Become An Ovidian
Ovid is a culture of motion. Motion toward breakthrough and curiosity, motion that ignites an urgency to improve the lives of patients, families and caregivers, motion that develops the individual and propels us towards success.
Ovid is based in the heart of New York City with a satellite office in Cambridge, MA. We are in a growing life science ecosystem, which equips us with the resources and capabilities to better serve our patient communities. Ovid channels these cities’ vibrant energy, diverse people and entrepreneurial drive to advance with imagination, discipline and deep industry experience.
We courageously take on the innate challenges and opportunities of drug development for rare neurological disorders with responsibility, agility and passion.
What it means to be an Ovidian...
“I get up in the morning in order to make a difference for people, and especially to make a difference in people living with serious illness; that’s what drives me and why I love working in the biotech industry. My passion is for helping people reach their goals and be all that they can be.”
– Amit Rakhit,
Chief Medical & Portfolio Officer
“I have a passion to be the best I can be while making others around me successful. I love a team environment and the feeling we are making an impact. Do what you love and it is never considered work.”
– Tim Daly,
Vice President, Finance and Corporate Controller
“My boldness comes from challenging team members to envision how they would develop medicine from the perspective of never having done it before.”
– Joe Callender,
Associate Director, Project Management
Ovid’s Commitment to its Employees
Together, we will build a community that:
- Sees each employee as a business partner
- Is innovative and thought provoking
- Provides challenge
- Is constructed on collaboration
- Encourages transparency
- Builds value and depth
- And revels in fun and laughter
Curious & Imaginative.
WE ARE BOLD.
Become an Ovidian
Ovid Therapeutics Inc. is a New York-based, clinical-stage biopharmaceutical company committed to transforming the lives of patients with rare and orphan disorders of the brain.
While building upon our exceptional team, we aim to become a leading neurology company with multiple products and a rich pipeline, coupled with compelling research and development. Ovid was selected by BioSpace as one of the Top 20 Start-Ups to watch in the biotech sector. In May 2017, the company completed a successful initial public offering, raising $75 million to further advance the pipeline and business development activities.
Ovid Therapeutics is committed to providing equal employment and advancement opportunity to all applicants and employees. Every Ovidian has the right to work in an atmosphere which encourages mutual respect, free from improper discrimination and harassment of any kind. Therefore, our employment decisions are based on business need, job requirements and individual qualifications and abilities. Ovid does not discriminate in employment opportunities or practices on the basis of race, religion, color, sex, age, national origin, disability, genetic information, veteran status, marital status, sexual orientation, gender identity and/or expression, family or parental status or any other characteristic protected by applicable law.
For Ovid, this statement is more than equal opportunity it is about being BOLD. BOLD is a place where:
- who you are transcends what you are,
- varied beliefs and backgrounds makes for richer discussion, and
- diverse experience & thinking leads to innovative insights.
Join us and be BOLD!
The Director, Biostatistics will provide guidance and accountability for all statistical aspects of clinical studies and submissions, including quality, relevance and scientific validity to the regulatory & clinical organizations.
- Provide statistical leadership to program teams.
- Collaborate with clinical and regulatory teams to design strategic approach, draft clinical development plans (CDP) and individual protocols.
- Lead statistical analyses, preparation of the statistical methods and results sections for clinical study reports (CSR), and production of overall summaries.
- Review and approve key results and statistical conclusions.
- Provide guidance to the clinical and regulatory teams regarding conclusions and inferences from the data package.
- Serve as representative at regulatory and other external meetings.
- Maintain awareness of industry standards, regulatory requirements, departmental guidelines, and SOP’s. Update procedures and practices as needed to remain in compliance with external industry and internal SOP standards.
- Advocate application of statistical thinking across Ovid cross-functional decision-making. Develop collaborative and productive relationships with individuals across other functional teams.
- PhD in Biostatistics.
- Minimum 5 of years of hands-on biostatistics experience with at least 3 years in the biotech industry, including interactions with regulatory bodies.
- Experience in neuroscience or neurodevelopment a plus.
- 1-2 years of experience developing and managing working relationships with third parties, including, CRO’s, consultant and the research community.
- Working knowledge of data management, SAS, and regulatory submission standards.
- Excellent interpersonal, written, verbal and presentation communication skills.
- Comprehensive knowledge and superior understanding of advanced statistical concepts and techniques.
- Proven ability to innovatively apply technical principles, theories, and concepts to clinical development and the research & development lifecycle.
