Senior Medical Director / Physician Scientist - Early Clinical Development
Compensation: $186,460.00 - $186,460.00 /year *
Employment Type: Full-Time
Industry: Scientific Research
Position Summary Known for its scientific and operational excellence, Regeneron is a leading science-basedbiopharmaceutical 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 Director, ECD&ES, will lead/support conduct of clinical studies and will play a key leadership role in clinical development programs, including being accountable for deliverables of the assigned program(s), resourcing, budget and timelines. May serve as scientific and medical lead for clinical team(s) working closely with operational leads. May assume leadership responsibility for a large section/indication of a development plan, or an entire asset development plan. May provide strategic scientific and clinical foresight, insight, and oversight for therapeutic candidates about to enter clinical experiments, and s/he will collaborate with the corporate partner clinical teams, providing medical and scientific support for the programs and communication with the medical community, establishing Regeneron as a key and competitive player. S/he will also work effectively with regulatory agencies both in the U.S. and internationally. Job Duties: o Contributes to the development of the early clinical strategy in terms of indication selection, study rationale, scientific/clinical endpoints, etc. o Facilitates/leads the cross-functional study team on the following activities, including but not limited to: o Designs POC-enabling human studies, First-In-Human (FIH) studies, POC (clinical and/or pharmacologic) studies as per clinical strategy. o Responsible for the relevance and accuracy of medical science underpinning of clinical study basedon 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 o Reviews and finalizes the medical and scientific portions of clinical study concepts (CSCs) and clinical study protocols (CSPs) and amendments. o Reviews and edits documents related to trials, such as monitoring plans, SAPs, amendments, IRB/IEC submissions and regulatory submissions. o Responsible for oversight of cross-functional study team and provides medical guidance to the clinical study teams. o 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 o 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 o Ensures Clinical Team compliance with FDA, EMEA, ICH and GCP guidelines as well as applicable SOPs regarding clinical safety. o Authors/contributes to clinical sections of communications/documentation for regulatory agencies and is a key contributor in meetings with agencies. o Demonstrated capability to supervise and mentor less experienced personnel. o 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 o Conducts detailed literature reviews and analysis of development opportunities from mechanistic, pharmacological and clinical development perspectives. o Working with 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. Requirements: Education o M.D. degree. Board Certification/Eligibility in a relevant therapeutic area preferred, along with relevant industry experience, (MD/Ph.D. preferred) or o Bachelor's degree in biomedical subject, master's degree preferred, along with extensive relevant industry experience. Experience o 8+ years of clinical research pharmaceutical industry experience, or significant relevant experience in academic clinical trials. o Experience with FDA Advisory Panels with knowledge of the international regulatory and clinical development process is desirable. o Successful history preparing and filing INDs and NDAs/BLAs resulting in drug approvals both in the US and preferably ex-US is desirable. o Significant clinical trial experience in relevant therapeutic area assigned will be a positive asset; other associated relevant therapeutic area experiences may be acceptable and evaluated on case by case basis. o Breadth and ability to be adaptable and work with appropriate foresight and forward thinking. o Excellent communications skills (verbal and written); capable of articulating the Company's clinical strategies and results to worldwide audiences. o Ability and strong desire/drive to "make things happen." A results-oriented work ethic, a positive, can-do attitude, and a proven ability to build an effective organization by attracting and retaining highcaliber personnel. o Intellectually curious with a passion for developing innovative pharmaceutical drugs. Creative, "thinks outside the box," willing to take responsible risks. o Effective leadership, people management, a team builder style and a global orientation are essential. o Must have highest personal values and ethical standards. 14218BRSalary Range: NAMinimum Qualification8 - 10 years
Associated topics: drug, food, immuno oncology, industrial hygienist, kinesiology, medical, nutrition, pharmacy, therapeutic, therapy
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.
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