Medical Director

Director / Snr Director, ClinicalDevelopment, Melanoma

TheDirector / Snr Director, Clinical Development will be a MD with aspecialisation in oncology, ideally board-certified, and a deepunderstanding of the solid tumor landscape.

Those who arewell-versed in the current and emerging treatments for melanoma ispreferable and have demonstrated the ability to lead and facilitatelate-stage clinical development strategic planning and beaccountable for the design and medical oversight of thesestudies.

The company is a pioneering,commercial-stage T cell receptor biotechnology company with astrong early pipeline with a fantastic well respected leadershipteam in the Oncology space.

Thiscandidate will be East Coast based, ideally within commutabledistance to the offices, to have some onsitepresence.

SiteLocations : MD andPA.

MD andPA.

KeyResponsibilities :

Lead and shapefuture clinical development strategy and clinical developmentplans, working closely with Development and Discovery Program Leadsand counterparts in Regulatory, Clinical Development, ClinicalOperations, Biostatistics, Clinical Pharmacology, Medical Affairs,Commercial, Non-clinical and Discovery Research for assignedstudies.

• Assure clinical developmentplans are comprehensive, include key decision points, timelyreadouts, and risk mitigation for both near and long-termgoals.
• Design high quality & innovativeclinical trial protocols (including all supporting documents suchas Investigator s Brochure, informed consent, etc) for leadOncology target programs that are aligned with the ClinicalDevelopment Plan and overall productstrategy.
• Establish and maintain strongrelationships with key opinion leaders and partners, to facilitateand support external collaborations.
• Providemedical oversight of clinical studies, implementation,medical / safety monitoring, medical data review, resultsinterpretation, and reporting for assignedstudies.
• Provide strategic clinical leadershipto development teams, including generation of integrated productdevelopment plans that incorporate scientific rationale, regulatoryinput, and advice from medical, patient advocacy groups and payorsappropriate for assigned studies.
• Help buildand manage the relationships with relevant CROs, facilitatethorough understanding of clinical studies, assist in patientrecruitment, and help assure trials are executed on time and withinbudget.
• Contribute to the regulatory strategy,preparation, and review of regulatory submissions, response toIRB / EC questions, and participate in global health agencymeetings.
• Contribute to the development ofpublication plans, present clinical data at key meetings andpublish in high-impact journals.
• Contribute toBusiness Development activities asrequested.

Education &Qualifications :

• MD orMD / PhD with research training orexperience.
• Working knowledge of basic andclinical science.
• Strong understanding ofpharmacokinetics, biomarkers, statistical principles, andregulatory requirements and demonstrated experience integratingthese disciplines in the context of drugdevelopment.
• Broad understanding of oncologydisease area; experience in immuno-oncology and oncology / hematologyfellowship training highly desirable;.
• At least5 years of relevant experience in clinical drug development inpharmaceutical industry (must include experience conducting latephase trials).
• At least 2 years of experienceas a medical monitor in a biotechnology / pharmaceutical company,and / or CRO.

Apply :

For moreinformation, please contact Amy Lloyd at or apply to thepositon.

It is essential candidateshave right to work in the US. Please quote job reference 106196 inall correspondence.