Clinical Operations (AD, Director, Sr Director)

Clinical Operations Professional

Ovid Therapeutics Inc. is a New York-based biopharmaceutical company dedicated to developing small molecule medicines for brain conditions and symptoms caused by excess neural excitability. The role on our team we are seeking an experienced Clinical Operations professional in New York City, Philadelphia, or Boston area for our trials spanning early to late-stage clinical development. Your role will be responsible for overseeing and managing all aspects of clinical operations for a high priority program. This individual possesses clinical operations expertise with a track record of success, working with peers and stakeholders working cross functionally with Clinical Development, Regulatory, Non Clinical and other internal functions to develop operationally feasible and clear protocol concepts and final protocols, and will independently oversee one or more clinical studies by establishing the operational strategy and securing excellence in execution through external partners to drive programs with multiple studies and indications through all phases of clinical trials (Phase I-III). This role will be a leader in the organization who knows how to manage a team internally, at our clinical sites and with our vendors.

Key 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 Organization (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
• May also be responsible for contributing to a clinical development plan within a program moving into a new or subdivision of a current indication
• 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
• Develop operational strategy along with CRO/vendors aligned with the program strategy and incorporating local and country-level input
• Lead and oversee the strategic planning, implementation and execution of clinical trials across key programs in accordance with project timelines, budget, and quality standards
• Develop and manage comprehensive program project plans, including but not limited to, study protocols, clinical trial budgets, timelines, enrollment and risk mitigation strategies
• Collaborate cross functionally with internal teams, including Clinical Development, Regulatory Affairs, Biostatistics, Translational Medicine and Program Leadership to ensure alignment on clinical trial objectives and milestones
• Provide operational expertise and strategic input into the development of Clinical Development Plans (CDP), supporting the overall clinical strategy for the program
• Serve as the point of contact for CROs and vendors, overseeing their performance and ensuring adherence to contractual agreements, timelines and quality standards
• Ensure compliance with regulatory requirements, ICH-GCP requirements, and company SOPs throughout all stages of clinical trial conduct
• Oversee the collection, analysis and interpretation of clinical trial data, working closely with Clinical Development, Biostatistics and Data Management teams to ensure data accuracy and integrity
• 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

Your 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.

Your 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

Ovid operates in a hybrid-work model. Candidates applying must be willing and able to be in the NYC office in coordination with their manager's expectations, as well as department and business needs. The base salary range for this position is $200,000-270,000. The 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.