AD-Director, Early Clinical Development and Experimental Sciences
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, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain, and infectious diseases . Summary . Qualified physician or scientist with experience in the pharmaceutical/biotechnoloigy sector, or academic clinical setting. Works with supervisor and other members of the cross-functional study team to author/contribute to early clinical development protocols and facilitate execution of study activities and data summarization . Responsibilities . Contributes to/leads the cross-functional study team on the following activities, including but not limited to . Collaborates on/designs POC-enabling human studies, First-In-Human FIH studies, POC clinical and/or pharmacologic studies 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. Reviews, edits and finalizes clinical trial plans. Organizes and conducts consultations with global opinion leaders . Reviews and finalizes the medical and scientific portions of clinical study concepts CSCs and clinical study protocols CSPs and amendments . Reviews and edits documents related to trials, such as monitoring plans, SAPs, amendments, IRB/IEC submissions and regulatory submissions . Accountable, with input from Clinical Trial Management and Biostatistics and Data Management for timely clinical trial execution and quality of deliverables . Leads and supervises the Clinical Team to produce high quality program deliverables on schedule. Identifies program, trial or data risks, creates and implements mitigation strategies. Maintains and develops relationship with key study investigators. Organizes clinical expert consultations, steering committees and data safety monitoring boards as required. Reports to supervisor and management on clinical trial findings and milestones. Responsible for the medical content of clinical study reports. Reviews all medical/scientific publications related to clinical trial . Analyzes the benefits and risk aspects of an assigned therapeutic candidate . Responsible for the analysis of clinical data, including safety monitoring. Responsible for activities and procedures that ensure patient safety . Ensures Clinical Team compliance with FDA, EMEA, ICH and GCP guidelines as well as applicable SOPs regarding clinical safety . Authors/contributes to clinical sections of communications/documentation for regulatory agencies and may participate in meetings as needed . Conducts detailed literature reviews and analysis of development opportunities from mechanistic, pharmacological and clinical development perspectives . Working with the ECD&ES Disease Area Lead, takes lead on various collaborations with TFA Research and Regeneron Genetic Center RGC colleagues to understand current and emerging targets/molecule program, provide clinical input on potential disease areas/indications, and design clinical experiments that corroborate or inform the biology for decision-making purposes . Requirements . Education . M. D. degree. Board Certification/eligibility in a relevant therapeutic area preferred, along with relevant industry experience, or . Ph. D. degree. Post-doctoral experience preferred, or . Bachelor's degree in biomedical subject, master's degree preferred, along with relevant industry experience . Experience . 2-4 years prior industry experience or practice experience, preferably in a research/academic setting . Experience in analysis of clinical and basic research information from a wide range of topics . 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 . 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.