Location: Remote and San Diego, CA
Job Summary
The Senior Director – Clinical Pharmacology will be a key member of the development team, developing clinical pharmacology strategy, leading the design, execution, interpretation and reporting of clinical pharmacology data, and serve as clinical pharmacology lead on studies and project teams. The role will support projects at various stages of development, playing an active role in our drug discovery and development efforts to advance RayzeBio’s radiopharmaceutical pipeline.
Job Responsibilities:
Essential duties and responsibilities include the following. Other duties may be assigned.
- Develop clinical pharmacology strategy and related clinical development plan consistent with the development strategy, program goals, and the US/international regulatory guidance for radiopharmaceuticals.
- Collaborate with DMPK, clinical development, and CMC teams to define clinical pharmacology data needed to support NDA and drug label.
- Determine scope, design, plan, analyze and interpret pharmacokinetic and pharmacodynamics (PK/PD) in company-sponsored studies, including development of appropriate population PK models, and PK/PD analysis required from a development and regulatory perspective to take a project from concept stage to commercialization.
- Provide clinical pharmacology expertise to the project team and closely collaborate with Clinical Operations, Clinical Development, Biometrics, and Regulatory Affairs.
- Contribute to the design and execution of Phase 1 clinical pharmacology (eg, drug-drug interactions, relative bioavailability/bioequivalence, special populations, and thorough QT, etc.) and dosimetry studies.
- Contribute to writing of protocols, investigator brochures, clinical study reports, and review of other clinical trial documents.
- Plan, prepare, and review clinical pharmacology section of the regulatory documents (IND, IMPD, IB, NDA CTD, etc.), participate in drafting publications and making scientific presentations consistent with development strategies.
- Serve as the primary Clinical Pharmacology Lead and effectively participate in cross functional teams to ensure integration of clinical pharmacology principles into project plans and study design.
- Represent clinical pharmacology at regulatory meetings and advisory hearings with global health authorities.
- Other duties as assigned.
- Willing to travel up to approximately 10% of the time (if not based in San Diego area).
Education and Experience:
- PhD, MD or PharmD with at least 8-10 years of pharmaceutical or biotech experience in clinical pharmacology and oncology drug development.
- Experience with early and late-stage clinical development, IND, and filing dossier.
- Radiopharmaceutical experience is preferred but not required.
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.
- Strong background and expertise in Clinical Pharmacology, PK and PK/PD demonstrated by major Regulatory submission experience and/or scientific publications.
- Proven ability to manage strategic, scientific and operational aspects of development projects from a Clinical Pharmacology perspective.
- 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 $234,726-$317,571 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.
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