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.
• 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

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.

• 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.
• 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.
• 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.
• Support preparation of abstracts, manuscripts, presentations, and materials for Advisory Meetings.

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.

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