Clinical stage biopharmaceutical company with the scientific vision of revolutionizing the treatment of rare diseases. Company specializing in the research, clinical development, and near future commercialization of products being developed. The company is building additional portfolio of therapies addressing a wide range of disease states for the betterment of patient cures.
In depth workings within the clinical study team including the medical director, biostatistician, project management, data management, and other clinical study personnel. This position will have significant interaction with executive leadership, physicians and regulatory (FDA) authorities. In addition, required to execute job responsibilities within company policies and standard operating procedures (SOP). Role defined as:
- Design clinical trials and studies in collaboration with internal stake holders including clinical project management, clinical operations, clinical science, biostatistics data management, regulatory affairs, medical affairs as well as external stake holders including steering committees, and national principal investigators (if applicable).
- Lead the generation of study-related documents and/or contribute content and oversight of such documents, including, but not limited to, clinical study protocols, case report forms, clinical study reports, and informed consent forms.
- Critically analyze data and present to internal and external groups including but not limited to clinicians and cross-functional team members.
- Actively participate in internal and external scientific meetings by presenting and critically evaluating the science and contributing to projects.
- Develop the scientific podium and publication strategy in close collaboration with cross-functional teams, and lead the execution of the publication strategy.
- Lead publications for clinical study data through coordination with investigator authors and project management of reviews and revisions for abstracts and manuscripts.
- Support in developing clinical evidence generation plans.
- Serve as an active member of study teams and provide scientific support to justify trial design and ongoing scientific analysis during protocol development. May include generation of pre-protocol documentation of scientific information.
- Synthesize literature and competitive information across multiple products and/or therapies within the assigned therapeutic area.
- Review and critically analyze statistical analysis plans.
- Lead study level (and franchise level where applicable) publication planning.
- Generate documents to support regulatory submissions for company products and/or respond to questions from regulatory authorities about existing submissions.
- Contribute to the optimization of internal processes and workflows.
- Develop new ideas for both external and internal projects.
- Attend, present at, and/or leads meetings with FDA.
- Performs other related duties and responsibilities, on occasion, as assigned.
- BS degree required, advanced degree (MS, PhD) preferred in Statistics, Math, sciences and medicines.
- Minimum of 6+years of related work experience with a complete understanding of specified functional area.
- Comprehensive knowledge of therapeutic area specified.
- Uses in-depth knowledge of business unit functions and cross group dependencies/ relationships.
- Expertise in work group and across functions. Will perform this job in a quality system environment.
- Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
- Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
- Has broad knowledge of various technical alternatives and their potential impact on the business.
up to $175K+ plus Annual Bonus + Stock Options
New Jersey/NY/CT Area
No, not at this time.
FE - 1915