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.
* 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.
* 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*
Associated topics: design, engineering, manufacture, product, product manager, production, program manager, quality