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. We are in a growing life science ecosystem, which equips us with the resources and capabilities to better serve our patient communities. Ovid channels the city’s 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 diseases 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 privately-held, New York-based, clinical-stage biopharmaceutical company committed to transforming the lives of patients with rare and orphan diseases 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. The company completed a $75 million Series B fundraising round in August 2015.
The patient advocacy director supports enhances our engagement with the patient community and is key to our mission at Ovid Therapeutics to build strong relationships with the patient community. The director will report to the chief medical and portfolio management officer and will work cross-functionally with development, regulatory and commercial teams to ensure alignment of a patient-focused culture across Ovid’s strategic objectives. He/She will identify solutions that educate and empower patient organizations to improve patient’s disease awareness, quality of life, and access to therapies. The director works with patients, physicians, their families and patient advocacy groups to plan and implement short and long term programs to meet the diverse needs of the Angelman syndrome and Fragile X syndrome patient communities.
- Weave the patient voice into global research and development efforts including clinical development, medical affairs, marketing, market access, government relations, etc.
- Keep abreast with industry and health care legislation. Communicate updates to the external patient communities and key internal Stakeholders.
- Implementing the short and long-term strategies to integrate and advance the various patient resources and support services offered to the Rare disease patient community.
- Providing strategic insight on the pulse of the patient populations and ensuring strong collaborations with patient advocacy groups.
- Building relationships and providing guidance to existing and/or evolving patient associations.
- Identification and coordination of patient and/or caregiver presentations to internal Ovid meetings.
- Articulate the themes of the overall patient community to your internal Ovid colleagues at any given point and time.
- Successfully work with internal functions and external patient organizations to help them grow and develop into high functioning, sustainable organizations.
- Staying current with relevant information and resources regarding industry and health care legislation. Providing updates regularly to the disease communities.
- Demonstrated leadership abilities with large and small groups.
- Commitment to make a meaningful difference in the lives of patients.
- Bachelor’s + Masters degree in science, social science or related field.
- 7+ years experience in healthcare or social services, non-profit, or corporate setting (marketing, public relations, communications, patient, consumer or professional association, psychology or social science or related role).
- Understanding of the pharma/biotech industry, regulatory process & compliance guidelines.
- Ability to work collaboratively and cross functionally across multiple stakeholder organizations.
- Committed, empathetic individual with the ability to relate to diverse groups and build substantive relationships with stakeholders, specifically those understanding the impact of living with a rare disease.
- Excellent interpersonal, oral and written communication skills including strong presentation capability and the ability to effectively deliver information and influence stakeholders.
- Ability to travel domestically 15-20%.
- Preferred: Master’s degree in psychology, counseling or social work preferred.
We seek an experienced pharmacologist/toxicologist to facilitate the advancement of the Ovid drug development pipeline. This individual will provide scientific leadership and play a pivotal role to build an internal capability and provide nonclinical expertise in support of all phases of the drug development process from research through market application and commercialization.
- Generate the preclinical plan in partnership with respective clinical development team members; design pharmacology, pharmacokinetics and toxicology studies to support drug candidate optimization and selection, and integrate data required to understand performance of products in the clinical setting.
- Foster productive cross-functional collaborations both within internal and external cross-functional sub-teams and collaborators throughout the drug development lifecycle in an effort provide a balanced assessment as to the risk/benefit profile associated with a drug candidate’s advancement.
- Ensure budget, timelines and performance requirements are met; build a scalable model.
- Work closely with collaborators on animal models of disease including an in-depth understanding of disease etiology.
- Ensure regulatory submission and compliance standards are met; draft, edit and finalize nonclinical study and technical report and contribute to IND and future BLA submissions as well as required data to ensure regulatory compliance.
- Effectively communicate nonclinical findings and their relevance to senior management, project teams, collaborators and regulatory agencies.
- Advise cross-functional team members on technical and operational hurdles.
- Commitment to make a meaningful difference in the lives of patients.
- Ph.D. or equivalent advanced scientific degree and background.
- Nonclinical pharmacology/toxicology background with 7+ years of experience in the pharmaceutical, and/or biotechnology field.
- Experience building non-clinical program strategy and design including the design, conduct, and interpretation of GLP or non-GLP nonclinical pharmacology and toxicology studies.
- Experience in partnering with regulatory affairs on submissions (IND/CTDs, NDA/BLA, etc.) and communicating/interacting with health authorities.
- Expertise in in vivo pharmacology or experience with animal models of disease.
- Ability to interpret and synthesize diverse multidisciplinary data sets.
- Experience and ability to work collaboratively in cross-functional teams.
The Global Regulatory Liaison will serve as the Regulatory member of our core development team and the main liaison with US and RoW health authorities.
- Leads development of global regulatory strategies to ensure high likelihood of success of submissions/approvals.
- Liaises with global regulatory authorities to manage day-to-day communications and operations.
- Contributes to the clinical development plans, regulatory strategic plans, and provides advice on US and EU regulatory clinical trial and marketing authorization requirements to the project team.
