Job Description The Executive Director (Distinguished Scientist) has primary responsibility for the planning and directing of clinical research activities involving new or marketed medicines in the Atherosclerosis section of the Atherosclerosis & Metabolism therapeutic area. The Executive Director will manage and oversee the entire cycle of late stage clinical development from Phase 2 to Phase V, including development of program strategy and design, protocol authoring, initiation, execution, monitoring, analysis, regulatory reporting, publication, and presentation at national and international meetings. They will lead cross-functional product development teams that oversee program strategy and execution, will provide internal scientific leadership for cross-functional areas supporting clinical trials, and will interact externally with key opinion leaders. Specifically, the Executive Director may be responsible for: Evaluating pre-clinical and translational work for the purpose of generating early clinical development plans and Investigational New Drug applications Developing clinical development strategies for investigational or marketed medicines that incorporate the latest scientific developments, regulatory requirements, the competitive landscape, and commercial considerations Planning clinical trials (design, operational plans, settings) based on these clinical development strategies Monitoring and managing the conduct of ongoing or new clinical trials for investigational or marketed medicines Leading cross-functional product development teams that oversee overall strategy and execution for investigational or marketed medicines Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publications Participating in internal and joint internal/external research project teams relevant to the development of new compounds, and the further study of marketed compounds Supporting business development assessments of external opportunities. Managing other Directors and/or Senior Directors responsible for Atherosclerosis clinical development projects The Executive Director may supervise the activities of Clinical Scientists in the execution of clinical studies. Work closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects, and assist the Associate Vice President and/or Vice President in ensuring that appropriate Corporate personnel are informed of the progress of studies of our company and competitors' drugs, and of internal and external expert opinion on scientific questions relevant to their areas of responsibility. The Executive Director is responsible for maintaining a strong scientific fund of knowledge by: Maintaining awareness of scientific developments within their area of expertise, in terms of new scientific findings, research methodologies Identifying scientifically and operationally strong investigators who can assist in the development of our company's investigational and marketed drugs Establishing communications with prominent clinical investigators in their particular field of interest, particularly those who will be willing and able to assist in the evaluation of our company's drugs Attending appropriate scientific meetings to maintain their competency and to maintain awareness of research activities in their area of responsibility. To accomplish these goals, the Executive Director may: Author and/or oversee detailed development documents, presentations, budgets, and position papers for internal and external audiences Facilitate collaborations with external researchers around the world Travel on company business about twenty (20) percent of the time to manage future or ongoing clinical research projects. Education: M.D or M.D./Ph.D. Required Experience and Skills: Minimum of 3 years of clinical medicine experience Minimum of 5 years of industry experience in drug development with demonstrated success in overseeing multiple studies and protocols through completion, and experience in authoring regulatory documents and leading discussions with regulatory agencies Demonstrated record of scientific scholarship and achievement Proven track record in clinical medicine and background in biomedical research Outstanding interpersonal and collaborative skills, as well as the ability to function in a matrix environment Outstanding verbal and written communication and presentation skills Preferred Experience and Skills: Board Certified or Eligible in Cardiology (adult or pediatric), Endocrinology, or Nephrology or related discipline Prior specific experience in clinical research and prior publication record Successful product registration experience desirable Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Expected US salary range: $304,800.00 - $479,800.00 Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Hybrid Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 04/11/2025 #J-18808-Ljbffr MSD
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