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

Ovidians embrace the balance of...

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

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Joyful.

Groundbreaking.

Curious & Imaginative.

Collaborators.

Diverse.

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!

 

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The Position

The Associate Director (AD) of Quality Systems is responsible for the oversight, and when needed, performing  activities as related to the functions within the Quality Systems. The AD will direct and manage the  Quality System resources and workflow to successfully achieve pre-approval readiness at Ovid. Post PAI, the AD  will be responsible for the development and implementation of effective corrective measures related to any PAI observations. This position will be empowered to provide recommendations and decision making for Quality System functions outlined below.  This position reports to the Director, of Quality Assurance Management Systems and CMC. The Director, QA and CMC will oversee the responsibilities of the AD listed below and may delegate additional projects and activities as required. Responsibilities of the AD may be delegated to direct reports as appropriate.

Responsibilities

  1. The AD will have the responsibility for oversight and management of direct reports who perform day-to-day activities related to Quality Systems compliance for Initial concentration will be on Pre-Approval Inspection readiness. Responsibilities may include, but are not limited to, the following:
    • Pre-Approval Inspection efforts for DS and DP products to include drafting, review and/or approval policies, procedures, work instructions, plans, , maintained in Ovid’s Quality Management System (QMS) to include but not limited to: Audits, Validation, Change, Risk and Deviation Management, Corrective and Preventive Action (CAPA) processes, Complaints, Batch Record Review, Investigation and Release, Analytical Review, OOS, and Stability.
    • Provide training on associated processes where
    • Provide periodic updates to Director, QA and CMC on PAI/plan progression. Using metric evaluation, track the progression versus goal completion
  2. Implement GMP documentation for the specified Quality System functions with the approval of Director, QA and
  3. Manage risk assessments, evaluate impact and report risks to the organization, according to company policies and procedures.
  4. Manage the Master and Production Batch Record Review process, assuring timely and accurate investigations for release of DS and DP, as required.
  5. Evaluate stability data and assess for trends. Assure all reports are reviewed by the appropriate Ovid staff.
  6. Provide data and associated trend analysis for Annual Review / Annual Product Review as
  7. Maintain specifications for raw materials, starting materials, DS, DP, and all packaging components. Revise as necessary and report changes to Ovid regulatory as
  8. Notify internal departments of issues related to PAI or other critical areas having impact on Ovid Quality Systems. Escalate issues to Sr. Management as required.
  9. Manage, lead or support supplier/Partner audits or Regulatory
  10. Provide leadership to direct reports responsible for day to day management of OVID’s Quality Systems.
  11. Able to travel domestically and International as required.

Qualifications

  • Bachelor’s Degree or equivalent skills and work
  • A minimum of 10 years’ experience (preferred) in the pharmaceutical industry with extensive knowledge in Quality Assurance, Quality Control and Manufacturing.
  • 3 years+ of managing in a leadership role.
  • Experience working in domestic and international regulatory audits / regulatory inspections
  • Extensive knowledge of GMP’s and QA/QC systems/practices.
  • Prior experience managing complex quality and compliance activities in a manufacturing facility or Contract Management Organization. Experience working in a virtual company is a plus.
  • Must have excellent organizational skills, attention to detail, and the ability to manage multiple projects to meet expected timelines.
  • Ability to assess risk in evaluating issues and level of impact. Use risk assessment as a means of analyzing in the decision process.
  • Possess superior communication skills when interacting within and outside the organization.
  • Ability to provide presentations to management and external

*Equal Opportunity Employer/Veterans/Individuals w/Disabilities

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The Position

Ovid is seeking a “hands-on” Medical Director, who as a strategic partner to the Vice President, Clinical Development, Epilepsies and team, will develop, lead, and help drive the clinical development strategy of Ovid’s clinical pipeline. The Medical Director, Clinical Development will help provide the vision, leadership, strategy and general management skills to lead the company’s clinical development epilepsy programs, as well as participate in strategic aspects of drug development. The requirements for the position include an MD from an outstanding institution and solid grounding in the pharmaceutical and/or biotechnology industry. The ideal candidate will be an experienced clinician with an outstanding record of accomplishment in successfully leading clinical development activities.

The Medical Director, Clinical Development will serve as a key member of management and will also be expected to participate actively in strategic planning, partnering discussions, and presentations to the executive committee. Significant early (and preferably late-stage) clinical development experience is required and successful registration experience is highly preferred.

 Primary Responsibilities

  • Provide key role and ongoing perspective to the company’s clinical development strategy. Working closely with the Vice President, Clinical Development and team, assume all aspects of clinical development, including indication strategy, design and conduct of clinical trials, selection of clinical trial sites, selection and training of physicians, selection and management of CROs and oversight, analysis and interpretation of clinical data.
  • Execute the rare disease clinical programs as well as provide strategic input and execution of new clinical programs.
  • Provide medical oversight to ensure the highest data quality from clinical studies.
  • Provide medical review, assessment and interpretation of all clinical data reported in clinical study reports to ensure that the data is presented with the appropriate medical interpretation.
  • Assume responsibility for meeting Ovid’s program clinical milestones, working closely with Ovid’s R&D team, Scientific Advisory Board, and consultants to assure timely filing of all clinical applications.
  • Represent Ovid’s clinical data and strategy with potential strategic partners and licensors and participate in due diligence activities as required.
  • Maintain understanding of competitor programs and clinical developments in relevant therapeutic areas and engage KOLs and consultants as required.
  • In collaboration with Ovid Clinical Development leadership, serve as a clinical face of the company both internally and externally, including the scientific community and key opinion leaders.
  • Actively assist in seeking product and/or technology alliances with appropriate pharmaceutical company partners to enhance/expedite the development of the company’s assets.
  • Recruit, supervise, and mentor all direct reports. Help to attract and retain a top-notch clinical development team.

