Chief Medical Officer
• Provide leadership and coordination with key research functions to one or more drug development programs.
• Lead development of the Clinical Strategy/Clinical Development Plan and provide medical oversight into protocol development, study conduct and data generation, as well as reporting.
• Lead and coordinate study activities in the program.
• Oversee Phase I-III clinical development programs to ensure that regulatory requirements and quality standards are met. Strive to maintain or exceed compliance obligations for Good Clinical Practices guidelines and standard company operating procedures.
• Be a company representative interacting with external scientific leaders and regulatory authorities for assigned program(s).
• Search and analyze medical literature to write and review abstracts, manuscripts for publications or presentation internally and externally
• Lead/participate in strategic review and input into documents (such as protocols, CRFs, Statistical Analysis Plans, CSRs) to ensure scientific/medical accuracy and consistency with clinical development program.
• Participate in investigator meetings and advisory committee meetings .
• Integrate preclinical information (pharmacology, toxicology, pharmacokinetics) and interpret implications for clinical development as articulated in the Investigator’s Brochure and first-in-human protocol.
• Co-lead product safety review committees as appropriate.
• Provide consultation on medical subjects to investigators and other company personnel, and apply medical knowledge to guide the safe, ethical, and efficient conduct of trials.
• Participate in due diligence efforts for clinical partnerships and/or in-licensing opportunities
• Work with specific clinical and research partners to facilitate seamless execution of collaborative efforts.
• Experience in medical oncology/hematology
• Experience setting up studies in Orphan Drug Designations
• Demonstrated potential or ability to design, initiate, and conduct clinical studies.
• Proven experience as a study director in academia or industry, experience in phase I/II oncology clinical trials required, phase III experience preferred
• Experience and solid understanding of drug developing strategy and process.
• Experience with FDA IND submissions and/or European and/or equivalent
• Proven ability to analyze and interpret efficacy and safety data relating to oncology.
• Able to work across different interfaces (clinical/clinical operations, clinical/project management, clinical/regulatory, clinical/commercial, etc.).
• Demonstrated strong interpersonal skills, ability to influence, and the ability to function in a global team environment.
• Strong and effective communication skills (written and verbal), with excellent medical/scientific writing skills.
• Excellent personal ethical integrity and a commitment to improving the outcomes for patients.
• Experience in with BLA/NDA filings