Director, Scientific Operations

Provides senior leadership and supervisory input for all aspects of research conduct and training at the Marcus Institute / HSL. Leads collaborations with faculty and the VP of Research and Administrative Operations to establish and maintain research protocol and training curricula consistent with regulatory guidance and contemporary standards for research ethics. Develop and maintains oversight procedures assuring compliance with ICH and GCP guidance for human subjects research, and other relevant standards as appropriate. Participates in protocol development and execution of specific research projects as appropriate. Acts as supervisor to skilled clinical and research staff and faculty, including Senior Project Director.

Position Responsibilities:
• Develop and maintain standards of research practice and compliance for Marcus Institute
• Develop and maintain training procedures consistent with internal and external regulatory guidance and clinical research standards
• Lead clinical projects as required including developing the clinical research strategy, supporting investigator and site selection, identifying, evaluating, selecting and managing site performance
• Provide consultative leadership on research design, protocol development, and regulatory compliance for Marcus centers and studies
• Other duties as assigned.

Qualifications:
• 10 years of experience in a junior to senior research project director role for large clinical studies, preferably multi-site investigations in older populations
• Advanced training (e.g. Master's, PhD) in nursing, epidemiology, psychology, or a related discipline
• Expert understanding of regulatory requirements in human subjects research; Certified in Good Clinical Practice; fluency with ICH guidelines, 12 CFR Part 11, FDA policy and other relevant regulatory requirements
• Experience in leading, training and verification of competency of junior and senior staff engaged in clinical research
• Solid knowledge and experience in state-of-the-art clinical research project management
• Soft skills: collaboration, independence, entrepreneurship, ambition, pragmatism, oral communication to scientific and lay audiences, excellence in English writing, multitasking and problem solving. Desire to participate as a leader in a growing biomedical research organization
• Outstanding organizational skills; ability to lead, take instruction and adapt to change
• Independent thought and ability to execute and share ideas with confidence

Hebrew SeniorLife requires all employees to be fully vaccinated against COVID-19 as a condition of their employment. All new hires must be fully vaccinated, which includes any recommended COVID-19 boosters, before their start date. Any exemption requests for medical or religious reasons will be considered on a case by case basis and must be processed prior to any start date.

Hebrew SeniorLife is an equal employment opportunity employer. All employment decisions are based on merit, qualifications, and competence and not influenced or affected by race, color, religion, age, gender, national origin, ancestry, marital status, military status, veterans status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by federal, state, or local law.