Medical Director, Clinical Research- Cardiovascular/Metabolism
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 with pharmaceutical industry experience in Cardiovascular/Metabolism Therapeutics Development. Working closely with the Therapeutic Area Head VP, Clinical Sciences , contributes to the strategic planning of the Clinical Development Plan CDP that meets international regulatory standards. Serves as Scientific and Medical Lead for Clinical Team that oversees the execution of the CDP according to GCP . Works in close collaboration with Clinical Project Managers and Clinical Trial Managers at the study level, and with Therapeutic Area Program Managers at the CDP level. Responsible for the design of clinical study concepts leading to clinical trial protocols. Responsible for the medical/scientific supervision of individual clinical trials. Accountable for all deliverables of clinical trials under her/his direct responsibility. Contributes to scientific advisory boards, study steering committees and safety monitoring boards . Responsibilities . Defines clinical trial-related Clinical Development Program CDP goals and objectives . Responsible for the relevance and accuracy of medical science underpinning of clinical study concepts CSC based on thorough scientific review and consultation with internal and external experts • Reviews and finalizes clinical study concepts for presentation to TA Head and Sr. Management . Reviews and finalizes the medical and scientific portions of clinical trial protocols derived from CSCs . Accountable, along with CTM, for timely clinical trial execution and quality of deliverables • Leads and supervises the work of Clinical Team to produce high quality program. deliverables on schedule • Identifies program risks, creates and implements mitigation strategies • Maintains and develops relationship with key program investigators • Organizes clinical advisory boards, steering committees and data safety . monitoring boards as required • Reports to TA Head and senior management on clinical trial milestones • Responsible for the medical content of clinical study reports • Reviews all medical/scientific publications related to clinical trials . Establishes the benefit . risk ratio of a therapeutic candidate in CDP-defined indications • Responsible for the analysis of clinical data, including safety monitoring • Responsible for all activities and procedures that ensure patient safety . Ensures Clinical Team compliance with FDA, EMEA, ICH and GCP guidelines • Is the primary clinical contact for communications with regulatory agencies and. IRBs/ethics boards . Identifies and recommends resource allocation for CDP execution • Identifies changes to established practices/policies if appropriate • Establishes and monitors CDP budget . Requirements. 1. Recognized expertise in developing Cardiovascular/Metabolism therapeutics. a. Working understanding of statistical principles . 2. Has working knowledge of GCP, ICH , US FDA and EMEA regulations . 3. Successfully conducted exploratory clinical and/or confirmatory development. a. Strong analytical and problem solving skills . b. Demonstrated mastery of complex tasks . 4. Rigorous work ethics with focus on details and high quality results . 5. Works effectively under pressure . 6. Ability to work in matrix environment "dotted-line" authority . a. Able to lead by influence. b. Able to develop and communicate a vision. c. Able to foster commitment in team members and peers. d. Able to build successful collaborations with internal and external partners . 7. Able to manage clinical trial resources. a. clinical trial budgets. b. Able to identify human resource needs. c. Able to make appropriate assignments to meet challenges . 8. Superior written, and oral communication skills . a. Scientific presentation environments. b. Corporate management environments. c. Clinical team environments . 9. Able to develop original ideas . 10. Available to travel up to 20 of work time . Education and Experience . MD or equivalent with 3 to 7 years pharmaceutical industry experience. Experience in Cardiovascular/Metabolism Drug Development is required. Interactions with Regulatory agencies or Common technical document CTD or "dossier" submission in any ICH region is an advantage . SKC, #LI-SC1, Medical Director, clinical research physician, cardiovascular, metabolism, lipid, lipidology, . 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 .