Bachelor's degree in life sciences or health-related field; advanced degree preferred (Masters, PharmD, PhD, or MD).
8+ years of industry experience in both pre-clinical and clinical research.
Expertise in hematology is essential.
Advanced skills in program-specific data review and trend identification.
Familiarity with ICH, GCP, and relevant regulatory guidelines.
Strong written communication and analytical skills.
Proven ability to collaborate effectively with medical experts.
Responsibilities
Develop program strategy for assigned trials and compounds.
Author and review clinical and regulatory documents with the Medical Director.
Support the development of eCRFs and data management deliverables.
Lead medical data review and summarize efficacy and safety data.
Assist in country/site selection and engage with KOLs.
Coordinate internal/external committee meetings and prepare presentations.
Participate in study plan development and liaise with project teams.
Contribute to publication development with the Scientific Communications department.
Benefits
100% paid employee premiums for medical, dental, and vision insurance.
Short-term and long-term disability coverage.
401(k) plan with 50% company match up to 3% and a 5-year vesting schedule.
15 PTO days per year plus sick leave.
11 paid holidays annually.
Full Job Description
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 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.
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.
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.
