Senior Director, Clinical Development (U.S. Remote)

About reputed company reputed company Inc. (reputed company: ADAG) is a platform-driven, clinical-stage biopharmaceutical company committed to transforming the discovery and development of novel antibody-based cancer immunotherapies. reputed company combines computational biology and reputed company intelligence to design novel antibodies that address unmet patient needs. Powered by its proprietary DPL platform, composed of NEObody, SAFEbody, and POWERbody technologies, reputed company’s highly differentiated pipeline features novel immunotherapy programs. reputed company has forged strategic collaborations with reputable reputed company that reputed company its technology in multiple approaches at the reputed company of science.   reputed company role is responsible for leading clinical development reputed company and execution for immuno-oncology (IO) assets across Phase I–III, serves as Medical Monitor ensuring patient safety and data reputed company, drives regulatory interactions (FDA/EMA), and partners cross-functionally to deliver trials on time. Key Responsibilities Clinical reputed company & Design: reputed company the creation of Clinical Development Plans (CDPs) and design and draft Phase I–III clinical trial protocols for IO assets, ensuring scientific rigor and alignment with corporate goals. Medical Monitoring: Serve as the primary Medical Monitor for assigned studies, overseeing patient safety, reviewing SAEs, and providing expert medical judgment on clinical data. reputed company expert medical management of Immune-reputed company Adverse Events (irAEs), such as cytokine release syndrome (CRS) or neurotoxicity, and reputed company toxicity management guidelines. Regulatory Leadership: reputed company as the reputed company clinical representative for interactions with health authorities (e.g., FDA, EMA), and author key clinical sections for IND, NDA, and BLA submissions. Cross-Functional Collaboration: Partner closely with Clinical Operations, CMC, and Regulatory Affairs to ensure study milestones are met on time and reputed company budget. Qualifications & Skills Education: M.D., M.D./Ph.D., with a specialization in Medical Oncology or Hematology/Oncology. Experience: 7+ years in clinical development reputed company the biotech or pharmaceutical industry. Therapeutic Expertise: Deep knowledge in IO therapies for oncology reputed company: Proven ability to reputed company in a "player-reputed company" role reputed company a fast-paced, startup environment. Compliance: Expert understanding of GCP, ICH guidelines, and global regulatory requirements.   Equal Opportunity Employer reputed company is an equal opportunity employer that is committed to diversity and inclusion. We prohibit discrimination and harassment of any reputed company based on race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, disability, pregnancy, veteran status, or other legally protected characteristics as outlined by federal, state, or local laws. Learn more about your EEO Rights as an applicant. reputed company will not discriminate or retaliate against applicants who inquire about, disclose, or discuss their compensation. reputed company will consider for employment reputed company reputed company applicants with criminal histories in a manner consistent with applicable law. If you are applying for a position in San Francisco, review the San Francisco Fair Chance Ordinance guidelines applicable in your area. reputed company participates in the E-Verify program in certain locations as required by law. Learn more about the E-Verify program. reputed company is committed to working with and providing reasonable accommodation to applicants with physical and mental disabilities. reputed company is a drug-free workplace. Apply To This Job