Medical Director, Melanoma Clinical Lead

Job not on LinkedIn

November 24

🍂 Massachusetts – Remote

Although this job is listed in Massachusetts, this company may be open to hiring remote in other states.

💵 $260.5k - $318k / year

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

🦅 H1B Visa Sponsor

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Obsidian Therapeutics

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Biotechnology • Pharmaceuticals

Obsidian Therapeutics is a leading biotechnology company pioneering in the field of precision cell and gene therapy. Utilizing its proprietary cytoDRiVE® platform, the company engineers precision medicines by harnessing the power of regulated therapeutic proteins. Obsidian's innovative programs, including the OBX-115, target advanced melanoma and have been recognized by the FDA with both Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations. Their pipeline of investigational therapies is designed to offer new hope for patients with unmet medical needs.

51 - 200 employees

🧬 Biotechnology

💊 Pharmaceuticals

💰 Series C on 2024-04

📋 Description

• Serve as the medical monitor for Obsidian’s lead program. • Function as a key contributor to the clinical strategy as part of an integrated drug development team and provide scientific input to protocol development. • Develop and cultivate relationships with external partners such as clinical investigators, clinicians, scientists, and vendors. • Lead advisory boards, consultant meetings, and investigator meetings including preparation and delivery of presentations. • Understand competitive landscape and provide insights on strategic developments pathways. • Liaise effectively with sites, CROs, investigators, study sites, advisors, and regulatory agencies. • Provide medical, disease-specific, and development perspectives into specific research programs or broader research initiatives. • Rapidly integrate new insights derived from ongoing clinical trials, translational science, or basic science. • Create and deliver compelling data presentations for internal and external meetings. • Author key documents, including clinical protocols, Investigator’s Brochures, IND summary documents, CTAs for initiation of US and ex-US studies, and responses to questions from regulatory authorities, IRBs, and ethics committees. • Prepare data and contribute to scientific publications including posters, abstracts, and manuscripts. • Oversee data management to ensure completeness and accuracy of the clinical data. • Support pharmacovigilance activities including review of safety reports, safety follow-ups, and annual summary documents such as DSUR and IB. • Prepare medical answers to questions from Health Authorities, IRB/Ethics Committees, investigators, and experts involved in the study/project. • Update of study documents, eCRF adequacy with protocols/protocol amendments, and help in rationalizing and documenting the data collection needs quantitatively and qualitatively, decreasing the complexity. • Collaborate with the clinical team on the review, analysis, and interpretation of study results including exploratory endpoints, and ensure appropriate data review and accurate data reporting. • Develop study specific training material and participate in the Investigators, Study Team, and Monitoring Team training on medical information.

🎯 Requirements

• MD with 5+ years of experience in oncology. • 3–5+ years of experience in clinical development supporting Phase I-III oncology trials, especially immuno-oncology programs. • Industry experience preferred: Experience with BLA/NDA filing is preferred. Direct involvement in regulatory interactions or health authority submissions • Academic only experience considered: Academic accomplishment as a clinical investigator conducting trials in oncology. Cell therapy background highly desired. • Strong knowledge of ICH-GCP, FDA, and EMA regulatory requirements. • Track record of mentoring others. • May consider MD with board certified fellowship in Oncology (no industry experience) if you have a strong track record of academic achievements in oncology trials, and cell therapy experience.

🏖️ Benefits

• Comprehensive medical, dental, and vision coverage • Company contributions to health savings and retirement accounts • Ample paid time off • Access to wellness programs • Rich career growth opportunities