‑selected programs
• Familiarity with RNA or spliceosome biology

Salary Range

$230,000‑330,000 USD

This range reflects the expected base salary for this position, plus bonus, equity, and benefits as applicable. Actual salaries may vary based on factors, such as skill, experience, and qualification for the role.