Job Description

Our Clinical Development teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical standards.

The Distinguished Scientist (Executive Director) and Product Development Team (PDT) lead, Oncology Global Clinical Development, has primary responsibility for the planning and directing clinical research activities involving new or marketed drugs in the Oncology Clinical Research group and in the field of breast cancer. The Executive Director, PDT lead will manage the entire cycle of clinical development, including development strategy, study design, initiation, execution,monitoring, analysis, regulatory reporting, publication, and presentation at national and international meeting. They will provide internal scientific leadership for cross-functional areas supporting clinical trials and will interact externally with key opinion leaders.

Specifically, the Executive Director, PDT lead 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 clinical development strategies for investigational or marketed agents 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 agents.

• 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.

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

• support of business development assessments of external opportunities.

• Provide support for other therapeutic areas regarding clinical issues related to oncology compounds.

The Executive Director/PDT lead may:

• Manage Directors and/or Senior Directors responsible for Oncology Global Clinical Development projects.

• Supervise the activities of entire Clinical Teams in the execution of clinical studies.

• Will report and work collaboratively with the Associate Vice President to promote the development strategy of the company on the indication of interest.

• Work closely with a cross-functional Senior/ Executive Director group of experts in commercialization, regulatory affairs, statistics, medical affairs and manufacturing to manage clinical development projects; and assist the Associate Vice President in ensuring that appropriate Corporate personnel is informed of the progress of studies of our company and competitors' drugs and 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

• 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 their 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/ PDT lead 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.

Education:

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

Required Experience and Skills:

• Must have experience in industry in the field of breast cancer

• Minimum of 3 years of clinical medicine experience

• Minimum of 5 years of industry experience in drug development

• 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:

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. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

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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".

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. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.

Expected US salary range:

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. A summary of benefits is listed here.

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

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Requisition ID:R325825