Senior Staff Scientist, Clinical Pharmacology
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 The Senior Staff Scientist, Clinical Pharmacology will provide support to a Director within Clinical Pharmacology, providing strategic and scientific expertize, as well as representing Clinical Pharmacology at relevant meetings. This position will provide CP subject matter support to new and on-going clinical programs. Responsibilities . Together with the Director, develop and maintain comprehensive clinical pharmacology strategic development plans for assigned development programs . Together with the Director, provide clinical pharmacology subject matter expertise to the Clinical Study Team/ Development Team . Participate in the drafting and finalization of clinical study protocols and study analysis plans SAP . Supervise and/or conduct pharmacokinetic / pharmacodynamic analyses . Draft, finalize, and/or review clinical pharmacology study reports and publications. Work with the Medical Writing Team to incorporate PK/PD sections into clinical study reports . Together with the Director, work closely with Regulatory to provide clinical pharmacology support of regulatory documents, communications and presentations as needed IND, health authority inquires, preparation/participation in meetings with health authorities, preparation of BLA summary sections, addressing review inquiries, health authority sponsored Advisory Committee Meetings . Work closely with Quantitative Pharmacology colleagues to develop and deliver agreed quantitative strategies to support assigned development plans . Assist the Pre-clinical PK/PD Team as needed . Requirements Education . PhD, Biology, Pharmacology, Engineering, Pharmacy Pharm. D , Medicine MD . Experience . 5 plus years 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.