Location: Remote or CA
Job Summary
The Senior Medical Director – Clinical Development has responsibility for clinical development of targeted radiopharmaceuticals for treatment of solid tumors. Responsibilities may include support for IND preparation, regulatory authority interactions, design and execution of Phase 1 to Phase 3 clinical trials, and medical monitoring. This role provides medical direction and high quality scientific and clinical knowledge to guide the strategy and execution of RayzeBio’s clinical development plan. This role works collaboratively with multi-disciplinary teams responsible for the design, implementation, monitoring, analysis, and reporting of studies conducted within RayzeBio’s portfolio to ensure the program meets the needs of patients and RayzeBio’s business.
Job Responsibilities:
Essential duties and responsibilities include the following. Other duties may be assigned.
- Interact with clinical investigators and thought leaders to design a clinical development plan for nominated drug candidates
- Lead internal project teams, and partner with investigators and CROs to design and implement clinical studies
- Contribute to writing of protocols, investigator brochures, clinical study reports, and review of other clinical trial and regulatory documents
- Conduct investigator meetings and lead site qualification and initiation visits with clinical trial investigators
- Execute and deploy drug development strategic plans, develop contingency plans, provide technical and strategic advice, and meet milestones and budgets
- Translate findings from research and nonclinical studies into clinical development opportunities
- Oversee Data Review and Independent Data Monitoring Committees
- Conduct clinical trials using ethical guidelines relevant to the pharmaceutical industry, and ensure compliance with these external guidelines
- Establish and maintain positive relationships with clinical trial investigators and thought leaders
- Serve as clinical lead for regulatory interactions, including preparation of briefing documents and attendance and presentation at health authority meetings.
- Willing to travel approximately 25% of the time. Evening and weekend work will be involved.
Education and Experience:
- MD or equivalent with at least 5 years of pharmaceutical or biotech experience in oncology solid tumor clinical development.
- Radiopharmaceutical experience is preferred but not required.
- Early development experience and experience in breast cancer clinical development highly desire
Skills and Qualifications:
- Patient-focused, with deep commitment to understanding needs and improving the lives of patients with cancers and a passion for developing novel therapeutics
- Motivated to work in a fast-paced, high accountability, small company environment. A “can do” and collegial professional who leads through influence and interpersonal skills.
- Demonstrated record of accomplishment in a compressed time frame; capable of prioritizing tasks and delivering on deadlines with high performance standards and attention to detail.
- Demonstrated ability to collaborate successfully with multiple functions in a team environment.
- Intellectually curious with courage to challenge and seek new ways to improve work.
- Strong written and oral communication skills, including presentation skills.
- Ability to analyze and interpret data and develop written reports and presentations of those data.
- Strong critical, strategic, and analytical thinking skills.
- Experience in all aspects of protocol conduct, both early and late phase, including protocol writing, start-up, study execution, analysis and reporting.
- Experience in working closely with investigative sites, including principal investigators, sub- investigators, study coordinators and other site personnel involved in clinical trials.
- Skilled in clinical research and understand the process of pharmaceutical product development and approval.
- Able to function in a highly regulated environment and to adhere to all RayzeBio guidelines and standard operating procedures (SOP’s).
- Solid understanding of GCP and ICH guidelines.
Physical Demands:
While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision and distance vision.
Work Environment:
The noise level in the work environment is usually moderate.
The starting compensation for this job is a range from $297,878-$403,011 plus incentive cash and stock opportunities (based on eligibility). The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation will be decided based on demonstrated experience.
Please click here to apply.
