Associate Director, Clinical Operations

OVID Therapeutics

Ovid Therapeutics (NASDAQ: OVID) is a New York-based biopharmaceutical company using its BoldMedicine™ approach to develop medicines that transform the lives of patients with rare neurological disorders. Ovid has a broad pipeline of potential first-in-class medicines. The company's lead investigational medicine, OV101, is currently in development for the treatment of Angelman syndrome and Fragile X syndrome. Ovid is also developing OV935/TAK-935 in collaboration with Takeda Pharmaceutical Company Limited for the treatment of rare developmental and epileptic encephalopathies (DEE).

POSITION

The Associate Director, Clinical Operations supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate

RESPONSIBILITIES

• Performs as an integrated member of the clinical team to lead, direct and contribute to, the planning, execution, and reporting of clinical trials, including estimation of clinical project timelines, protocol writing, Case Report Form (CRF) design, site selection, study drug forecasting, site and Clinical Research Organization (CRO) management, data review, and study reporting; recommends monitoring, safety, eligibility, enrollment, and data consistency strategies
• Interacts with external and internal project team members to assist in the development of clinical strategies, trial design, study plans, and project deliverables
• meets with investigators and scientific and clinical staff to obtain direction and feedback.
• Assists in the evaluation of scientific literature and investigator advice regarding current clinical practice as a component of clinical strategy and protocol development
• writes, reviews and/or edits study protocols, protocol amendments, study manuals, informed consent forms, and related documents
• Prepares investigational site lists and participates in the review and approval of investigational sites
• negotiates contracts and budgets with sites and vendors and presents to the project team for approval
• plans, coordinates, and conducts investigator meetings including presentations at the meetings; responds to questions from sites and trial monitors regarding trial conduct
• Manages clinical study timelines using the appropriate project management tools; develops budgets and manages expenditures for clinical trial program, including those for investigational sites and vendors
• presents project progress reports through accurate, succinct summaries of clinical study work at internal team meetings and investigator meetings
• Provides on-going review of clinical trial data to ensure timely, consistent, and accurate data; assists in the interpretation of clinical data in preparation for clinical study reports and regulatory submissions

REQUIREMENTS:

• BA/BS degree in a scientific discipline
• Minimum of 7+ years progressively responsible US and/or global experience in clinical research in a pharmaceutical, biotechnology, CRO, university medical center or related environment
• Minimum 8+ years experience in Clinical Operations in biotech and pharmaceutical industry
• Comprehensive working knowledge of the drug developmental process
• Multiple Phase III and global clinical trials experienced
• Working knowledge of clinical trial design, conduct, data acquisition, and reporting
• Ability to recognize safety and efficacy trends of clinical data
• Hands-on experience supporting and understanding GCP, ICH guidelines
• Ability to influence without direct authority
• Proficiency with Microsoft Word and Excel
• Excellent verbal and written communication skills
• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changin priorities and deadlines
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects

PREFERRED QUALIFICATIONS:

• Rare Disease or CNS experience highly preferred

*Equal Opportunity Employer/Veterans/Individuals w/Disabilities

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