Sr. Manager/Associate Director, Clinical Science - Oncology Biotech

SystImmune; Princeton (NJ); On-site; USD 150,000 - 210,000; Full time

Benefits offered by this job

100% paid premiums

STD/LTD insurance

401(k) with company match

Vesting after 5 years

15 PTO days per year

11 paid holidays

Job summary

SystImmune is seeking an experienced Clinical Scientist to contribute to program strategy for trials targeting hematology indications. You will author and review key clinical and regulatory documents with the Medical Director to support regulatory submissions and commercialization.

The role emphasizes medical data review, plan development for data monitoring, and collaboration with senior leadership and internal teams, ensuring rigorous data interpretation and communication.

Qualifications

• Bachelor’s degree in life sciences or health field; advanced degree required (Masters/PhD/MD).
• Minimum 5+ years industry experience as a Clinical Scientist.
• Therapeutic hematology expertise required.

Responsibilities

• Contributes to developing program strategy for trials/compounds.
• Author documents (protocol, ICF, IB, safety updates) with Medical Director for registrations.
• Develops eCRFs and guidelines; supports data management deliverables.

Skills

Clinical data review

Communication skills

Regulatory knowledge

Cross-functional collaboration

Education

Advanced degree (Masters/PhD/MD)

Tools

ICH/GCP knowledge

Job 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.

Responsibilities:

• 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

Qualifications:

• 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 5 or more years industry as a Clinical Scientist
• 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.
• Outstanding track record of strong communication, presentation, analytic, and strategic capabilities and ability to effectively collaborate with medical experts

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.