Executive Director (Distinguished Scientist), Clinical Research, Atherosclerosis

Job description

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 meeting. She/he 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: Work closely with the 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 his/her areas of responsibility. The Executive Director is responsible for maintaining a strong scientific fund of knowledge by: Maintaining awareness of scientific developments within his/her 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 his/her 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 his or her competency and to maintain awareness of research activities in his/her 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. Qualifications: Education: M.D or M.D./Ph.D. Required: Minimum of 3 years of clinical medicine experience Minimum of 5 years of focused clinical development experience with demonstrated success in overseeing 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 with a strong publication record 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: Board Certified or Eligible in Cardiology (adult or pediatric), Endocrinology, or Nephrology or related discipline Minimum of 7 years of industry experience in drug development Successful product registration experience desirable Required Skills: Cardiovascular Diseases, Clinical Strategy, Clinical Trials, Cross-Functional Teamwork, Drug Development, Protocol Development, Regulatory Submissions, Scientific Leadership, Stakeholder Management Preferred Skills: Cardiology, Endocrinology, Nephrology 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. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement​ We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts The salary range for this role is $310,900.00 - $489,400.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits. You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider fo