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Senior Principal Scientist (Senior Director), Clinical Research, ADC

$282.2k

Merck & Co. Inc

Job Overview The Senior Clinical Director (Senior Principal Scientist) has primary responsibility for planning and directing clinical research activities involving new medicines in the Oncology Asset therapeutic area. The Senior Clinical Director may manage the entire cycle of clinical development for their assigned studies including study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication. Role Responsibilities 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 drugs. Planning clinical trials (designing, collaborating on operational plans, etc.) based on the clinical development strategy. Medical oversight and overall conduct of ongoing or new clinical trials for investigational drugs, including dose optimization studies. Analyzing and summarizing clinical findings to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publication. Participating in internal and joint internal/external research project teams relevant to the development of new compounds. Working with tumor teams (PDTs) for the transition of new investigational drugs to registrational studies. Supporting business development assessments of external opportunities. Actively engaging with other functional areas in support of study execution. Working closely with a cross‑functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects. Assisting the Executive Director and/or Associate Vice President in ensuring that appropriate personnel are informed of the progress of studies of our company and competitors’ drugs. Providing expert opinion, internally and externally, on scientific questions within their responsibility. Maintaining a strong scientific fund of knowledge, including awareness of scientific developments, identifying strong investigators, establishing communications with prominent clinical investigators, and attending relevant scientific meetings. Authoring detailed development documents, presentations, budgets, and position papers for internal and external audiences. Facilitating collaborations with external researchers around the world. Traveling on company business about twenty percent of the time to manage future or ongoing clinical research projects. Education M.D. or M.D./Ph.D. Required Experience and Skills Experience in industry or as senior faculty in academia. Minimum of 3 years clinical medicine experience. Minimum of 3 years industry experience in drug development or biomedical research experience in academia. Demonstrated success in overseeing clinical studies and protocols. Demonstrated record of scientific scholarship and achievement. Proven track record in clinical medicine and background in biomedical research. Strong interpersonal skills and the ability to function in a team environment. Provide expert opinion, internally and externally, on relevant scientific questions within their responsibility. Preferred Experience and Skills Board Certified or Eligible in Oncology or related discipline. Prior specific experience in clinical research and prior publication. Required Skills Antibody Drug Conjugates, Clinical Development, Clinical Documentation, Clinical Medicine, Clinical Reporting, Clinical Trial Development, Clinical Trials, Drug Development, Ethical Standards, Oncology, Pharmaceutical Development, Regulatory Compliance, Regulatory Reporting, Strategic Planning. Equal Employment Opportunity Statement 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 the EEOC website. Salary and Benefits Salary range for this role: $282,200.00 – $444,200.00. Eligible for annual bonus and long‑term incentive, if applicable. 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. #J-18808-Ljbffr

Vacancy posted 7 hours ago
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