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SystImmune · Princeton, New Jersey
Contributes to developing the program strategy for assigned trials/compounds
Author components with the Medical Director and reviewer of clinical and regulatory documents and registration dossiers (i.e., protocol, ICF, IB, safety updates, study reports, regulatory submissions, etc.) to support registration and commercialization of the compound(s)
Contributes to the development of eCRFs and eCRFs completion guidelines and provides scientific support for other key data management deliverables (e.g., database lock activities).
Lead the development of a medical data review plan, medical monitoring plan, perform ongoing medical data review, and summarize efficacy and safety data for interpretation/analysis
Provide input for country/site selection and feasibility assessment and interact with KOLs
Prepare charters and coordinate internal/external committee meetings including presentations and discussion with senior leadership
Participate in the development and review of study plans and liaise with project teams
Prepare presentations for Investigator meetings, site personnel, CRA training, pre-study site visits (SEVs), and site initiation visits (SIVs)
Provide input for developing publications in coordination with the Scientific Communications/Publishing department
Bachelor’s degree in life sciences or health-related field with an advanced degree such as a Masters, PharmD, PhD in biological/pharmaceutical science, or MD
Minimum requirement: at least 8 or more years industry experience including pre-clinical as well as clinical research
Therapeutic areas of expertise must include hematology.
Advanced knowledge and skills to support program-specific data review, trend identification, data interpretation
Knowledge of the International Council of Harmonization (ICH), GCP, and other relevant regulatory guidelines
Advanced ability to analyze clinical information succinctly and efficiently with strong written communication.
The expected base salary range for this position is $ 180,000 to $245,000
annually. Actual compensation will be based on a variety of factors, including but not limited to a candidate’s qualifications, experience, and skills.
SystImmune is a leading and well-funded biotech company with a bright future. We offer an opportunity for you to learn and grow while making significant contributions to the company’s success. SystImmune offers a comprehensive benefits package including: 100% paid employee premiums for medical/dental/vision, also STD, LTD, a 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years, 15 PTO days per year, sick leave, plus 11 paid holidays and MORE.
We offer an opportunity for you to learn and grow while making significant contributions to the company’s success.
SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.
Details
| Company | SystImmune |
| Location | Princeton, New Jersey |
| Type | FULL TIME |
| Niche | Full-time |
| Salary | $1,80,000 – $1,80,000 / yr |