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ARTBIO · 5 months ago

Senior Medical Director, Clinical Development

Cambridge, MA

Full-time

Onsite

Mid, Senior Level

4+ years exp

ARTBIO is a global biotech company redefining cancer care through innovative radioligand therapies. The Senior Medical Director will provide clinical leadership for Phase 1-3 studies, collaborate with various teams, and ensure the successful execution of clinical goals and objectives.

BiotechnologyHealth CareHospitalMedicalMedical DevicePharmaceutical

Responsibilities

Primary responsibility for clinical and safety oversight of company sponsored Phase 0-3 clinical trials

Key clinical expert for study protocols and clinical development plans for each molecule in clinical development

Key clinical stakeholder to answer health authority and IRB/ethics committee questions for the molecules in clinical development

Works with medical writing and regulatory, and clinical operations to author protocols, investigator brochures, annual reports, clinical study reports and DSURs

Leads and when necessary supports clinical study start-up, data base locks, and study closeouts

Primary medical reviewer for ongoing and active company-sponsored studies

Collaborate with cross functional partners to execute on clinical goals and objectives, ensuring timely achievement of milestones

Lead clinical study teams, ensuring effective communication and coordination in partnership with the clinical operations team

Provide strategic input to potential partnership and licensing opportunities

Maintain the highest standards of clinical study and operational integrity

Qualification

Oncology expertiseClinical research experienceClinical leadershipMDEquivalent degreeStrategic inputCollaboration skillsCommunication skillsTeam leadership

Required

MD or equivalent degree with postdoctoral training in an oncology specialty

Minimum of 4 years of relevant clinical research experience for therapeutic molecules in a relevant academic setting or in the biotech/pharma industry