- Manages and implements strategies to identify, monitor, and resolve regulatory issues
- Organizes resources and processes across multiple teams / functions to develop and deliver complete regulatory submissions within agreed timeframes.
- Prepares and writes regulatory documents for submissions.
- Sets priorities, key deadlines, and project milestones for regulatory function for assigned program.
- Manages individual contributors and coaches teams for agency interactions, leads meetings, organizes debriefs, and communicates summary to management.
- Prepares plan and internal SOP’s to manage regulatory compliance and reporting requirements.
- Sc or M.Sc. in relevant field and at least 5 years of overall experience in the pharmaceutical industry.
- In-depth knowledge of FDA regulatory requirements and IND applications.
- Experience with multiple Health Authorities (EMA, PMDA) interactions and Scientific Advice proceedings is a plus.
- Ability to assume accountability for a project goal/objective.
- Experience working in cross-functional teams and with CRO’s, leading team discussions to resolve and reach agreement on project issues.
- Excellent written and oral communication skills.
- Proven ability to motivate others and build effective teams.
- Proficient in preparing eCTD submissions.
- Knowledge in CNS disease area and Orphan Diseases is preferred.
- Travel: Approximately 10% domestic and international travel for meetings with health authorities and conferences.
The medical director is responsible for creating Ovid’s drug safety & pharmacovigilance (PV) function as well as providing strategic and operational PV leadership throughout the drug portfolio lifecycle. The director is responsible for safety surveillance, risk management and risk communication for drug development candidates and future marketed products, as well as medical assessment of individual adverse event reports, generation, and review of aggregate reports and safety documents. She/He will ensure that the safety surveillance and benefit risk management activities are consistent with global regulatory requirements as well as Ovid’s operating processes, procedures, regulatory and legislative requirements. The director will manage drug safety support for internal cross-functional and external resources. This role helps drive the company’s research and development efforts with our mission to create high value therapeutics that address unmet medical needs.
- Work with the Development Leaders to develop the strategy and implementation of safety and benefit-risk management for Ovid portfolio.
- Serve as the medical safety expert for all products at all stages of clinical development (Phase I, II, III and post-approval).
- Responsible for appropriate review of all safety data from various sources (e.g. pre-clinical, clinical trial data, post-marketing, literature) throughout the development process.
- Responsible for the conducting signal detection activities, monitoring, evaluation, interpretation and appropriate management and communication of safety information.
- Share Drug Safety and medical expertise with counterparts in other functional and geographic areas such as Clinical Development, Regulatory Affairs,, Medical Sciences, Marketing and Legal.
- Provides ongoing QPPV advice to senior management on the changing risk-benefit profile of company drug products in clinical trials, based on analyses/evaluation of potential safety signals.
- Manage compliance with SOPs and global regulations for the reporting of adverse events to regulatory agencies, IRB/Ethics committees and Investigators.
- Directs the development and preparation of reports for company management and regulatory agencies. Directs the development, preparation and compliance of periodic and annual safety reports (e.g. US IND annual progress reports, EU annual safety reports, periodic line listings, NDA safety updates, etc.), investigator communications, product labeling/package inserts and other reports as necessary.
- Commitment to make a meaningful difference in the lives of patients.
- MD degree required with 5+ years of experience in pharmaceutical industry within Drug Safety/ Pharmacovigilance with both investigational and marketed products.
- Expertise in clinical safety assessments, safety signal detection and risk management, including interactions with regulatory authorities; significant track record working with safety databases.
- In-depth knowledge and thorough understanding of FDA, EU, and global regulations, ICH guidelines, and GCPs that govern drug safety and pharmacovigilance.
- Ability to research and understand the safety profiles of competitor products within rare and orphan diseases of the brain to help develop effective competitive strategies.
- Strong skills in presenting drug safety topics for regulatory authorities, or at conventions, meetings, etc.
- Effective and collaborative partner working cross-functionally and with external collaborators.
- Excellent oral and written communication skills.
Ovid’s pipeline is expanding rapidly, necessitating growth of the research team. This incoming scientist will work with contract research organizations, and in some instances academic collaborators, to test specific experimental hypotheses relating to in-house assets. Extensive hands-on experience carrying out neuroscience research is essential. This background will enable:
- Rapid familiarization with disease related literature and appropriate model systems
- Development of appropriate detailed research protocols (in collaboration with internal research team and external parties)
- Day to day oversight of external activities and progress
- Interpretation and communication of results to the internal team
Extensive hands on experience carrying out neuroscience research, either in an academic or industry setting, is a must. She or he should have an MSc or preferably a Ph.D. in biochemistry, molecular biology, neuroscience or a related field. Expertise in electrophysiological research techniques and a background in pediatric epilepsies is highly desirable.
The successful candidate will be internally motivated, comfortable working independently, and strive to proactively mitigate risks. The desire to be in a rapidly changing start-up environment is also necessary.
Kristen Alexander | Talent Acquisition & Engagement | Ovid Therapeutics email@example.comAPPLY FOR THIS POSITION