Senior Medical Director, Clinical Development

MD or MD/PhD degree required. 7-10 years of experience in the biopharmaceutical industry with experience in oncology drug development and design/conduct of clinical trials. Training and experience in oncology; pediatric oncology and/or neuro-oncology experience is preferred. Board certified or eligible in oncology (and/or hematology). Knowledge of ICH and Good Clinical Practice. Familiarity with global and regional regulations. Experience in the assessment of adverse events and safety of patients participating in oncology clinical trials. Skilled in modern oncology protocol design, data interpretation, biostatistics, and medical monitoring. Strong interpersonal skills. Ability to function in a team environment. Ability to lead by example, build interdependent partnerships, and participate in a culture of collaboration and teamwork. Able to prioritize and manage several projects simultaneously. Ability to work in a fast-paced and ever-changing environment. Proven track record of working effectively in diverse teams involving multi-functional disciplines. Proven ability to develop internal relationships in a matrix environment, whether in person or remotely, as well as external relationships with Key Opinion Leaders and industry experts. Outstanding verbal, written, and presentation skills. A desire to be part of a highly innovative company. Exceptionally organized with keen attention to detail.

Provide medical and scientific expertise and oversight for clinical trials. Serve as the primary accountable person for the design, execution, monitoring, delivery, and reporting of clinical studies. Act as the Medical Monitor for clinical trials, ensuring patient safety. Author/review safety and efficacy summaries, clinical overviews, investigator brochures, risk management plans, periodic safety updates, and clinical sections of product labels. Present study results to internal and external committees or advisory boards. Prepare data for presentation at international scientific meetings and publications. Collaborate with the DAY301 Product Team Lead to advance the PTK7-directed antibody-drug conjugate, DAY301. Lead the Clinical Development Sub-Team within the Product Team. Design clinical studies to meet stated objectives. Drive and advance clinical and integrated development plans from FIH trial to regulatory approval. Review and amend clinical trial protocols. Review and approve informed consents. Provide medical input into the assessment of investigational site capabilities. Participate in the review and approval process for data capture and review. Organize expert panels, consultants, or advisor board meetings. Provide managerial oversight to a team consisting of Medical Directors, Clinical Scientists, and/or Fellows. Build clinical development team according to needs of the program. Provide protocol training for investigators. Handle issue resolution and audit responses. Ensure readiness for inspections. Develop and/or adhere to safety review plans. Perform and document regular review of individual subject safety data and cumulative safety data. Review individual subject data and determine follow-up needs. Perform reviews of data generated by statistical analyses. Perform reviews and procedures required for database finalization. Lead the authoring of clinical study reports. Lead the authoring of clinical sections of regulatory documents. Answer and resolve medical and safety questions from sites. Support regulatory interactions and provide responses to regulatory inspection observations. Support RA updates and submissions for IND documents. Assist with clinical sections of regulatory filings. Assist in the preparation and delivery of clinical study reports and results for internal and external purposes.