Director, Clinical Science - Oncology Biotech

SystImmune, Inc.; Princeton (NJ); On-site; USD 180,000 - 230,000; Full time

Benefits offered by this job

Premium medical/dental/vision

STD/LTD

401(k) match

PTO 15 days + 11 holidays

Job summary

SystImmune, Inc. in Princeton, NJ is seeking a Senior Clinical Data Lead to drive program strategy for assigned trials and contribute to regulatory submissions across hematology programs.

The role emphasizes data review, safety monitoring, and collaboration with medical experts to support registration and commercialization. The ideal candidate has a life sciences degree with 8+ years in industry, strong knowledge of ICH/GCP, and proven ability to communicate complex data clearly to

Qualifications

• Bachelor’s degree in life sciences plus an advanced degree (MS/PhD/MD).
• 8+ years in industry including pre-clinical and clinical research.
• Hematology experience preferred.
• Strong knowledge of ICH and GCP regulatory guidelines.
• Excellent written communication and data interpretation skills.

Responsibilities

• Contributes to developing the program strategy for assigned trials/compounds.
• Author regulatory documents and submission dossiers to support registration and commercialization.
• Develop eCRFs and guidelines for data collection and monitoring.
• Lead medical data review plans and summarize efficacy and safety data.
• Interact with KOLs and assist site/faceted country selection discussions.
• Coordinate committee meetings and prepare presentations for leadership.

Skills

Program strategy

Clinical data review

Regulatory submissions

Medical monitoring

Scientific communication

Cross-functional collaboration

Education

Advanced degree in life sciences

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 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.
• Outstanding track record of strong communication, presentation, analytic, and strategic capabilities and ability to effectively collaborate with medical experts

Compensation and Benefits:

The expected base salary range for this position is $180,000 to $230,000 annually. Actual compensation will be based on a variety of factors, including but not limited to a candidate’s qualifications, experience, and skills.

• 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.