Associate Medical Director, Clinical Sciences, Oncology
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 scientist, with experience running clinical trials, either in the pharmaceutical, biotech sector or academic setting. Works closely with supervisor and other members of the cross-functional team, contributes to the Clinical Development Plan CDP that meets international regulatory standards . Works with leaders across therapeutic area discipline and functions within Research, Preclinical Development, Early Clinical Development & Experimental Sciences, Biostatics and Data Management, Clinical Operations, Safety, Regulatory Affairs, and Marketing etc. to analyze development opportunities, plan, and execute clinical development studies of Regeneron's drug candidates . Job Duties . Responsible for oversight of cross-functional study team and provides medical guidance to the clinical study teams . Defines clinical trial-related goals and objectives . Responsible for the relevance and accuracy of medical science underpinning of clinical study concepts CSCs based on thorough scientific review and consultation with internal and external experts . Reviews, edits and finalizes clinical trial plans . Reviews and finalizes the medical and scientific portions of clinical trial protocols and amendments . Reviews and edits documents related to trials, such as monitoring plans, SAPs, amendments, IRB 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. Is the primary clinical contact for communications with regulatory agencies and IRBs/ethics boards . Conducts detailed literature reviews and analysis of development opportunities from mechanistic, pharmacological and clinical development perspectives . Organizes and conducts consultations with global opinion leaders . Supports & oversees clinical development planning, study design Phase 1 through Phase 3b , biomarker strategy, protocol creation, study startup, execution, data readout, and study closeout . Requirements . Education . MD required. Board Certification/Eligibility in the relevant therapeutic area preferred . Experience . 0-3 years prior industry experience or practice experience, preferably in a research/academic setting . Medical background in the relevant therapeutic area . 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 #LI-SC1, SKC, clinical research, oncology, immuno-oncology. 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.