Director of Clinical Science

Systimmune
Princeton, NJ

Role and 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 oncology.
  • 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 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 discovery or 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. SystImmune offers a comprehensive benefits package.

SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.

Posted 2025-08-06

Recommended Jobs

Heavy Equipment Mechanic

TSS
West Orange, NJ

Job Description Job Description Basic Job Description: Diagnose, adjust, repair, or overhaul mobile mechanical, hydraulic, and pneumatic equipment, such as cranes, bulldozers, graders, and con…

View Details
Posted 2025-07-28

Head Automotive Service Technician

Car House
Butler, NJ

Job Description Job Description The Car House, located in Butler NJ is a member of Northern New Jersey’s largest independent pre-owned dealer group, consisting of four locations and over 1,000 q…

View Details
Posted 2025-07-26

Chiropractor Woodcliff Lake NJ (10 miles N of Hackensack)

Healthcare Recruitment Counselors
Woodcliff Lake, NJ

Chiropractor Woodcliff Lake NJ (10 miles N of Hackensack) No weekend work! We are looking for a motivated Chiropractor to join our practice full time in Woodcliff Lake, NJ. We are looking for a Ch…

View Details
Posted 2025-07-27

Eye Care Assistant/Technician

First Eyecare
Hoboken, NJ

Job Description Job Description Provision Eyecare is the premier, full-service destination for high quality eye care and eyewear. The Eye Care Assistant at Provision creates exceptional value …

View Details
Posted 2025-07-27

Property Sales Field Assistant - NJ

Blue Banana Properties, L.L.C.
Mountainside, NJ

Stephen Swank is the Founder and President of Blue Banana Properties LLC, a prominent, multi-pronged real estate firm with national reach. Stephen began acquiring properties shortly after graduating f…

View Details
Posted 2025-07-30

Venue And Event Worker

Mount Laurel, NJ

Job Description Venue And Event Worker PeopleReady of Pennsauken, NJ is now hiring Venue And Event Workers in Mount Laurel, NJ!  Apply today and you could start as soon as tomorrow. As a P…

View Details
Posted 2025-07-29

Cadd Operator

BP Human Resources
Edison, NJ

Job Description Job Description   CAD Operator: Full-time (Hourly) The candidate needed for this position with general supervision and proficiency will operate a CAD workstation, etc., to deve…

View Details
Posted 2025-07-28

Manager

Lornay II LLC
Hoboken, NJ

Job Description Job Description We are currently in search of a lead-by-example Restaurant Manager to join our team!   We are looking for an experienced and motivated Manager to join our tea…

View Details
Posted 2025-07-24

Credit Card and Credit Monitoring Editor, CNBC Select

NBCUniversal
Englewood Cliffs, NJ

NBCUniversal is one of the world's leading media and entertainment companies. We create world-class content, which we distribute across our portfolio of film, television, and streaming, and bring…

View Details
Posted 2025-08-05

Structural Engineer

CyberCoders
Chester, NJ

Job Description Job Description Structural Engineer Structural Engineer Position Overview We are seeking a skilled Project Designer - Structural Steel Detailer to join our dynamic team. Th…

View Details
Posted 2025-07-26