Medical Director, Melanoma Clinical Lead

Obsidian Therapeutics•Cambridge, MA

27d

About The Position

We're looking for a motivated, patient-centric, and highly collaborative MD to serve as the Medical Lead for our OBX-115 study in Melanoma. This is a unique opportunity to expand the reach of TIL therapy and deliver transformative outcomes for patients suffering from solid tumor malignancies. Reporting to the VP of Clinical Science, you will be a key member of the Clinical Development team. As the clinical expert and medical monitor you will lead the ongoing clinical trials in melanoma and support other oncology indications by providing medical oversight for patient safety, data integrity, and protocol adherence throughout all phases of clinical development. You'll work closely with the Clinical Scientist in the program and other cross-functional teams including clinical operations, data management, pharmacovigilance, and biostatistics to ensure high-quality execution of clinical programs aligned with regulatory and scientific standards. As a key contributor in a well-funded clinical company with blue chip investors, field-leading advisors, best-in-class partners, and an experienced team, you'll help us build a dynamic, innovative, passionate, collaborative, and successful organization focused on delivering transformative therapies in areas of greatest clinical need.

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.

Nice To Haves

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.

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.