Become An Ovidian
Ovid Therapeutics 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 Therapeutics 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 Therapeutics 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
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 Therapeutics 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 Therapeutics 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 Therapeutics, 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!
Responsible for executing functions of Ovid’s Quality Management System at the direction of the Quality Assurance Associate Director. These responsibilities include, but are not limited to:
- Review and approval (as applicable) of: batch records, analytical data, investigations/deviations, corrective and preventive actions (CAPA), change management, complaints and specifications.
- Provide input/information for internal or external audits and regulatory inspections.
- Participate in training activities that may include providing information to trainers or actual instruction for trainees.
- Participate in Pre-Approval Inspection (PAI) readiness activities.
- Support and provide back up to the document and training coordinator as needed.
- Provide support for annual quality and product reviews related to internal and external deviations; CAPAs; and associated change management as required.
- Draft/author deviation, CAPA, and other quality documents as applicable and follow through to completion.
- Participate in the material review board process.
- Represent QA to assure that applicable internal departments are informed of issues related to any deviations, investigations, CAPAs and change management.
- Support client/partner audits or regulatory inspections related to Quality Management, Manufacturing, Materials, and Packaging/Labeling Systems.
- Assist in the oversight of Manufacturing, Materials Management and Packaging/Labeling Systems. This includes applicable quality activities at Contract Manufacturing Organizations of Drug Substance (DS), Drug Product (DP) and testing facilities.
- This position may require minimal travel; no more than 10 percent.
- Bachelor’s Degree in Biology, Chemistry, Pharmacy, related science or equivalent skills and work experience.
- Minimum five years of experience in a current Good Manufacturing Practices regulated environment (e.g., pharmaceutical, medical device, etc.).
- Prior experience in the following areas required:
- Quality Management System functions used in the manufacture of GMP products (e.g. Change Management, Incidents, Deviations, CAPAs, Complaints).
- Working with external suppliers to address issues related to the Quality Management System functions including: Deviation/OOS investigations, Change Requests, Specification changes, etc.
- Collaborating with all levels of a company’s organization.
- Performing internal/external audits and participating in regulatory inspections.
- Review of documentation related to Quality Management System, Packaging and Labeling.
- Electronic Quality Document Management Systems and working within a virtual pharmaceutical company.
*Equal Opportunity Employer/Veterans/Individuals w/DisabilitiesAPPLY FOR THIS POSITION
SUMMARY: The Director of CMC is accountable for Manufacturing and Development efforts in leading the development of clinical through commercialization processes for API and Drug Product Manufacturing, Packaging, Labeling and Logistics. This position reports to the SVP of Regulatory, CMC & QA.
Assertive “hands-on” CMC, working with Contract Manufacturing Organizations (CMOs) to develop production plans and provide technical support while ensuring timelines for clinical and commercialization efforts are met.
Direct and manage the clinical supplies and logistics for Ovid in collaboration with Ovid Clinical Operations Team, CROs and CMOs for domestic and international trials. Including but not limited to: packaging configuration; labeling and label translation oversight.
Work with CMOs in developing Manufacturing Processes and Analytical Methods.
Provide recommendations, reviews and approvals of protocols, processes, batch records, stability studies and final reports.
Participate in PAI Readiness activities.
Act as Manufacturing Subject Matter Expert (SME) during regulatory inspections.
Review investigations, change controls and CAPAs associated with manufacturing activities of Ovid products.
Oversee and approve technical transfer of Ovid methods and processes.
Support GMP efforts to ensure alignment with Regulatory requirements.
Develop and negotiate Supply Agreements with CMOs for Ovid products.
Oversee process validation where applicable.
Develop or revise SOPs applicable to CMC by working with QA and Regulatory to ensure company policies are adhered to.
Oversee CMOs comply with Ovid company policies and regulatory requirements.
Prepare CMC regulatory filing sections (domestic and international) working with Regulatory and Quality.
Establish CMC reports and provide updates to Senior Management.
Minimum Bachelor’s degree in Chemistry or related Science. Advanced degree preferred.
