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Role Description

• Provide scientific and strategic leadership in the planning and execution of clinical trials, including protocol development, study design, and data analysis.
• Author and review clinical protocols, ICFs, CSRs and regulatory documents.
• Collaborate closely with cross-functional teams, including Clinical Operations, Regulatory Affairs, Biostatistics, and Medical Affairs, to ensure the successful conduct of clinical studies.
• Interpret clinical data, prepare study reports, and contribute to regulatory submissions and presentations for internal and external stakeholders.
• Support investigator meetings, advisory boards and data monitoring committee meetings.
• Stay current with emerging scientific literature, competitive landscape, and regulatory requirements relevant to Immuneering’s oncology therapeutic area.
• Support the development of clinical development plans and contribute to the strategic direction of ongoing and future programs.
• Work closely with CRO’s and have a can do, proactive biotech mindset.

Qualifications

• PhD, PharmD, RN, or MD in a relevant scientific discipline (e.g., biology, pharmacology, medicine).
• Minimum of 5-8 years of experience in clinical development within the pharmaceutical or biotechnology industry.
• Direct Phase 3 oncology clinical trial experience required.
• Demonstrate experience authoring and reviewing clinical documents.
• Demonstrated strong experience in clinical trial execution and data interpretation.
• Strong analytical, organizational, and communication skills.
• Deep understanding of oncology clinical development, endpoints and regulatory expectations.

Requirements

• Excellent cross-functional communication and stakeholder management.
• Ability to work collaboratively in a fast-paced, team-oriented environment.
• Must be a strong champion of our Values: All in, Data Rules, Care, Humble, Own It (Accountable).

Physical Demands/ Working Conditions

• Requires prolonged sitting, some bending, stooping, and stretching.
• Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment.
• Requires the ability to perform essential job functions with or without reasonable accommodation.
• No significant lifting is associated with the role.
• While extensive travel is not anticipated with this role, it is possible to perhaps up to 15% at times.
• Requires normal range of hearing and eyesight to record, prepare and communicate appropriate reports.

Company Description

Immuneering is an equal opportunity employer. We are committed to creating a diverse and inclusive workplace where all employees are treated with fairness and respect. We do not discriminate on the basis of race, ethnicity, color, religion, gender, sexual orientation, age, disability, or any other legally protected status. Our hiring decisions and employment practices are based solely on qualifications, merit, and business needs. We encourage individuals from all backgrounds to apply and join us in our mission.