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RayzeBio

Senior Medical Director Clinical Development - Prostate Cancer

RemoteUnited States only
Published
Experience
Lead
Employment
Full-time
Company size
Startup
$306.8k–$371.8k/yr
Check eligibility

Open to US only. Set where you work from to check your eligibility.

No BS summary

Senior medical/clinical development leader with an MD or equivalent, oncology solid tumor background, and 10+ years in pharma/biotech/academic clinical development. Must have drug development experience in prostate cancer and be able to lead IND-to-Phase 3 strategy, regulatory interactions, clinical teams, and trials. Remote US role with about 30% travel.

Required skills

AIGCPICH guidelines

What you'll do

  • Interact with clinical investigators and thought leaders to design a clinical development plan for nominated drug candidates
  • Lead internal study teams, and partner with investigators and CROs to design and implement clinical studies
  • Work closely with GPLs to ensure development and commercial optimization of Rayze Bio assets
  • 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
  • As needed serve as clinical lead for regulatory interactions, including preparation of briefing documents and attendance and presentation at health authority meetings
  • Oversee regulatory submissions for assets in prostate cancer indications
  • Lead cross-functional study teams and supervise and mentor clinical scientists and medical directors in executing the programs for prostate cancers
  • Recruit and build and manage team of medical directors and clinical scientists as needed based on programmatic needs
  • Leverages AI to drive program, portfolio, or functional performance through prioritization and scaled adoption
  • Willing to travel approximately 30% of the time

What they require

  • MD or equivalent ideally with sub-specialty training in oncology and at least 10 years of pharmaceutical/biotech/academic experience in oncology solid tumor clinical development is required
  • Drug development experience in prostate cancer is required
  • Preferred: radiopharmaceutical experience is preferred but not required
  • 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
  • Demonstrated leadership of clinical and cross-functional teams in a biotech environment
  • Demonstrated ability to manage multiple stakeholder engagements across development and commercial organizations
  • Intellectually curious with courage to challenge and seek new ways to improve work
  • Strong written and oral communication skills, including presentation skills
  • Strong critical, strategic, and analytical thinking skills
  • Experience in NDA/MAA preparation and submission and in complex health authority interactions globally
  • 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

Benefits

  • Additional incentive cash and stock opportunities (based on eligibility) may be available
  • Health Coverage: Medical, pharmacy, dental, and vision care
  • Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP)
  • Financial Well-being and Protection: 401(k) plan
  • Short- and long-term disability
  • Life insurance
  • Accident insurance
  • Supplemental health insurance
  • Business travel protection
  • Personal liability protection
  • Identity theft benefit
  • Legal support
  • Survivor support
  • Paid Time Off
  • US Exempt Employees: flexible time off (unlimited, with manager approval)
  • 11 paid national holidays
  • Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval
  • 3 optional holidays
  • Based on eligibility, additional time off for employees may include unlimited paid sick time
  • Up to 2 paid volunteer days per year
  • Summer hours flexibility
  • Leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs
  • Annual Global Shutdown between Christmas and New Years Day

RayzeBio is a wholly-owned subsidiary of Bristol Myers Squibb developing transformative radiopharmaceutical therapies for patients living with cancer.

🇺🇸 United StatesBiotechStartup
$306.8k–$371.8k/yr