Leading biotechnology company specializing in the research, clinical development, and commercialization of cancer immunotherapy treatments. Global leader in employing cell and gene therapy to treat cancer. Company currently conducting first US FDA-registered T cell therapy trial for various cancer indication. Multiple locations in US and worldwide. In addition, a robust pipeline of both pre-clinical and clinical treatments, targeting multiple cancer indications.
Company mission is to cure cancers and save lives with our innovative and widely accessible immunotherapies.
Lead the development of clinical programs:
- Work closely with Chief Medical Officer and President, R&D and other stakeholders to plan and implement medical and clinical strategies.
- Responsible for driving clinical development plans, clinical trial protocols, clinical pharmacology, data analyses, clinical study reports, and other related clinical documents.
- Design clinical trials in line with strategic objectives; ability to anticipate and address future commercial and clinical development needs.
- Partner with internal and external experts and consultants to refine the clinical development plan and to optimize the scientific integrity of the methodology and ensure that the overall scientific and medical content of all clinical programs is sound.
- Work with opinion leaders and expert consultants to keep development plans attuned to recent advances in clinical, scientific, regulatory and competitive environments.
- Lead and motivate the clinical operations team to effectively and efficiently operationalize the clinical development strategy (i.e. clinical trials management).
- Work closely with Program Management team to integrate resources, to align operational activities between functions, to maximize efficiency and meet timelines.
- Able to critically evaluate new business opportunities and potential new product candidates from a clinical/safety perspective; participate in evaluations and due diligence activities.
- Provide medical/clinical insight into competitive developments.
- Lead the development of clinical portions of INDs, IBs, CTAs, BLAs and other regulatory submissions.
- Provide periodic literature review and keep up to date with developments in relevant indications and therapeutic areas.
- Line management accountability for promotions, recruitment strategy and team structure.
Trial planning, execution and oversight:
- Serve as US Chief Medical Oversight for a program/study portfolio.
- Provides and documents oversight on medical monitoring plan/activities.
- Reviews safety reports/data during study conduct; ensure monitoring / reporting of AEs/SAEs; defines product level surveillance plan and interpretations.
- Oversee medical monitors across regions.
- Oversee trial feasibility and site selection process in collaboration with Trial Monitoring organization.
- Conduct investigator meetings/trainings.
- Support implementation of global recruitment plan including contingencies in collaboration with Trial Monitoring.
- Manage and oversee resolution of trial operational issues.
- Provide updates on trial progress to relevant boards.
- Provide oversight on quality and compliance for all clinical trial(s) programs.
- Manage and contribute to the development of Clinical Study Reports, reporting of clinical trial results and internal/external publications.
- MD degree required; Board Certified desired with extensive clinical experience.
- At least 10 years of clinical oncology development experience within the Biotech or Pharmaceuticals industry, with focus in Oncology.
- Preferred clinical background in Oncology.
- Possess good Oncology early trial scientific affairs or early pre-clinical/clinical trial development experience.
- Understanding of related disciplines (e.g. biostatistics, regulatory, pre-clinical pharmacology, pharmaceutical sciences).
- Experience in building teams and functions.
- Demonstrated scientific productivity (publications, abstracts, etc).
- Experience in functioning effectively as a member of a matrixed/multidisciplinary team.
- Demonstrated effectiveness in people management, communication and colleague development.
- Exceptional verbal and written communication and presentation skills.
- Global travel up to 30%.
up to $400K+ plus Annual Bonus + Equity Options package
East Coast (Remote location acceptable)
No, not at this time.