Minimum 10 years hands-on CMC and management experience with focus on manufacturing/quality/clinical from development through commercialization in the Pharmaceutical industry.
Experience with oral solid and liquid dosage forms.
Direct experience effectively managing API and Drug Product CMOs.
Significant knowledge of GMP and FDA regulations related to CMC.
Proficient in authoring and preparing CMC documentation for regulatory submissions.
Strong knowledge of Clinical trials supplies management.
Excellent interpersonal communication skills and be highly collaborative when interacting within and outside the organization.
Demonstrated personal leadership and ability to effectively direct multiple projects with positive results within project timelines.
May require both international and domestic travel, up to 15 percent.
*Equal Opportunity Employer/Veterans/Individuals w/DisabilitiesAPPLY FOR THIS POSITION
POSITION: Regulatory Liaison
The Regulatory Liaison will be a Regulatory member of our core development team. He/she will be mentored by senior regulatory professionals to become proficient in the interactions with US and RoW health authorities and working in cross-functional development teams.
- Assist in development of global regulatory strategies to ensure high likelihood of success of submissions/approvals
- Help liaise and assist with global regulatory authorities to manage day-to-day communications and operations
- Contribute to the clinical development plans and regulatory strategic plans, to the project team
- Assist the preparation of regulatory submissions including pre-IND and formal meeting requests with FDA, Annual reports and routine correspondence
- Assist in the planning, coordination and preparation for meetings and teleconferences with regulatory authorities
- Monitor and oversees clinical trial activities for regulatory compliance and practices
- Assist in providing regulatory intelligence for cross-functional project teams
- Assist in regulatory review, feedback and /or approval for relevant documents.
- Provide regulatory support and guidance to cross-functional project teams for regulatory issues and questions and ensure that regulatory requirements are addressed
- Interact with company partners and consultants for various regulatory matters as needed
- Coordinate timely submissions to FDA and other health authorities
- Assist with logging, tracking and filing of correspondence and submission to/from regulatory authorities
- Prepare and writes regulatory documents for submissions
- Monitor applicable current and new regulatory requirements
- Help to prepare plan and internal SOP’s to manage regulatory compliance and reporting requirements.
- Bachelors plus Masters degrees in relevant field and at least 3 years of overall experience in the pharmaceutical industry. Advanced degree (PhD, PharmD) is a plus.
- Good working knowledge of FDA regulatory requirements and IND applications, experience in Pharmacovigilance is a plus
- Experience with multiple Health Authorities (FDA, EMA, PMDA) interactions and Scientific Advice proceedings
- Ability to assume accountability for a project goal/objective
- Experience working in cross-functional teams, participating in team discussions to resolve and reach agreement on project issues
- Excellent written and oral communication skills
- Knowledge in CNS disease area and Orphan Diseases is preferred
- Travel: Approximately 10% domestic and international travel for meetings with health authorities and conferences
POSITION: Regional Medical Scientific Director (RMSD), Associate Director/Director
The RMSD role requires an ability to translate complex scientific information and data into high-quality medical discussions The RMSD will establish and build peer to peer relationships with Therapeutic Area Experts, patient advocacy leadership and other scientific/medical experts (TAEs). The RMSD will be responsible for providing approved medical content on Ovid’s therapeutic areas of interest in rare neurodevelopmental disorders and rare epilepsies. The RMSD has the opportunity to enhance medical understanding via two-way discussions, support clinical development programs, enable collaborations between TAEs s) and key internal stakeholders. The RMSD will identify, collect and communicate key customer insights to internal teams.
Key activities and responsibilities include: Exchanging medical and scientific data with key TAE’s. Deliver scientific presentations and develop medical education initiatives to meet the needs of internal and external medical stakeholders. Identify gaps in medical knowledge of rare neurological developmental disorders and rare epilepsies and support the development of publication and educational efforts with TAEs to meet these needs. Support clinical trial activities by interacting with investigators, assisting in site identification and feasibility. Participate in reviews of investigator-initiated proposals. Respond to unsolicited requests for information from physicians in accordance with local laws, regulations, codes and Ovid’s SOPs. Participate in cross-functional teams, providing medical support and input as needed. This role will be an approximate 40/60% split between in-house and field medical responsibilities.
