Director/Sr Director, Clinical Sciences

20 hours ago

Los Angeles CA United States Poseida Therapeutics Full time

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Description
** This has been designated as a remote based role. We can consider remote based employees in the below states. Please note that regardless of location, this position must be able to accommodate working Pacific business hours.CaliforniaArizonaFloridaGeorgiaIdahoMassachusettsMissouriNevadaNew JerseyNorth CarolinaPennsylvania TexasVirginiaWashington
Your ImpactIn this role you will provide leadership and oversight of our clinical studies including planning, execution, completion, and reporting of clinical trials that drive Poseida's mission to cure patients of cancer.
Position SummaryPoseida Therapeutics is seeking a talented Director/Sr Director Clinical Research to join our Clinical Development team. This role will support, guide and implement clinical development trials, strategy and plans. As well as be responsible for the timely execution of First in Human programs through proof of concept and delivery on clinical study designs, high quality trial execution, and preparation of clinical protocols from IND to late phase clinical trials working closely with the ED of Clinical Sciences.
Responsibilities These may include but are not limited to:
  • Provide leadership, oversight, and management of clinical studies including planning, execution, completion, and reporting of clinical trials.
  • Oversee the review and analysis of clinical data and the generation of study reports, publications, and regulatory documents.
  • Oversee and conducts data review, analysis, and interpretation of clinical trials data
  • Drafts and follows safety and data review plans to perform and document regular review of patient safety data and perform review of cumulative safety data
  • Draft clinical and safety sections of critical documents, such as protocols, ICF, IB and health authority briefing books.
  • Provide frequent updates on the clinical programs to the internal stakeholders.
  • Work closely with new team members to train them on disease areas and clinical trials to bring them up to speed.
  • Prepare and conduct presentations regarding strategy and/or data and supports and assist in the development of publications, abstracts and presentations
  • Partners with translational science and clinical operations as needed to ensure compliance with GCP and quality execution of plans that involve patient samples and analysis
  • Develop and maintain professional relationships with external stakeholders
  • Work closely with the CRO and cross functional teams.
    Requirements
    Requirements, Knowledge, Skills, and Abilities
    • Director: PhD/PharmD and 9+ years; or Masters/MSN or Bachelors/BSN with 12+ years of experience in clinical research/development in leadership roles.
    • Senior Director: PhD/PharmD and 11+ years, or Masters/MSN or Bachelors/BSN with 15+ years of experience in clinical research/development in leadership roles.
    • Experience in oncology drug development; early development experience in hematological cancers and autoimmune strongly preferred.
    • Experience with cell therapy trials in cancer is required.
    • Experience in cell therapy in autoimmune diseases is highly desired.
    • Experience with autologous as well as allogeneic trials are highly desired.
    • Proven scientific writing skills and superior communication skills.
    • Experience with ICH and GCP guidelines.
    • Medical data review and data interpretation experience.
    • Ability to perform complex data analysis.
    • Clinical presentations about clinical data to investigators and site staff.
    • Represent the company at SIVs, site visits and medical congresses.Working Conditions
      • Availability during normal Pacific time business hours.
      • Availability to meet with clinical study centers and travel to company headquarters for meetings as needed. (5-10% travel).
        Director, Clinical Sciences Salary Range: $198,000 to $248,000 annuallySenior Director, Clinical Sciences Salary Range: $251,000 to $300,000 annually The final pay offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience with the industry, education, geographic location, etc.
        Who We Are and What We Do Based in San Diego, Poseida Therapeutics is a clinical-stage biopharmaceutical company utilizing our unique and proprietary genetic engineering platform technologies to create next-generation cell and gene therapies with the capacity to cure. We are passionate about making an impact on patients' lives with the development of our CAR-T therapies in various cancers and gene therapies for rare diseases. Our goal is to deliver potential single treatment cures for patients in need. Our portfolio of product candidates is specifically designed to overcome the limitations of current generation cell and gene therapeutics.
        At Poseida we put people first. Our team is passionate about improving patients' lives through innovation. See what our team has to say about our culture:
        "My favorite part about Poseida is all the people that I get to work with. Everyone is so passionate about what we're doing here and there's so much camaraderie. It feels like one big enthusiastic family."
        "My favorite part about working at Poseida is the amazing culture and working environment. Everybody is friendly, professional, collaborative, and has a remarkable can-do and positive attitude."
        As we advance our compelling pipeline, there are endless opportunities for impact and growth. We encourage you to apply today

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