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.
Qualified physician or scientist with significant pharmaceutical/biotechnology sector and/or exceptional academic clinical trials experience. With oversight from supervisor, works with other members of the cross-functional team to author early clinical development protocols and facilitate/lead execution of study activities and data summarization.
• Facilitates/leads the cross-functional study team on the following activities, including but not limited to:
• 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.
o 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.
• Responsible for oversight of cross-functional study team and provides medical guidance to the clinical study teams.
• Accountable, with input from Clinical Trial Management and Biostatistics and Data Management for timely clinical trial execution and quality of deliverables:
o Leads and supervises the Clinical Team to produce high quality program deliverables on schedule
o Identifies program, trial or data risks, creates and implements mitigation strategies
o Maintains and develops relationship with key study investigators
o Organizes clinical expert consultations, steering committees and data safety monitoring boards as required
o Reports to supervisor and management on clinical trial findings and milestones
o Responsible for the medical content of clinical study reports
o Reviews all medical/scientific publications related to clinical trial
• Analyzes the benefits and risk aspects of an assigned therapeutic candidate:
o Responsible for the analysis of clinical data, including safety monitoring
o 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 is a key contributor in meetings with agencies.
• Demonstrated capability to supervise and mentor less experienced personnel.
• Identifies and recommends resource allocation for CDP execution
o Identifies changes to established practices/policies if appropriate
o Identifies potential opportunities for optimal resource allocation
• Conducts detailed literature reviews and analysis of development opportunities from mechanistic, pharmacological and clinical development perspectives.
• With oversight from the ECD&ES TFA Primary Responsible, takes lead on major/significant 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.
• 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 extensive relevant industry experience.
• 4 – 8 years of clinical research pharmaceutical industry experience, or significant relevant experience in academic clinical trials.
• Has authored industry documents and/or has published in medical/scientific peer-reviewed journals. Interactions with Regulatory agencies or Common Technical Document (CTD or “dossier”) submission in any ICH region are an advantage.
• 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.
• Prior experience with mentoring and leading cross functional teams.
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.