Medical Director, Melanoma Clinical Lead jobs in United States
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Obsidian Therapeutics · 21 hours ago

Medical Director, Melanoma Clinical Lead

Obsidian Therapeutics is pioneering engineered cell and gene therapies to deliver transformative outcomes for patients. They are seeking a Medical Director to lead the clinical strategy for their melanoma program, ensuring patient safety and data integrity while collaborating with cross-functional teams.

BiotechnologyHealth CarePharmaceutical
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H1B Sponsor Likelynote

Responsibilities

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

Qualification

MD with oncology experienceClinical development experienceImmuno-oncology programsBLA/NDA filing experienceICH-GCP knowledgeFDAEMA regulationsCell therapy backgroundMentoring others

Required

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
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

Preferred

Industry experience preferred: Experience with BLA/NDA filing is preferred
Direct involvement in regulatory interactions or health authority submissions
Cell therapy background highly desired

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

Company

Obsidian Therapeutics

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Obsidian Therapeutics is a developer of a next-generation cell and gene therapies created to extend adoptive immunotherapy.

H1B Sponsorship

Obsidian Therapeutics has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2023 (3)
2022 (2)
2021 (1)

Funding

Current Stage
Growth Stage
Total Funding
$325M
Key Investors
Wellington ManagementThe Column GroupGoogle Ventures
2024-04-03Series C· $160.5M
2021-09-09Series B· $115M
2017-12-06Series A· $49.5M

Leadership Team

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Madan Jagasia
Chief Executive Officer
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Kirsten Kester
Senior Vice President, Business Development
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Company data provided by crunchbase