Associate Director Pharm/Tox

San Diego, CA

  • We are seeking a creative and highly motivated scientist with a strong research background and proven ability to contribute to the understanding of the pharmacologic / toxicologic mechanism(s) of drug-induced responses.
  • The best candidate for this position will work collaboratively with other functional areas within the Samumed R&D organization (Discovery, DMPK, Medicinal Chemistry) to design and implement relevant screening, investigative studies, and assays to characterize and mitigate key safety liabilities associated with Samumed novel anti-cancer target class.
  • In addition, the candidate will contribute to developing strategies and executing nonclinical activities to support the progression of anti-cancer molecules from early Discovery to FIH clinical trials.
  • This position will provide the opportunity for the candidate to contribute to regulatory filings (INDs, briefing books, or NDAs) in collaboration with various corporate functions including Regulatory Affairs.
  • This is a full-time position in the company’s San Diego headquarters.

Specific Responsibilities

  • Ability to evaluate complex biological pathways, characterize the mechanisms of key safety liabilities, and develop mitigation strategies
  • Ability to set up nonclinical strategies to support transition of molecules from early Discovery to candidate selection and FIP clinical trials
  • Will serve as a toxicology project representative in early and late Discovery and Development teams
  • Will serve as, or work with study monitors to oversee the design, interpretation and reporting of exploratory and GLP-compliant studies that are outsourced
  • Must be able to effectively contextualize study plans and results for team decision making in support of asset characterization
  • Assist with the selection of appropriate CRO/test facilities, perform site audits/visits, develop study protocols and budgets, coordinate multi-site activities, analyze, and interpret data, and review and edit study reports.
  • Prepare nonclinical documents in support of regulatory filings (INDs, NDAs, briefing books etc.)

Requirements

  • PhD in Toxicology or other relevant scientific disciplines with 8+, or master’s degree with 13+ years of experience 
  • Exceptional in mechanistic and investigative toxicology and pharmacology
  • Experience in design, direct, and monitor of toxicology studies
  • Experience in multiple therapeutic areas with experience in oncology preferred
  • Prior experience in contributing to the preparation of nonclinical regulatory documents
  • Excellent oral and written communication skills
  • Must be a team-player, dependable and flexible in adapting to change in multidisciplinary, fast-paced R&D organization

Please submit your resume or additional inquiries to apply@samumed.com. Please include the complete title of the position for which you are applying in the subject line of your email. Emails that do not include this information will be disregarded. NO PHONE CALLS PLEASE.