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 Quality Assurance Manager is responsible for the oversight of activities related to Quality Systems, Material Systems, Laboratory Systems and Packaging/Labeling under the direction of the Associate Director, Regulatory, QA and CMC. The Manager will direct the pre-approval readiness process, pre- approval inspection and post approval analysis/review to assure corrective measures are established and implemented. Additionally, the incumbent will be empowered to provide recommendations and decision making for Quality Management Systems detailed above. The Associate Director, Regulatory, QA and CMC will delegate additional projects to the incumbent, as a lead or participant. Responsibilities of the incumbent may be delegated to direct reports as required.
- The incumbent will have the responsibility for day-to-day Quality Assurance oversight and management of compliance operations for Ovid with a concentration on on-going Pre-Approval- Inspections activity for API and Drug Products. Responsibilities include, but are not limited to, the following:
- Manage the Pre-Approval Inspection efforts for API and drug products to include drafting, review and/or approval policies, procedures, work instructions, plans, etc., related to API and DP.
- Review and approval of any change request associated with the policies, procedures, work instructions, plans, etc.
- Provide training on associated documents supporting PAI’s where required.
- Establish PAI plan to includes identification of documentation needed to support the approval efforts, establish timelines for completion and delegate where required.
- Coordinate PAI efforts with Associate Director, Regulatory, QA and CMC to ensure all areas required are covered under the plan.
- Provide periodic updates to management (Associate Director, Regulatory, QA and CMC) on the “plans” progression. Using metric evaluation, track the progression versus goal completion date.
- Communicate with Regulatory Agencies on issues that may arise during the PAI preparation period and post approval at the request of the Associate Director, Regulatory, QA and CMC.
- Maintain specifications through the Document Management System for in-process testing and finished product testing of DP and API, raw materials, starting materials and packaging components. Revise as necessary and report changes to regulatory agencies as required.
- Provide support for Annual Review / Annual Product Review as required.
- Represent Quality Assurance and Regulatory, as required, to assure that internal departments are informed and aware of issues related to PAI and other critical areas identified by the Associate Director, Regulatory, QA and CMC.
- Manage projects and prioritize team efforts to accomplish successful end result. Provide any risk assessment for issues and evaluate impact to the organization.
- Provide support for Batch Record Review as required.
- As needed/required, lead or support Client/Partner audits or Regulatory Inspections.
- Provide leadership on teams involved with the day to day management of OVID’s Quality Operations and Systems.
- Bachelor’s Degree or equivalent skills or work experience.
- A minimum of 10 years’ preferred experience in the pharmaceutical industry with related experience in Quality Assurance, Quality Control and Manufacturing.
- A minimum of 5 years supervisory, management or leadership role in the pharmaceutical industry.
- Experience working in domestic and international biopharmaceutical regulatory audits / regulatory inspections environments.
- Extensive knowledge of global GMP’s and QA/QC systems/practices.
- Past experience in managing complex quality and compliance activities in a turn-key manufacturing facility or contract provider.
- Must have excellent organizational skills and the ability to manage multiple projects and prioritize work efforts both individually and through others to accomplished expected results within required timelines.
- Ability to access risk in evaluating issues (hazards) and level of “harm” that may occur. Use risk assessment as a means of analyzing and making better decisions.
- Possess superior interpersonal communication skills when interacting within and outside the organization.
- Demonstrate leadership characteristics needed to successfully coordinate work and resolve any issues.
- Demonstrated oral and written communication skills including presentations to management and external organizations.
*Equal Opportunity Employer/Veterans/Individuals w/DisabilitiesAPPLY FOR THIS POSITION
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
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