- Record of accomplishment in previous submissions and interactions, with regulatory bodies and/or involvement in development of regulatory guidelines and requirements for drug development.
- In-depth understanding of the regulatory drug submission/approval process in the US and globally.
- Ability to work in a self-directed manner.
- Ability to travel as needed (estimated less than 10% time).
*Equal Opportunity Employer/Veterans/Individuals w/Disabilities*
APPLY FOR THIS POSITION
The successful candidate will present with broad corporate experience including transactional work, general corporate housekeeping, securities including, regulatory and more. S/He will have experience in complex financing document management, SEC and FINRA filings, Board of Directors related work and general corporate matters. Strong analytical skills and the ability to draft, edit and review a wide range of legal documents are crucial for success in this position This individual will provide the Corporate Secretary’s Office with governance support utilizing advanced communication and organizational skills.
- Support activities related to board and committee meeting preparation including: drafting memoranda, maintaining compliance matrices and action logs, assembling materials, managing self-assessment process, and maintaining corporate records.
- Assist Corporate Secretary with drafting of board minutes and resolutions.
- Coordinate and distribute for signature various corporate governance documents including: conflicts of interest questionnaires and code of ethics attestations.
- Coordinate updating of board orientation materials on an annual basis.
- Support and assist with shareholder-related activities including: share redistribution and reallocation processes; annual shareholders meetings; coordination with relationship management, finance and other internal departments relating to shareholder matters.
- Coordinate minute book reviews for external auditors and regulatory bodies.
- Maintain internal corporate governance website.
- Maintain and assist with updating internal Corporate Secretary’s Office policies and procedures.
- Oversee the documentation and approval process for the formation, dissolution, and qualification of legal entities.
- Create and revise word documents – knowledge of track changes, and other advanced word skills necessary.
Knowledge & Skills:
- Knowledge of corporate governance matters and best practices.
- Basic understanding of governance documents such as: resolutions; written consents; minutes; bylaws; Secretary’s Certificates; agendas; and charters.
- Self-starter, with strong individual and project management skills and experience, who can work well both independently and in a team environment.
- Strong oral and written communication skills.
- Highly organized, able to prioritize and manage multiple tasks.
- Ability to work effectively and professionally under time deadlines and pressure.
- Detail orientation is critical, along with extensive experience in handling a variety of responsibilities requiring a high degree of focus.
- Previous exposure to working with senior executives and board members.
- Demonstrated ability to discretely handle highly sensitive and confidential information.
- Excellent interpersonal skills, initiative, dependability, and a high level of motivation
- NY notary a plus.
What You’ll Need to Succeed
- Bachelor degree is required; and a professional certification as a paralegal is preferred
- Minimum of six years relevant transactional or corporate paralegal experience; in-house corporate experience a plus.
- Proficiency in MS Office 365 (Excel, PowerPoint, OneDrive, Outlook, SharePoint etc.).
- Excellent organizational, planning and project management skills.
Reporting to the Vice President Global Clinical Operations, the Director Clinical Operations is accountable for the design and implementation of strategic, operational and people plans for the Clinical Operations organization, including long range planning to meet scalability, productivity goals and established metrics. As we continue to grow organizationally and advance our clinical development efforts, this role represents both a strategic and operational opportunity to lead, oversee and outsource day to day study operations to support Ovid and its clinical objectives.
- Co-develop and manage the Clinical Operations outsourcing strategy including RFP generation, negotiation, capabilities assessment, and selection. Obtain buy-in and promote its success.
- Develop relationships with key stakeholders internally and externally, including collaborators, vendors, investigators to advance efforts to ensure time, cost, quality and risk mitigation is embedded to the clinical trial process.
- Work collaboratively to agree upon processes, systems and procedures to lead Global Clinical Trial Management teams.
- Partner with Regulatory Affairs on protocol development and ensure efficient development of core clinical trial documentation (e.g., investigator brochures, informed consent documents, case report forms, statistical analysis plans, monitoring plans, data management plans, etc.).
- Ensure appropriate resourcing of skills, knowledge and experience are assigned to studies.
- Ensure compliance with SOPs, GCP and regulatory requirements for all clinical trials.
- Accountable for developing and managing the Clinical Operations budget.
- Oversee the day-to-day performance of CROs and other vendors.
- Drive data analysis, interpretation, and data representation for internal and external uses (e.g., presentations, abstracts, manuscripts).
