Director of Clinical Science - ImmunoOncology

Systimmune • Princeton, NJ

10d • $180,000 - $240,000

About The Position

SystImmune is seeking a Director of Clinical Science to contribute to the development and execution of program strategy for assigned trials and compounds. The role supports clinical and regulatory documentation, scientific data review and interpretation, study planning, and collaboration with internal teams, external committees, investigators, and key opinion leaders. The position focuses on clinical development in oncology; the qualifications specify expertise in hematology.

The Director authors and reviews clinical and regulatory documents with the Medical Director, supports data management deliverables, leads medical data review planning and ongoing review, and helps assess study feasibility and select countries and sites. The role also coordinates committee meetings, prepares study and training presentations, and contributes to scientific publications. SystImmune describes itself as a clinical-stage biopharmaceutical company developing cancer treatments, including bispecific and multispecific antibodies and antibody-drug conjugates.

The expected base salary range is $180,000 to $240,000 annually. SystImmune offers a comprehensive benefits package, including paid employee medical, dental, and vision premiums; short- and long-term disability; a 401(k) plan with a company match; paid time off; sick leave; and paid holidays.

Requirements

• Bachelor’s degree in life sciences or a health-related field, with an advanced degree such as a master’s, PharmD, PhD in biological or pharmaceutical science, or MD.
• At least 8 years of industry experience, including preclinical and clinical research.
• Therapeutic-area expertise that includes hematology.
• Advanced knowledge and skills supporting program-specific data review, trend identification, and data interpretation.
• Knowledge of International Council for Harmonisation (ICH), GCP, and other relevant regulatory guidelines.
• Advanced ability to analyze clinical information succinctly and efficiently, with strong written communication skills.
• Strong communication, presentation, analytical, and strategic capabilities, and the ability to collaborate effectively with medical experts.

Responsibilities

• Contribute to developing program strategy for assigned trials and compounds.
• Author clinical and regulatory document components with the Medical Director and review clinical and regulatory documents and registration dossiers, including protocols, informed consent forms, investigator brochures, safety updates, study reports, and regulatory submissions.
• Contribute to the development of eCRFs and eCRF completion guidelines, and provide scientific support for data management deliverables such as database lock activities.
• Lead development of medical data review and medical monitoring plans; perform ongoing medical data review; and summarize efficacy and safety data for interpretation and analysis.
• Provide input on country and site selection and feasibility assessments, and interact with key opinion leaders.
• Prepare charters and coordinate internal and external committee meetings, including presentations and discussions with senior leadership.
• Participate in developing and reviewing study plans and liaise with project teams.
• Prepare presentations for investigator meetings, site personnel, CRA training, pre-study site visits, and site initiation visits.
• Provide input for developing publications in coordination with the Scientific Communications/Publishing department.

Benefits

• 100% paid employee premiums for medical, dental, and vision insurance.
• Short-term disability (STD) and long-term disability (LTD).
• 401(k) plan with a 50% company match of up to 3%, with a five-year vesting schedule.
• 15 PTO days per year.
• Sick leave.
• 11 paid holidays.

What This Job Offers

• Job Type: Full-time
• Career Level: Director