Director of Clinical Science

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 companys success.

Responsibilities

• Contributes to developing the program strategy for assigned trials/compounds.
• Acts as a component author 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).
• Leads the development of a medical data review plan, medical monitoring plan, performs ongoing medical data review, and summarizes efficacy and safety data for interpretation/analysis.
• Provides input for country/site selection and feasibility assessment and interacts with KOLs.
• Prepares charters and coordinates internal/external committee meetings including presentations and discussion with senior leadership.
• Participates in the development and review of study plans and liaises with project teams.
• Prepares presentations for Investigator meetings, site personnel, CRA training, pre-study site visits (SEVs), and site initiation visits (SIVs).
• Provides input for developing publications in coordination with the Scientific Communications/Publishing department.

Qualifications

• Bachelors 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.

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