Assoc. Medical Dir/ Director - Clinical Sciences Asthma/Immunology
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases . Summary . Qualified physician with experience in the pharmaceutical/biotechnology sector,or academic clinical setting who working with other members of the cross-functional study team would contribute to, and advance the Clinical Development Plan CDP of assigned assets. Primary responsibility will be to contribute in the. development study protocols and oversee activities related to execution and medicalmonitoring of clinical trials . Responsibilities . Essential Functions required for the job . Contributes to/leads the cross-functional study team on the following activities,including but not limited to . Support &oversees ClinicalScience activities related to clinical development planning,study design. Phase 2 through Phase 3b ,study startup,execution, data readout,and study closeout . Collaborates/designs, reviews and finalizes clinical study concepts CSCs and clinical study protocols CSPs and amendments as per clinical strategy . Responsible for the relevance and accuracy of medical science underpinning of clinical study based on thorough scientific review and consultation with internal and external experts . Conduct detailed literature reviews and analysis of development opportunities from mechanistic,pharmacological and clinical development perspectives. Clinicalmonitoring of one or more studies . Leads clinical study team with input from Clinical TrialManagement,data management,and study statistician for timely clinical trial execution and high quality program deliverable . Addresses relevant clinical queries from study sites . and authors responses to study related HA. and IRB questions . Reviews and edits documents related to trials,such as monitoring plans,SAPs,amendments, IRB/IEC submissions and regulatory submissions . Responsible for activities and procedures that ensure patient safety . Identify and builds relationships with investigators,CROs and external experts. I Interprets data from an overall scientific standpoint as well as within the context ofthe medical significance to individualpatients . Supports generation and coordination of clinical documents and deliverables in-support of regulatory filings . Responsible for the medical contentof clinical study reports . Reports to supervisor and management on clinical trial findings and milestones . Requirements . Education . MD required. Board Certification/Eligibility in the pulmonary/allergy/immunology therapeutic area preferred . Experience . At least 1- 2 years of clinical research experience in pharmaceutical/biotechnology sector,or significant relevant experience in academic clinical trials . Has a deep understanding of the fundamentals of protocol development and follow up,including but not limited to . Study monitoring, data collection and analysis,database cleaning and database lock . Effective communications verbal& written and presentation skills. are essential . Must be able to work productively in a fast-paced collaborative environment . Demonstrated critical thinking skills and sound decision-making . Ability to work collaboratively in a fast paced,team-based matrix environment and to function independently as appropriate . Global clinical research experience and experience interacting. with regulatory authorities is a plus . SKC, #LI-SC1, medical director, associate medical director, clinical research physician, allergy, immunology, rheumatology, endocrinology, metabolic disease . This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business . To all agencies . Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid . Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.