Associate Director, Clinical Scientist

Black Diamond Therapeutics is a next-wave cancer precision medicine company. Black Diamond pioneered the development of selective medicines for patients with genetically defined cancers driven by oncogenes activated by allosteric mutations. Using its mutation, allostery and pharmacology (MAP) computational and discovery platform, Black Diamond is uncovering new ways to functionally assess the mutational landscape of individual oncogenes – to discover and validate new targets and develop novel approaches to creating highly selective therapeutics.

• Ability to interact effectively within a cross functional team
• Advanced degree such as a PhD or PharmD or equivalent combination of relevant education and experience may also be considered
• Comprehensive knowledge of oncology clinical trial implementation and drug development process
• Monitors real time study data to ensure study integrity and clinical trial data are collected in GCP compliance with the protocols and eCRF Completion Guidelines; interacts with internal experts to resolve any study issues
• Serve as Clinical Science representative and provide relevant expertise for new process development initiatives and working groups as needed
• Serves as program team resource identifies issues and inefficiencies, recommends solutions to challenges, and provides further guidance as needed
• Follow developments of competitive programs and/or trials in order to provide critical thinking on potential impacts program goals and strategy
• Perform clinical review of data listings and essential study data within generated statistical reports (eg, SAS outputs) and other available data surveillance tools (eg, JReview/Rave, Spotfire) and partner with Medical Review and Data Management in generating relevant queries
• Demonstrated understanding of the clinical drug development process to execute drug development strategic plans and meet milestones
• Other duties as required or directed by the Manager or Functional Management
• 6+ years’ experience in biotech/pharmaceutical industry
• The ideal candidate will work collaboratively with a cross functional team ensuring that clinical and scientific issues are appropriately considered in the development and execution of individual clinical studies and overall development plans
• Champions the analysis and synthesis of complex information to assess issues relating to protocol conduct and/or individual subject safety
• Contributes to project level documents including Investigator’s Brochure, DSUR, Briefing Books, clinical sections of study-related regulatory submissions and responses to regulatory queries.
• Ensuring adherence to BDTX’s Standard Operation Procedures and values, and maintaining the highest level of ethical behavior by leading by example
• Proactively identifying challenges/problems and proposing solutions with a strong sense of urgency
• Assists in the creation and continuous improvement of Clinical Development work processes
• Strong knowledge of Good Clinical Practices (GCP), FDA, and EMEA/CHMP regulations and guidelines; familiarity with other international regulatory requirements is a plus
• Support translational and biomarker strategies and delivering biomarker data for ongoing clinical programs
• Collaborating with Clinical Operations and other team members in the development of agendas, training materials and presentation for site visits, investigator meetings and other study related activities
• Maintaining clinical and technical expertise in the therapeutic area of oncology
• Organizing and performing the study level and individual subject level analysis of the clinical trial data and compiles periodic clinical data summaries including safety, efficacy, pharmacokinetic and biomarker data to gain insights and develop strategies for the clinical study report (CSR) writing
• Participate in CRF design and review for CRF design and instructions for unique CRFs as well as data quality plan and study data review plan.
• In conjunction with Medical Director, support the creation of and/or review of clinical slides for internal and external meetings (i.e Assist in the collection and compilation of data and coordinate review/submission to scientific meetings for abstracts/posters and other publicly distributed materials
• Develop effective working relationship with cross-functional teams to optimize scientific quality/innovation of clinical study design, execution, reporting and publication
• Involved in high level data cleaning activities and clinical judgment and analysis of complex data for regulatory submissions, publications and design of studies and programs