In 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 Summary

Poseida 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, 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).