 Professional Experience and Requirements

The ideal candidate is a clinician with early to late stage drug development experience with experience in the biotech or pharmaceutical industry and broad-based experience in clinical research. A record of accomplishment, including developing, planning, directing and designing clinical studies and clinical development programs leading to successful registration of products is desirable; experience with registration trials is preferred. A history of successful development of compounds for the treatment of neurological disorders is highly desired.

Qualifications include

  • Demonstrated success in developing therapeutics through the stages of clinical development towards global regulatory approval.
  • Thorough understanding of the drug development process and awareness of requirements and issues related to the development of therapeutics.
  • Experience in developing, planning, directing, designing and implementing all phases of clinical studies is ideal.
  • Extensive knowledge of regulatory guidelines and experience with worldwide regulatory agencies in therapeutic product development; experience interacting with the FDA and taking products through registration level testing.
  • A comprehensive network within the pharmaceutical and biotechnology industry; the ability to reach key thought leaders in academia & companies which are likely prospects for collaborations & licensing relationships.
  • Hands-on, proven ability to work in a small environment, with the ability to manage and outsource work as required.
  • Dynamic, highly motivated self-starter with strong executive presence, focus and drive to succeed.
  • Exceptional interpersonal skills with an ability to stimulate innovation and creativity in others.

Additional qualifications include

  • An MD or MD/PhD with pharmaceutical or biotech experience. Board Certification in Neurology or Pediatrics is highly preferred.
  • An exceptional leader who can manage departmental and multidisciplinary project teams with experience in accomplishing results in a project-oriented matrixed environment.
  • A credible individual who can influence and work well with physicians, scientists, peers and managers.
  • A results-oriented, focused, proactive person who can analyze and diagnose issues, learn from mistakes, solve problems and provide alternative solutions.
  • An individual who demonstrates humility, good judgment, strong analytical skills, adjusting quickly to changes.
  • Excellent organizational and project management skills, and ability to think scientifically, clinically and strategically.
  • Outstanding presentation, written and oral skills are required. A clear communicator who can influence effectively both internally and externally.
  • Someone who can integrate into the environment, operates as part of an effective team, listens well and can make important decisions.
  • Must be a multi-tasker, roll-up-the-sleeves-and-contribute type.
  • Excellent people skills.
  • Innovative, strategic thinker – medically, operationally, scientifically.

  *Equal Opportunity Employer/Veterans/Individuals w/Disabilities*

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ROLE – Toxicologist/Pharmacologist (Associate Director/Director Level)

Ovid is seeking a senior toxicologist for a critical role in nonclinical safety evaluation supporting a number of ongoing clinical and preclinical development programs.  This individual will provide scientific leadership in nonclinical safety assessment, helping to build internal capabilities and support of all phases of the drug development process, from research through market application and commercialization.

Responsibilities

  • Provide nonclinical safety assessment expertise to assigned project teams
  • Nonclinical contract laboratory site identification and qualification
  • Nonclinical study budget development and study placement
  • Ensure regulatory compliance and maintain training/certifications
  • Potential to supervise others
  • Responsible for nonclinical GLP and non-GLP study design/protocol development, contract research laboratory (CRO) study director interactions/monitoring, study result interpretation, report review and finalization, and supporting preparation of integrated nonclinical summaries for regulatory submissions
  • Analyze, interpret and communicate nonclinical and clinical data
  • Design nonclinical safety testing program (including safety pharmacology, secondary pharmacology and toxicology testing) for assigned programs
  • Work closely with Clinical Development, Drug Safety and Clinical Pharmacology colleagues to develop integrated safety programs as well as clinical trial designs
  • Assess mechanism(s) of toxicity to determine clinical relevance and develop risk mitigation strategies
  • Participate in regulatory authority meetings
  • Work with internal and external collaborators and partners
  • Work closely with Project Managers and other team members to assure timely deliverables
  • Foster productive cross-functional collaborations with teams across the organization including Regulatory, Quality, Business Development, Research, Drug Safety, CMC, Commercial and Medical Science

Experience, Education, Specialized Knowledge and Skills

  • Strong commitment to make a meaningful difference in the lives of patients
  • Successful candidates will have a MS or Ph.D. in pharmacology or toxicology
    • Relevant biopharmaceutical industry experience required
      • MS—7 to 10 years
      • PhD—3-5 years
  • Strong scientific writing and presentation capabilities
  • Experience in drafting regulatory dossiers (eCTD)
  • Experience supporting clinical drug development teams
  • DABT preferred
  • Understanding of GLP’s and electronic submission requirements
  • Knowledge of pharmacokinetics
  • Experience with statistical principles, data analysis and graphical data representation
  • This role requires approximately 20-30% travel

*Equal Opportunity Employer/Veterans/Individuals w/Disabilities*

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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.

Responsibilities

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).

QUALIFICATIONS

  • 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*

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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).

Responsibilities

  • 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.

Requirements

  • 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*

 

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