- Provide truthful, accurate and scientifically supported information in response to direct unsolicited medical requests from TAEs in a compliant manner.
- Provide therapeutic area/product expertise for other Medical Science and/or clinical development activities to include formulary presentations, speaker training, organized customer projects/collaborations, scientific congress participation, investigator interactions, etc.
- Identify gaps and implement publication and education strategies for designated customers.
- Keep current of medical and scientific developments in the designated therapeutic area by continuously reviewing literature in the field, monitoring competitor activities, networking with experts and attending assigned conferences.
- Maintain effective communication and collaboration among internal stakeholders.
- Ensure compliance with all internal/external SOPs/Rules/Regulations.
- Serve as a conduit and resource for customer insights pertaining to disease areas Ovid’s area therapeutic interests.
- Serve as conduit and medical resource to therapeutic area investigators and researchers, as appropriate.
- Contribute to the medical planning for brand/asset team projects and activities, and work with medical leadership to develop and implement the RMSD medical plan for Ovid’s area of therapeutic interests.
- Engage in scientific discussions both in the field and in-house teams to facilitate ongoing information/clinical data sharing such as new data, competitive information, insights learned from customer.
- Execute conference strategy, including staffing of scientific booths at major conferences and regional clinical meetings
- Support planning and execution of advisory boards.
- Facilitate the development of investigator-initiated studies, and publications and field activities associated with both lifecycle management and pipeline.
- This position requires approximately 60% travel (US and EU).
- Advanced scientific degree (MD, PhD, PharmD, NP) or equivalent experience.
- Minimum of 2 year’s experience in the pharmaceutical industry or other healthcare environment required.
- Previous experience in the field of Neuroscience or rare disease preferred.
- Previous experience in a field based RMSD role preferred.
- Thorough understanding of FDA, OIG, HIPAA and other ethical guidelines, laws, and regulations relevant to the pharmaceutical industry.
- Solid interpersonal communication and presentation skills.
- Ability to network and partner with key customers, including thought leaders and medical directors.
- Must be a strong team player and effectively collaborate with internal departments.
- Working knowledge of MS Office suite and associated hardware required.
- Candidate must have a valid driver’s license.
- Travel requirements: 60%.
*Equal Opportunity Employer/Veterans/Individuals w/Disabilities*APPLY FOR THIS POSITION
Position – Associate Director Clinical Director, Neurology
Ovid seeks a Associate Director Clinical Development, Neurology to leverage both strategic and scientific insights to provide support for many clinical activities, building clinical expertise in neurology and rare disease of the brain (currently rare epilepsies, Angelman and Fragile X Syndrome).
- Develop partnerships cross functionally, and with our external Partners; collaborate with others to write protocols and present data in a concise, consistent, and compelling manner.
- Contribute to the creation and maintenance of clinical development plans ultimately leading to critical decision points for our key trials.
- Report to the Program Leader/MD, and collaborate with clinical monitors, clinical operations, program management, regulatory, pharmacovigilance, etc.
- Leverage his/her comprehensive understanding of the drug development process in early and later stage development (currently programs in early stage – Phase I and II).
- Contribute to the clinical strategy and creation of the clinical development plans.
- Work as part of an integrated team.
- Provide support to advisory boards, consultant meetings and investigator meetings (including preparation and delivery of presentations).
- Collaborate with the clinical development team on the review, analysis, and interpretation of data.
- This is typically a role best suited for a PhD or PharmD, or equivalent with clinical research experience and a strong knowledge of drug development.
- 5-7 years of technical operational experience in planning, executing, reporting and publishing clinical studies.
- Possess a strong scientific background with industry clinical research experience. Work closely with regulatory affairs.
- Possess strong analytical and strategic thinking skills.
- Hold a record of partnering closely with medical monitors, clinical operations, and clinical investigators.
*Equal Opportunity Employer/Veterans/Individuals w/Disabilities*
APPLY FOR THIS POSITION