The Vice President of Translational Medicine will be responsible for overseeing the generation and analysis of cell kinetics and biomarker data obtained from Poseida’s clinical trials. You will aid in guiding strategic decision-making to drive successful clinical development of product candidates, driving Poseida’s mission to cure patients of cancer.

Position Summary

Poseida Therapeutics is seeking a Vice President of Translational Medicine to join the team. You will oversee and provide guidance to enhance our capabilities in translational research activities in support of our clinical assets. This role will be responsible for leading a multidisciplinary team of scientists and operational experts, providing strategic direction, mentorship, and support to foster a culture of collaboration, innovation, and excellence. The candidate will also oversee development and validation of biomarkers and cell kinetics for the implementation and evaluation in clinical studies. Additionally, the candidate will interact with the therapeutic discovery teams, the technical operations group, and the clinical team to develop and implement strategies for therapeutic development, strategies for potency assay development, and applications of biomarker assays across clinical programs. The candidate will have strong experience and a track record with oncology therapeutic development, particularly cell therapies, as well as clinical trials for different malignancies.

Responsibilities 

• Lead translational and biomarker development and strategies for the portfolio of allogeneic cell therapeutics.
• Partner within a matrixed organization, acting as the lead interface between groups including discovery research, technical operations, regulatory affairs, translational medicine, clinical development and project leadership, and also with external partners, to deliver on high-quality translational, biomarkers and cell kinetics plans for all product candidate programs.
• Provide guidance, oversight, scientific input, and expertise for execution and review of all aspects of translational development plans, academic collaborations including resultant publications and posters, and for relevant internal documents (regulatory submissions, sample collection tables, sample collection instructions and logistics, investigator brochures, and clinical protocols).
• Ensure the output of the biomarker plans meets established program standards (within budget, on schedule, compliance, etc.), while looking for opportunities to streamline progress without compromising quality, making sure that Translational Sciences is focused on key assets, and that plans are integrated within the broader Translational strategy Ensure the progress of translational plans into their implementation and execution through internal assay execution and/or development with external contract research organizations (CROs) and specialty testing labs.
• Support due diligence and asset integration activities as needed. Proactively provide insight into novel ways to incorporate biomarkers into clinical designs to enable early understanding of emerging therapy profiles.
• Communicate key program information, risks, risk mitigation and milestones, and manage information flow across key stakeholders including therapeutic area leadership, functional leads, and team members Independently engage with development teams and technical/scientific experts to define, revise and progress plans. Collaborate and strategize across the entire organization to improve efficiency and accelerate the product pipeline forward.
• Participate in strategic overview of presentations, publications, and internal/external communications along with accountable program leadership.
• Balance multiple priorities in a fast-paced, team-based environment and work independently when needed, building structure from ambiguity, and helping teams to develop priorities.
• Ensure compliance with cGMP, GLP, and regulatory guidelines

Requirements, Knowledge, Skills and Abilities

• Advanced degree (MD or PhD) in the Life Sciences field with 15+ years’ industry experience, or an equivalent combination of education and experience
• Experience with both large pharma and biotech preferred.
• Proven expertise in cell therapy, experience in other disease areas also a plus.
• Experience in bringing cell and gene therapy drug candidates from pre-IND through PI/II and, ideally, to BLA preferred
• Prior experience supporting health authority interactions.
• First-hand knowledge of and experience with assays relevant for cell therapies including flow cytometry, IHC, qPCR, anti-therapeutic antibody assessment, T-cell antigen specific response assays, and serum cytokine quantification
• Thorough knowledge of ICH, GCP, GLP guidelines to ensure ethical and compliant conduct of clinical studies in U.S., Europe, and RoW; experience with regulatory inspections and audits is preferred
• Working knowledge of statistical methods and models for data analysis
• Experience in working with computational data scientists
• Proven history of building relationships and fostering engagement across stakeholders, including the senior management, scientific and clinical advisory boards, academic and biopharma partners, and CROs
• Proven experience partnering with drug discovery to identify and develop candidates by continuous integration of learnings from correlative clinical data and exploratory biomarker studies to define next generation products
• Interface with pharma and biotech strategic partners as needed. Experience with partnerships a plus
• A track record of representing the company with scientific presentations, panel discussions and other forums is highly desired.
• Sound business acumen with a pragmatic, collegial, results-oriented leadership style that can translate innovation, creative strategies, and conceptual thinking into plans.
• Excellent leadership and management skills to inspire, coach, mentor, and develop a strong team