Manager, Clinical Science at Systimmune

Princeton, New Jersey, United States -

Full Time

Start Date

Immediate

Expiry Date

04 Mar, 26

Salary

130000.0

Posted On

05 Dec, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Trial Design, Data Analysis, Oncology, Communication, Presentation, Strategic Thinking, Collaboration, Literature Review, SOP Development, Medical Monitoring, Data Review, Safety Management, Statistical Analysis, Regulatory Guidelines, Clinical Research, Biopharmaceuticals

Industry

Biotechnology Research

Description

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. 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 Qualifications 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 Compensation and Benefits: The expected base salary range for this position is $80,000 to $130,000 annually. Actual compensation will be based on a variety of factors, including but not limited to a candidate’s qualifications, experience, and skills. While most offers typically fall within the low to mid-point of the range, we may extend an offer toward the higher end for exceptional candidates whose background and expertise exceeds the requirements of the role. 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.

Responsibilities

The Manager, Clinical Science will monitor and summarize safety and efficacy data in ongoing studies and collaborate with the clinical team to translate clinical protocols into operational deliverables. This role also involves responding to study questions and performing literature searches to support new clinical trial designs.