Senior Director, Immuno-Oncology Clinical Science

SystImmune, Inc.; Princeton (NJ); Presencial; USD 180 000 - 240 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

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

Resumo da oferta

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.

Qualificações

• 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.

Responsabilidades

• 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.

Conhecimentos

ICH & GCP knowledge

Clinical data interpretation

Data review & trend analysis

Regulatory collaboration

Communication & presentation

KOL engagement

Formação académica

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

Descrição da oferta de emprego

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.