Senior Director - Clinical Sciences

2 days ago

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Affini-T Therapeutics

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Affinittx.com

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💰 $175M Venture Round on 2022-03

Description

• Manage and execute clinical research activities for multiple trials • Serve as a Clinical Trial Lead or Co-Lead • Represent Clinical Science across functional activities and oversee clinical research activities internally and with CROs • Support authoring of the clinical development plan (CDP) and target product profile (TPP) • Lead implementation of assigned clinical development plans • Provide scientific and clinical leadership to support all activities to advance the assigned plans • Collaborate with medical directors/Clinical Development physicians, clinical operations, clinical data science, and other groups to conduct clinical review of study data

Requirements

• Advanced clinical/scientific degree (e.g., PharmD, PhD, MSN, MPH) • Minimum 5 years of global experience in clinical drug development • Sound knowledge of medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE and other relevant guidelines and regulations • Experience leading clinical research activities and overseeing CROs • Proficient project management skills • Oncology experience preferred • Cell therapy experience preferred