Medical Director/Senior Medical Director- CAR-T Solid Tumors
Company: Poseida Therapeutics
Location: San Diego
Posted on: August 7, 2022
Please note that we can accommodate this as a remote based role. We
can consider remote based employee in the following
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
- 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
- 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
- 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
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
- Ability to work independently and thrive in a fast-paced
- 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
- 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
- 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
- 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
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