Mary Callanan Md Email & Phone Number

United States

United States

Development of a new class of drugs made of messenger RNA (mRNA). This novel drug platform builds on the discovery that modified mRNA can direct the body’s cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells.Providing integrated and innovative clinical development strategy to support the creation and management of the Clinical Development Plan (CDP) for an asset in development• Integrating scientific rationale, regulatory requirements, product development plan andcommercial goals to optimize clinical study designs aligned with the Integrated DevelopmentPlan (IDP) and CDP• Generating the data and evidence required to determine a medicine’s potential efficacy, safetyprofile, key areas of product differentiation and value to patient in the shortest possible timeframe• Establishing expeditious clinical development timelines, incorporating key decision points andGo/No Go criteria for the CDP• Developing and maintaining relationships with program counterparts in Commercial, Research,Regulatory, Clinical Operations and Statistics• Contributing to and partnering on the development of strategic initiatives, specific BusinessDevelopment activities and various organizational initiatives in Clinical Development• Playing an active role in the technical and leadership development of Clinical Sciences staff viacoaching and mentoring and potential direct line management

Providing leadership and ongoing perspective to the company’s clinical development strategy. Working closely with the Senior Vice President, assume overall responsibility for managing Ovid’s2clinical development programs, and all aspects of clinical development, including indicationstrategy, the design and conduct of clinical trials, the selection of clinical trial sites, the selectionand training of physicians, the selection and management of CROs and the oversight, analysis andinterpretation of clinical data. Executing the existing OV101 and OV935 clinical programs as well as strategic input and executionof new clinical programs. Providing medical oversight to ensure the highest data quality from clinical studies. Providing medical review, assessment and interpretation of all clinical data reported in clinicalstudy reports to ensure that the data are presented with the appropriate medical interpretation. Responsible for Ovid meeting its 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 andparticipate in due diligence activities as required. Maintain understanding of competitor programs and clinical developments in relevant therapeuticareas and engage KOLs and consultants as required. In conjunction with the Chief Medical & Portfolio Officer, serve as a clinical face of the companyboth internally and externally, including the scientific community and key opinion leaders. Actively assist in seeking product and/or technology alliances with appropriate pharmaceuticalcompany partners to enhance/expedite the development of the company’s assets. Recruiting, supervising, and mentoring all direct reports. Help in attracting and retaining a top-notch clinical development team.

Infectious Disease / Pulmonology / Rare DiseaseProvides medical/scientific input and advice by working closely with Clinical Scientists and Clinical Operationspersonnel on clinical studies, before during and after conduct of studies, and identify/resolve issues related to studydesign that arise during study• Provide medical monitoring and direct interaction with investigational sites, investigators, and when appropriate KeyOpinion Leaders• Provide medical expertise where needed (which may include assisting colleagues in Pharmacovigilance).• Collaborate with team and CROs to prepare and finalize clinical study protocols, associated amendments and SpecialProtocol Assessment (SPA) Agreements in compliance with Clinical Development Plans and regulatory requirements.• Provide program level medical oversight of information included in regulatory documents including clinical sections ofIND submissions, IND Annual Updates / DSUR, Investigator Brochures and IMPD's Draft, briefing books, clinical sectionsfor the NDA/CTD submissions, and responses to questions from regulatory authority or EC/IRBs.• Support preparation of abstracts, manuscripts, presentations, and materials for Advisory Meetings.• Present protocols and supporting presentations at Investigator Meetings and as needed for other meetings or trainingpurposes.• Provide medical feedback for activities related to review of data for interim analysis or blinded data reviews.• Provide medical/scientific review of statistical analysis. • Collaborate with team in the development and implementation of Data Management activities including developmentof eCRFs, edit checks, coding, report development and database lock processes.• develops and maintain relationships with outside experts. May serve as a liaison by representing the company in outside groups.strategic development of early and late stage clinical programs.process creation and SOP writing and updating as needed.due diligence work

New York

Director Medical Affairs Bile Acid Disorders/Gastroenterology/Hepatology/Genetic Metabolic DisordersTravere Therapeutics (formerly Retrophin) is a biopharmaceutical company focused on the discovery and development of drugs for the treatment of catastrophic diseases that are debilitating and often life-threatening, and for which there are currently limited patient options.Launch of CHOLBAM

Teva Neuroscience

Host for NationalSatellite XM radio channel ReachMD, the channel for medical professionals. Developed and produced thought-provoking medical content for health professionals

Nyc

Neurology / Cardiology / Rare Disease

New York

Bachelor Of Medicine (Md), Medicine

Diploma In Film & Television