Manager, Clinical Science
About The Position
SystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Redmond, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials. SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discover and IND-enabling stages, representing cutting-edge biologics development. We offer an opportunity for you to learn and grow while making significant contributions to the company's success. We are seeking a motivated Manager, Clinical Science to join our clinical development team and contribute to the advancement of innovative therapeutic programs. This role provides an excellent opportunity to gain hands-on experience in clinical trial design and execution while working alongside experienced clinical development professionals in a dynamic biotech/pharmaceutical environment.
Requirements
- Degree in life sciences or health-related field
- Minimum requirement: at least 3-4 years’ industry experience (clinical research preferred)
- Therapeutic areas of expertise must include oncology.
- Experience with data cleaning, visualization, and basic statistical analysis (Excel mandatory, R optional)
- Knowledge of the International Council of Harmonization (ICH), GCP, and other relevant regulatory guidelines.
- Ability to analyze, interpret and socialize data to internal and external stakeholders
- Strong communication, presentation, analytic, and strategic capabilities and ability to effectively collaborate with medical experts.
- Ability to think strategically and creatively, function independently, deliver on timelines, and contribute strategic insights
Responsibilities
- Monitor, review, and summarize safety and efficacy data in 1 or more ongoing studies on a regular basis
- Work in close collaboration with the clinical team to ensure translation of the clinical protocol (and amendments) into operational deliverables, including but not limited to performing ongoing review and analysis of clinical study data and preparing/reviewing study plans (i.e., Medical Monitoring, Medical Data Review, Safety Management, CRF Completion Guidelines, etc.)
- Respond to study questions from sites and/or vendors, with study medical monitor or Clinical Development supervision where needed
- Perform literature search and critically review and summarize the relevant scientific, drug development, and medical literature to support new clinical trial design as well as the development of clinical and/or regulatory documents
- Support preparation of scientific material
- Contribute to the development of SOPs and associated guidelines and templates
- Participate in cross-functional team meetings with members from clinical operations, safety, regulatory, biostatistics and data management
Benefits
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Number of Employees
11-50 employees