- Participate in the development and review of SOPs and Clinical Operations systems.
- Travel as necessary (10-15%).
- Bachelor’s Degree with a minimum of 10 years of clinical research experience (Master’s Degree or PhD preferred).
- Minimum of 5+ years working in Clinical Operations. Experience in neurology or rare diseases is preferred.
- Strong understanding of the clinical and drug development process.
- Experience working with ICH Good Clinical Practices, Clinical Safety Data Management, clinical trials management (including protocol design, data management, site monitoring, statistical reporting, report writing), regulatory compliance and auditing.
Associate Director/Director Communications: Medical Writing and Publications
Primary duties will encompass management of company-wide writing resource and publication activities. The Director Communications: Medical Writing and Publications prepares (researches, writes and edits) and manages the resources assigned to clinical, nonclinical, and regulatory documents according to applicable regulations. Clinical documents include protocols, Investigator’s Brochures, consent forms, annual reports, clinical study reports, regulatory briefing documents, and clinical sections of IND’s, NDA’s, and other regulatory submission documents. In addition, this role will manage and prepare (researches, writes and edits) abstracts, posters, presentations, manuscripts, and patient education materials.
Engages cross functional team to prepare publication strategy and implement plan under strict timelines
Helps position and maintain Medical Writing and Publications as a strategic partner with functions throughout the lifecycle of a project
Roles and Responsibilities – Medical Writing and Publications
- Provides senior oversight of document preparation, quality and consistency. Ensures efficient formatting of documents; ensures a consistent style of presentation to maintain quality and ease of review across multiple documents assembled in a regulatory dossier and briefing package / book and other documents (manuscripts, abstracts etc.)
- Develop publication strategy aligned with medical strategies and communication objectives. Revise publication plan as needed and coordinate review and approval of publication plan and tactics
- Maintain strategic publication plan and input in PubSTRAT
- Oversees and implements publication plan project management and maintenance of documents in PubSTRAT. Responsible for consistency, accuracy, and currency of documentation in PubSTRAT
- Leads overall medical writing preparation, project management and aligns with cross functional working groups to facilitate efficient development and finalization of clinical, nonclinical and regulatory documents for submissions
- Coordinates and lead discussions within cross-functional Core Communications Team and/or Joint Publication Team (alliance partner) to ensure strategic and implementation excellence
- Leads and coordinates meetings to discuss conflicting comments on manuscripts
- Plans and manages Medical Writing resource (FTE and/or contractor resource), which includes assignment of the appropriate level of medical writing support to the right team at the right time, in close collaboration with other development functions to ensure implementation of publication plan
- Ensures development of publications complies with Ovid publication policy
- Manages publications budget
- Manages medical communications agency on deliverables, as needed
- Must be knowledgeable and able to prepare documents in ICH, CTD and CFR formats and knowledgeable of electronic submission formatting (eCTD)
- Excellent writing skills for professional and patient education materials and able to write medical documents independently
- Perform medical literature research and interpret medical literature independently
- Knowledge of medicine and disease states
- Strong familiarity with medical terminology
- Prioritize multiple tasks and transition between activities depending upon corporate needs
- Proficiency in Microsoft Word, Outlook, Microsoft Excel
- Excellent organizational skills and attention to detail
- Perform all essential job functions under the constraint of tight timelines
- Flexibility in meeting the changing demands of each project
- Demonstrated ability to communicate and write English clearly, concisely, and effectively
- Well-organized: ability to prioritize tasks, work simultaneously on multiple projects, and complete high-quality documents according to tight timelines
- Working knowledge of drug / biologics development, clinical research, study design, biostatistics, the regulatory environment, and medical terminology preferred
- Detailed knowledge of requirements for preparation of key clinical, nonclinical and regulatory documents and annual reports is a plus
- Recent and significant experience in writing of regulatory documents such as Clinical Study Reports, Protocols, Summaries, Overviews
- Accurate and detail-oriented
- Aptitude for compilation, analysis, and presentation of data
- Independently motivated with good problem-solving ability
- Ability to work with multiple contributors to produce a final unified document
- Enjoys a cohesive, motivated team-oriented work environment
*Master of Science Degree in a life science field. NP qualification, PharmD, RPh, preferred and a minimum of 5-10 years in the pharmaceutical industry and 5 years of experience as a medical writer, or in a management position in a pharmaceutical industry environment is required.APPLY FOR THIS POSITION