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

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.