Clinical Operations (AD, Director, Sr Director)

About the role

Ovid Therapeutics Inc. is a biopharmaceutical company focused on developing small molecule medicines for brain conditions and symptoms caused by excess neural excitability. We are seeking a Clinical Operations professional to manage clinical operations for high-priority programs.

Responsibilities and Impact

• Manage interactions with and between clinical monitors, biostatistics, medical writing, safety and other key stakeholders and effectively interact with scientists and managers within and outside Clinical Research Organizations (CRO), vendors, and partners. Have strong outsourcing experience.
• Provide program-level sponsor’s operational oversight of our strategic partners and other vendors to ensure the effective execution of the clinical studies on time, with high quality and within agreed budget.
• Develop and lead the program-level operational strategy and planning on assigned programs in close collaboration with our strategic partners and other vendors.
• Organize and lead study specific meetings.
• Develop scientifically robust, operationally feasible and clear protocol concepts and protocols, robust, data monitoring plans, and other study documents.
• Ensure compliance with regulatory requirements, ICH-GCP requirements, and company SOPs throughout all stages of clinical trial conduct.
• Contribute to the preparation and review of clinical study documents including the Investigator Brochure, Investigational New Drug Applications (IND), study protocols, clinical study reports, applicable sections of New Drug Applications (NDA) and or Marketing Authorization Application (MAA), updates to the IND, NDA and other safety reports.

Expertise - Minimum Requirements

• 10+ years of clinical research / project management experience, preferably with both a sponsor company and CRO managing outsourced clinical trials within quality, timeline, and budget expectations.
• Detailed understanding and experience in all aspects of clinical protocol development, implementation, regulatory submissions, and overall drug development.
• Ability to establish operational plans and support the CRO/vendor in the execution of the plans.
• Understanding of clinical development within two or more phases of trials (Phase I, II, III, IV) and a working understanding of cross-functional drug development.

Background and Experience - Preferred Qualifications

• Prior investigator site and/or monitoring experience is advantageous.
• Deep knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials and experience in the development of study designs is desirable.
• Adaptability, flexibility, independence, and resourcefulness to roll-up-sleeves and multi-task so to thrive in a small company, fast-paced environment.
• Marked proficiency in clinical and/or medical writing.
• Broad experience in early-stage and late-stage development programs.
• Demonstrated experience working with FDA, MHRA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies in the United States.
• Extensive knowledge of regulatory guidelines and experience with worldwide regulatory agencies in therapeutic product development; global experience highly preferred.
• Outstanding presentation, written and oral skills are required. A clear communicator who can influence effectively both internally and externally.
• Bring a history of great collaboration and teamwork with the ability to motivate and influence others; have a reputation for successful partnering with internal and external stakeholders.
• Have the ability and the drive to succeed in a small biotech organization. Interest to grow in the function to advance new technologies in new therapies. Must be self-motivated, proactive, work well under pressure and deadlines, and thrive in a small “all hands-on deck” environment.
• Solution-oriented thinker who possesses a “can do” attitude with a strong sense of urgency.
• Create a balance of analytical and methodical problem solving with creative and flexible solutions.

Qualifications

• PhD in a relevant field (e.g., pharmacology, medicine, biology) or equivalent combination of education and experience.
• Experience in clinical research, project management, and regulatory affairs.
• Strong leadership and interpersonal skills.
• Excellent communication and collaboration abilities.

Benefits

Base salary range for this position is $200,000 - $270,000. Actual salary offered within the range is dependent on a variety of factors including, but not limited to, relevant experience, qualifications, skills, level offered, and performance expectations.

Pay

The base salary range for this position is $200,000 - $270,000.

Schedule

This role is a hybrid of office visits in NYC, working from home, and traveling to our sites and for business meetings.