Medical Monitor Consultant

General Scope and Summary
SAGE Therapeutics is seeking a highly skilled and experienced Medical Monitor Consultant to join our Clinical Development team. This consultant will provide critical medical oversight for ongoing and upcoming clinical trials, ensuring the safety and well-being of study participants, and will play a pivotal role in monitoring study data. The ideal candidate will have extensive experience in clinical trials, particularly in the areas of medical monitoring and clinical data interpretation. This role requires a detail-oriented, self-motivated professional with a strong clinical background and the ability to collaborate effectively with cross-functional teams, CROs, and external partners.

Roles and Responsibilities

• Provide medical oversight and monitoring of ongoing clinical trials, ensuring participant safety and adherence to study protocols.

• Lead the review of clinical trial data, identifying potential issues and making recommendations for study adjustments as necessary.

• Collaborate with clinical operations, data management, and external partners to ensure the quality and integrity of study data.

• Support the preparation and review of clinical trial documents, including protocols, investigator brochures, and informed consent forms.

• Participate in medical review of clinical trial data and contribute to study execution processes.

• Support the development of regulatory submissions related to clinical trial data, including clinical study reports and other documentation.

• Engage with clinical study sites, investigators, and external stakeholders to provide medical expertise and guidance.

• Actively contribute to discussions on study strategy, protocol amendments, and risk mitigation strategies.

• Ensure the timely resolution of clinical and data-related issues, including escalation to appropriate stakeholders.

• Collaborate with other medical monitors and clinical team members to ensure consistency and quality across studies.

Experience, Education, and Specialized Knowledge and Skills
The ideal candidate for this role will have a solid understanding of medical monitoring and clinical trial oversight. They must demonstrate a deep knowledge of the clinical development process and have experience working across Phase I-IV clinical trials. The candidate should be adept at working in a collaborative, fast-paced environment and be able to navigate complex clinical and regulatory issues effectively.

Specific requirements include:

• Medical degree (MD, DO, or equivalent) with 3-5+ years of experience in medical monitoring of clinical trials in the pharmaceutical or biotech industry.

• Strong knowledge of clinical trial protocols, regulatory requirements (FDA, EMA, ICH-GCP), and the drug development process.

• Experience with CNS disorders (Neurology, Psychiatry, Anesthesia) is highly desirable.

• Proven ability to work independently and manage multiple projects simultaneously in a dynamic and evolving environment.

• Excellent communication skills, both verbal and written, with the ability to present complex clinical data clearly and persuasively.

• Strong interpersonal skills with the ability to build productive relationships with internal and external stakeholders, including investigators, CROs, and regulatory bodies.

• Strong analytical skills, with an ability to review and interpret clinical trial data.

• Highly motivated, results-oriented, and flexible, with a proactive approach to problem-solving and decision-making.

• Ability to collaborate in a cross-functional team environment, ensuring the highest standards of clinical trial integrity.

• Familiarity with electronic data capture (EDC) systems and clinical trial management tools is a plus.

• Ability to think critically and act decisively in the management of clinical trials.

• Strong attention to detail and a commitment to quality in all aspects of medical monitoring.

• Ability to collaborate and work effectively with teams across various departments, including clinical operations, regulatory affairs, and data management.

• A passion for improving patient outcomes and advancing clinical research.

• Flexibility and adaptability to thrive in a fast-paced, start-up environment.

• Embrace our Core Values: Put People First, Improve Lives, Cultivate Curiosity, Do Right, and Forge New Pathways.

• Excitement about the vision and mission of Sage.

Employment Type:

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Equal Opportunity Employer. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.

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We value our relationships with professional recruitment firms. To protect the interests of all parties, and given the large volume of inquiries received from third-party placement agencies, we are not able to respond to all agency inquiries. We do not accept unsolicited resumes from any source other than directly from candidates for current or future positions. Submission of unsolicited resumes in advance of a signed agreement between our company and a placement agency does not create an implied obligation and, if an unsolicited candidate represented by a placement agency is hired, we are not obligated to pay a fee. Only approved recruitment firms will be allowed to provide services to Sage Therapeutics, Inc.