Director of Clinical Science - ImmunoOncology

SystImmune, Inc.; Princeton (NJ); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

100% paid employee premiums for мед/​d

STD, LTD

401(k) plan with 50% company match of

15 PTO days per year

sick leave

11 paid holidays

Job summary

SystImmune, Inc. is a clinical-stage biopharmaceutical company seeking a senior professional to lead medical data strategy and regulatory documentation across trials. You will author critical regulatory components, develop data review processes, and support registration and commercialization of oncology programs.

The role requires a strong background in hematology, 8+ years in industry, and expertise in ICH/GCP guidelines. Collaboration with medical experts and senior leadership is essential.

Qualifications

• Bachelor’s degree in life sciences or health-related field with an advanced degree.
• 8+ years of industry experience including pre-clinical and clinical research.
• Hematology therapeutic expertise.
• Strong data review, trend identification, and data interpretation skills.
• Knowledge of ICH, GCP, and regulatory guidelines.
• Excellent written and verbal communication, and collaboration with medical experts.

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 to support registration and commercialization.
• Contributes to the development of eCRF and eCRF completion guidelines and provides scientific support for other data management deliverables.
• Lead the development of a medical data review plan, medical monitoring plan, and summarize efficacy and safety data.
• Provide input for country/site selection and feasibility assessment and interact with KOLs.
• Prepare charters and coordinate internal/external committee meetings including presentations 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, SEVs, and SIVs.
• Provide input for developing publications in coordination with Scientific Communications/Publishing.

Skills

ICH & GCP knowledge

Clinical data interpretation

Data review & trend analysis

Regulatory collaboration

Communication & presentation

KOL engagement

Education

Bachelor’s degree + advanced degree in life sciences/health

Job description

SystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Bothell, 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 eCRFsand eCRFs completion guidelines and providesscientific 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 supportprogram-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 $240,000 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.