Medical Director/Senior Medical Director- CAR-T Solid Tumors

Company: Poseida Therapeutics
Location: San Diego
Posted on: August 7, 2022

Job Description:

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Description
Please note that we can accommodate this as a remote based role. We can consider remote based employee in the following states:CaliforniaArizonaNevadaTexasFloridaNew JerseyWashingtonMassachusettsMarylandPennsylvania Michigan
Position SummaryThe Medical Director will be responsible for leading Poseida's CAR-T solid tumors drug programs. He or she will lead clinical protocol development, enrollment to clinical studies, safety monitoring and review, biomarker development, implementation and analysis of data, manuscript writing and submission, as well as presentation of data at national and international meetings. The incumbent will partner with and lead a cross functional development teams.This position will have a strong outward facing presence and will directly engage in protocol development, site evaluation and selection, trial conduct, data analysis and safety monitoring for clinical trials. The role functions internally as a medical expert and medical monitor to support the development and execution of an efficient and integrated global medical/scientific strategy, including scientific evidence generation and scientific information exchange with key stakeholders.
Responsibilities These may include but are not limited to:

• Lead and demonstrate ownership of the design and implementation of clinical development programs in support of the overall product development plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, markets, business operations, and emerging issues.
• Oversee project-related education of investigators, study site personnel, and study staff.
• Cultivate and advance a clinical development strategy and integrated development plans, design, biomarker and implementation of Phase I-III clinical studies.
• Support R&D management and the business development team with input on clinical development issues related to the BD plan, and support the business development process by providing medical expertise for in- or out-licensing, partnering and acquisition activities.
• Responsible for the clinical content of clinical and regulatory documents, including protocols, INDs, CTAs, investigator brochures, CRF's, annual IND reports, CSR's, BLA's NDA's, ISS's, ISE's, and clinical expert reports.
• Lead and supervise clinical trials/registries, collaborating closely with the Clinical Operations team, and will be accountable for all deliverables of clinical trials under his/her direct responsibility.
• Serve as Medical Monitor and the Sponsor's medical representative to multiple vendors and collaborators; CROs, PIs, core laboratories and other organizations involved in the implementation of clinical trials.
• Responsible for analysis of clinical data, including safety monitoring, and implement appropriate pharmacovigilance actions, if necessary.
• Develop and maintain relationships and serve as the main medical liaison with key opinion leaders and PIs.
• Organize and present at relevant clinical advisory boards and medical/scientific meetings as needed.
• Assist in the review of Investigator-Initiated studies and in the identification of clinical sites.
• Prepare and present documentation of clinical trial results to corporate committees, regulatory agencies, and outside audiences, and publish results of research projects.
• Help ensure Clinical Study Team compliance with FDA, EMEA, ICH and GCP guidelines and internal SOPs.
• Provide medical insight into Advisory Board meetings, learning materials for internal and external use.
• Contribute to business development efforts.
• Participate, as requested, as clinical expert on due diligence teams related to external in-licensing opportunities.
• Partner with the business development team to evaluate novel targets and platforms in the immuno-oncology and/or gene therapy space.
  Requirements
  Requirements, Knowledge, Skills and Abilities
  • M.D with board certification/eligibility with a minimum of 2 plus years of relevant clinical research experience in clinical development in the biopharmaceutical industry; prior experience working on industry-sponsored trials with oncology. Solid tumor experience and CAR-T experience is preferred.
  • Thorough understanding of Phase I-III drug development with proven ability to plan clinical trials, deliver high quality results within established timelines, interpret, analyze and communicate clinical/scientific data, conduct medical monitoring / safety assessment / pharmacovigilance and generate clinical/scientific documents.
  • Ability to work independently and thrive in a fast-paced environment.
  • Demonstrated track record of success in your field, the capacity to lead with minimal supervision, plan strategically, achieve goals on time, and communicate effectively.
  • Excellent written and verbal communication skills to meet the needs of varied audiences.
  • Strong interpersonal and communication skills commensurate with the need to work closely with partners, investigators, contractors, consultants, and team members across functions.
  • Knowledge of FDA/EMA requirements, good clinical practices and pharmaceutical clinical development.
  • Excellent analytical, problem-solving and strategic planning skills.
  • Well organized with strong management, leadership, mentoring and motivational skills.
  • Attention to detail, demand for high-quality work, and sense of passion and urgency to achieve goals and improve the lives of patients.
  • Strong business acumen, including working knowledge of changing U.S. payer and provider landscape.
  • Extensive knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in development of clinical strategy and the design of Study protocols.
  • Proven leadership skills and ability to bring out the best in others on a cross-functional team; highly collaborative, team oriented and decisive.
  • Able to lead through influence.
  • Some travel required

Keywords: Poseida Therapeutics, San Diego , Medical Director/Senior Medical Director- CAR-T Solid Tumors, Executive , San Diego, California