Senior Medical Director, Clinical Development

remixtherapeutics

Watertown13h ago

Seniority: Lead

About the role

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.  Position Summary: This role is for a clinician ready to take on real medical ownership and help shape how REM-422 and future programs are developed. Reporting directly to the Chief Medical Officer at our Watertown, MA headquarters, you will work alongside senior leadership at a pivotal moment in the company's clinical trajectory, with direct visibility into how key development decisions get made. You will be a core contributor across a small, high-caliber cross-functional team where your judgment matters from day one.  We are seeking someone with 5+ years of industry experience in oncology drug development and looking to grow as Remix scales.  Key Responsibilities: Clinical Trial Execution & Medical Monitoring  <ul> <li data-leveltext="" data-font="Symbol" data-listid="7" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1">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 </li> <li data-leveltext="" data-font="Symbol" data-listid="7" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1">Review and assess SAEs, including narrative writing, causality assessment, and reconciliation with the safety database </li> <li data-leveltext="" data-font="Symbol" data-listid="7" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1">Respond to site medical queries, review eligibility exceptions, and support investigators on protocol requirements and deviation management </li> <li data-leveltext="" data-font="Symbol" data-listid="7" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1">Author and revise clinical documents including protocol synopses, IB sections, ICFs, and CSR narratives </li> <li data-leveltext="" data-font="Symbol" data-listid="7" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1">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 </li> </ul> Regulatory & Cross-Functional Collaboration  <ul> <li data-leveltext="" data-font="Symbol" data-listid="8" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1">Support FDA and other agency meeting preparation; contribute medical sections to regulatory filings and briefing documents </li> <li data-leveltext="" data-font="Symbol" data-listid="8" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1">Collaborate with Clinical Operations on site selection, patient recruitment strategies, and trial execution </li> <li data-leveltext="" data-font="Symbol" data-listid="8" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1">Work closely with Pharmacovigilance, Biostatistics, and Regulatory Affairs to ensure aligned cross-functional execution </li> <li data-leveltext="" data-font="Symbol" data-listid="8" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1">Partner with KOLs, CROs, and investigators; provide medical input on vendor deliverables, data collection tools, and medical coding </li> </ul> Qualifications: Required  <ul> <li data-leveltext="" data-font="Symbol" data-listid="3" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1">MD or equivalent medical degree </li> <li data-leveltext="" data-font="Symbol" data-listid="3" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1">5+ years of oncology clinical development experience within a biotech or pharmaceutical organization </li> <li data-leveltext="" data-font="Symbol" data-listid="3" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1">Hands-on experience as a medical monitor or clinical study physician, including SAE review and site oversight </li> <li data-leveltext="" data-font="Symbol" data-listid="3" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1">Familiarity with early-phase (Phase 1/1b) oncology trial design and execution </li> <li data-leveltext="" data-font="Symbol" data-listid="3" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1">Working knowledge of ICH/GCP guidelines and FDA regulatory requirements </li> <li data-leveltext="" data-font="Symbol" data-listid="3" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1">Strong scientific acumen with ability to engage deeply with translational data and biomarker-driven programs </li> <li data-leveltext="" data-font="Symbol" data-listid="3" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1">Excellent written and verbal communication; able to author clinical documents and synthesize complex data for varied audiences </li> </ul> Preferred  <ul> <li data-leveltext="" data-font="Symbol" data-listid="4" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1">Experience with rare solid tumors, ACC, or head and neck oncology </li> <li data-leveltext="" data-font="Symbol" data-listid="4" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1">Exposure to hematologic malignancies (AML, MDS) </li> <li data-leveltext="" data-font="Symbol" data-listid="4" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1">Experience on biomarker-heavy or genomically-selected programs </li> <li data-leveltext="" data-font="Symbol" data-listid="4" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"multilevel"}" data-aria-posinset="1" data-aria-level="1">Familiarity with RNA or spliceosome biology </li> </ul> Salary Range: $230,000-$330,000 USD<span class="EOP Selected SCXW232710140 BCX0" data-ccp-props="{"134233117":false,"134233118":false,"201341983":0,"335551550":1,"335551620":1,"335559685":0,"335559737":0,"335559738":60,"335559739":60,"335559740":259}">  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.

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