Associate Director, Clinical Development

Ascentage Pharma - United States

Hiring: Associate Director, Clinical Development Company: Ascentage Pharma Location: United States Job Posted Time: 2026-09-16 15:46:21 Employment Type: Hybrid Target Skills & Keywords : GCP About the job Experience: •2-4 years of clinical research experience in the pharmaceutical or biotechnology industry, academia, or equivalent, specifically within oncology drug development. •4 years of clinical research experience in the pharmaceutical or biotechnology industry, academia, or equivalent, specifically within oncology drug development. Required Skills: •Contribute to the development and execution of clinical development plans and study strategies under the supervision of senior clinical leadership. •Support indication‑specific strategy through literature reviews, data analysis, and scientific input into development decisions. •Assist in drafting and reviewing clinical trial documents, including protocol concepts, study synopses, protocols, amendments, and operational documents. •Collaborate cross‑functionally to ensure scientific and operational alignment. •Participate in medical monitoring activities, including patient eligibility reviews, safety data assessments, and ongoing study data evaluation in collaboration with senior medical monitors and pharmacovigilance. •Contribute to review of study integrity, safety summaries, and internal communication of emerging data. •Support preparation of clinical content for regulatory submissions (e.g., INDs, NDAs, Investigator Brochures, Clinical Study Reports). •Participate in regulatory meetings as appropriate and ensure adherence to Good Clinical Practice (GCP) and internal quality standards. Qualifications: •Medical Doctor (M.D.), Doctor of Osteopathy (D.O.), or internationally recognized equivalent degree, with completion of an accredited clinical residency program. •Board certification or eligibility in Medical Oncology or Hematology/Oncology is strongly preferred. •Exposure to multinational Phase I–III oncology trials. •Prior involvement in medical monitoring or investigator roles. •Interaction with regulatory agencies (e.g., FDA) Compensation: •Flexible work environment (work from home / hybrid options) •Competitive benefits and rewards package Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!