Head of Clinical Development, Oncology
San Diego, CA Clinical Development
Description

Your Impact

At Poseida Therapeutics, we are moving closer every day to transforming the treatment of life-threatening diseases. Our gene engineering technologies represent the next wave of innovation giving new hope to patients with cancer and genetic disease. As a member of the Poseida team, you will have the opportunity to help us bring this mission to life.


Position Summary

Poseida Therapeutics is seeking an experienced and highly motivated individual to head Clinical Development. The successful candidate will lead and build a high-performing clinical development team covering all aspects of our development capabilities to deliver our oncology strategy. This includes responsibility for overall clinical strategy, protocol design and execution, clinical operations, CRO oversight, quality assurance and data analysis. This person will work closely with R&D leadership to ensure effective transition from discovery and delivery through development phases. The position will report to the President, Oncology and will be located in San Diego, CA.


Responsibilities

  • Responsible for the delivery of clinical development strategy in support of the oncology pipeline
  • Build, develop, and oversee the Clinical Development organization with the goal of establishing a culture of excellence and creativity.
  • Drive the development of oncology protocols by leading and partnering with cross-functional development teams, including Medical, Clinical Operations, Translational Medicine, Biomarkers, Statistics, Safety, Quality and Regulatory.
  • Play a leadership role in the design and high-quality implementation of clinical studies.
  • Oversee development and execute clinical delivery strategy, including CRO and site selection, contracting, initiation, monitoring, and reporting
  • Develop and manage the clinical study budget, timelines and develop viable contingency/mitigation plans
  • Develop, articulate, and gain alignment across the organization on the necessary Clinical Operations policies, and procedures that support advancement of the company’s pipeline.
  • Contribute to strategic planning to ensure clinical development plans are optimized
  • Establish and promote an environment of unparalleled quality and rigorous adherence to process and documentation to ensure regulatory compliance and successful product development.
  • Serve as a member of the Senior Leadership Team and provide enterprise-wide clinical perspective on Poseida’s ongoing research and development programs, potential in-licensing transactions, and general corporate governance.
Requirements

Requirements, Knowledge, Skills and Abilities

  • Ph.D., M.D. or M.D./Ph.D. in Clinical Science or relevant discipline
  • Minimum of 15 years' experience in oncology clinical development in a biotech or entrepreneurial pharmaceutical environment
  • Experience with oncology trial design, execution, and analysis in cell therapies
  • Knowledge of regulatory requirements, good clinical practices, and pharmaceutical clinical development
  • Proven track record in building and managing a high performing Clinical team including clinical operations, medical monitoring/safety/clinical sciences, statistics and data science, biomarkers and translational medicine
  • Comprehensive understanding of GCP, ICH, and clinical study regulations
  • Evidence of creativity in addressing challenging clinical science problems
  • Strong leadership skills with demonstrated ability to manage high performing cross-functional teams, mentor, coach and promote career development
  • Experience working in a team setting, and the ability to facilitate productive exchanges with team members at all levels through strong management, leadership, mentoring, and motivating
  • Experience leading external CRO and similar vendors in support of internal clinical and regulatory matters
  • Experience working in a collaboration or strategic partnership environment 
  • Ability to work independently and thrive in a fast-paced environment, with a sense of passion and urgency to achieve goals and improve patient outcomes

  

Salary Range: $357,973 to $401,700

The final salary 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!