Senior Principal Scientist, Clinical Research, Prostate Cancer

Job Description

The Senior Director (Senior Principal Scientist) has primary responsibility for the planning and directing clinical research activities involving new or marketed Oncology medicines. Our company's Oncology medicines span all phases of clinical development (pre-clinical to post-licensure). The Senior Director will manage the entire cycle of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.

Specifically, the Senior Director may be responsible for:

• Evaluating pre-clinical and translational work for the purpose of generating early clinical development plan and Investigational New Drug applications.

• Developing of clinical development strategies for investigational or marketed Oncology drugs

• 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 Oncology drugs.

• 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 publication; and

• Participation in internal and joint internal/external research project teams relevant to the development of new compounds, and the further study of marketed compounds. In executing these duties, the

The Senior 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 Senior Director in ensuring that appropriate corporate personnel are informed of the progress of studies of our company's and competitors' drugs and internal and external expert opinion on scientific questions relevant to his/her areas of responsibility.

• The Senior 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

• Identification of 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 Senior Director may:

• Author detailed development documents, presentations, budgets, and position papers for internal and external audiences

• Facilitating 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

Minimum education required:

M.D or M.D./Ph.D.

Required experience and skills:

• Must have experience in industry or senior faculty in academia

• Minimum of 3 years of clinical medicine experience

• Minimum of 1 year of industry experience in drug development or biomedical research experience in academia

• Demonstrated record of scientific scholarship and achievement

• A proven track record in clinical medicine and background in biomedical research is essential

• Strong interpersonal skills, as well as the ability to function in a team environment are essential.

Preferred experience and skills:

• Board Certified or Eligible in Oncology (and/or Hematology)

• Prior specific experience in clinical research and prior publication

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

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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:

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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.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as remote.

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 for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Required Skills:

Bladder Cancer, Cancer Research, Clinical Development, Clinical Judgment, Clinical Research Management, Clinical Testing, Clinical Trial Development, Clinical Trials Monitoring, Data Analysis, Drug Development, Intellectual Curiosity, Interdisciplinary Problem Solving, Oncology Research, Project Reviews, Prostate Cancer, Regulatory Affairs Compliance, Regulatory Compliance, Regulatory Reporting, Scientific Publications, Strategic Planning, University Education

Preferred Skills:

Job Posting End Date:

06/13/2025

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