Innovative pharma/biotech company with a robust and diversified late stage pipeline of innovative products in rare disease. Company specializing in the research, clinical development, and near future commercialization of rare disease with many of the drugs being developed will be the first and only approved treatments for the diseases and conditions that they target.
- Lead the development of clinical programs and work closely with Vice President, R&D, Chief Medical Officer, 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.
Trial planning, execution and oversight:
- Serve as 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.
- PharmaD, MS/PhD or equivalent degree with extensive clinical experience.
- At least 7 – 8 years of clinical development experience within the Biotech or Pharmaceuticals industry, with focus in rare disease, immunology, dermatology, etc. experience a plus.
- Possess good 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).
- 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.
up to $225K+ plus Annual Bonus + Stk Options
New Jersey/PA/NY Area
No, not at this time.
WP - 828