Executive / senior industry position
The Medical Director will be responsible for assisting in implementation of Posieda’s drug development strategies and will lead individual drug program(s). He or she will provide clinical input on clinical protocol development, regulatory issues, and patient 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. This position will have a strong outward facing presence and will support investigator-initiated trials and assist in the protocol review, site evaluation and selection process for clinical trials. The role functions internally as a medical expert/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.
The Medical Director is preferably a board-certified physician. The ideal candidate will have history of clinical research or some industry experience in the Oncology and/or Gene Therapy therapeutic areas. The Medical Director is knowledgeable of the actions of regulatory bodies and has experience in all aspects of clinical trials. The ideal candidate should have significant experience in their medical specialty and would thrive on proactively engaging internal and external leaders and will serve as a medical expert for their compound(s) and/or disease area. He or she will have strong commercial aptitude and/or experience, including proven ability to translate and appropriately align commercial and scientific goals and objectives. S/he will have solid peer relationships with external scientific and clinical experts. The individual must have the ability to work independently and as an effective and engaged team member in a fast-paced environment. Strong initiative and follow through are essential for this job. The ability to maintain confidentiality and to operate in the role with the highest of ethical standards and professionalism are required.
ResponsibilitiesThese may include but are not limited to:
- Lead and demonstrate ownership of the design and implementation of a clinical development program or 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.
- Help cultivate and advance a clinical development strategy and integrated development plans, design, biomarker and implementation of Phase I-III clinical studies.
- Closely interface with other functional areas relevant to clinical development.
- Support R&D management and the business development team with input on clinical development issues related to their BD plan, and support the business development process by providing medical expertise for in- or out-licensing, partnering and acquisition activities.
- Be responsible for the clinical content of clinical and regulatory documents, including protocols, INDs, CTAs, investigator brochures, CRF’s, annual IND reports, CSR’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.
- Be responsible for analysis of clinical data, including safety monitoring in collaboration with PV, 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.
- Develop and/or review clinical trial protocols and serve as medical lead for trial conduct.
- 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.
- Establish and maintain contact with external experts, opinion leaders and strategic partners in academia, government and industry.
- Supply medical input into safety profile of the products and work with commercial teams to provide scientific and clinical expertise/input into strategic and tactical decisions.
- Ensure that all clinical programs follow all applicable regulations.
- Helps with review and analysis of patient safety data and implement any protocol changes mandated by safety concerns.
- Help ensure Clinical Study Team compliance with FDA, EMEA, ICH and GCP guidelines and internal SOPs.
- Contribute to scientific and clinical communications.
- Participate in meetings and committees of parent company or other affiliates.
- Monitor global scientific/medical literature.
- Complete scientific reports, manuscripts and other educational materials.
- Work with investigators to identify publication and abstract opportunities.
- Help to identify opportunities for data presentation and representation at national and international meetings and conferences.
- Provide oversight for internal review of manuscripts and data presentations.
- 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 space.
Requirements, Knowledge, Skills and Abilities
- M.D. with board certification/eligibility
- 2-5+years of relevant clinical research experience in clinical development and/or medical affairs in the biopharmaceutical industry preferred; prior experience working on industry-sponsored trials with oncology, immunotherapy, gene therapy or CAR-T cells 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, and generate clinical/scientific documents.
- A 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 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.
- Ability to work independently and thrive in a fast-paced environment.
- 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.
- Excellent communication and presentation skills are essential.
Who We Are and What We Do
Poseida is a San Diego based biotechnology leader in the development of cell and gene therapies. We have built a wholly-owned pipeline of autologous and allogeneic chimeric antigen receptor T cell, or CAR-T, product candidates, initially focused on the treatment of hematological malignancies and solid tumors. Here at Poseida we are constantly innovating and growing as we advance our CAR-T therapies in the clinic and our gene therapies currently under development. The Poseida team is passionate about the impact we are making in developing treatments, or even cures, for patients with cancer or other genetic diseases.
The company’s CAR-T product candidates are manufactured with Poseida’s non-viral piggyBac® DNA Modification System, resulting in a high percentage of stem cell memory T cells (TSCM). Tscm cells are the only T cells that are self-renewing and long-lived, potentially resulting in product candidates that are more efficacious, less toxic and more durable. Poseida is currently developing the following CAR-T product candidates:
- P-BCMA-101 is an autologous CAR-T therapy for the treatment of relapsed/refractory multiple myeloma, currently enrolling patients for a Phase 2 registrational trial with initial dosing expected in the first half of 2019.
- P-PSMA-101 is an autologous CAR-T product candidate targeting PSMA-specific cancer cells in castrate resistant prostate cancer, with filing of an IND anticipated in the second half of 2019.
- P-BCMA-ALLO1 is an allogeneic, or universal donor, CAR-T product candidate, manufactured using Poseida’s proprietary Cas-CLOVER™ site specific gene editing system and is being developed as a treatment for relapsed/refractory multiple myeloma, with an IND filing anticipated by late 2019 or early 2020.
- P-MUC1C-101 is an autologous CAR-T product candidate in late-stage preclinical development for numerous solid tumor indications, including ovarian, breast, lung, colorectal, pancreatic and renal cancers, with filing of an IND anticipated in 2020.
Poseida plans to broadly advance its current CAR-T programs and emerging pipeline programs, including gene therapies for orphan genetic diseases.
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