Distinguished Scientist, Clinical Research, Thoracic Malignancies

Merck & Co.; Upper Gwynedd Township (Montgomery County); Hybrid; USD 311,000 - 489,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Hybrid work arrangement

Competitive benefits

Job summary

Merck & Co. in Rahway, NJ, seeks an Executive Director, PDT Lead to guide the full cycle of clinical development for thoracic oncology drugs, from strategy through regulatory submission.

You will lead cross-functional teams across development, regulatory, statistics and medical affairs to drive high-quality trials and impactful publications. The role requires an MD or MD/PhD, 5+ years in industry drug development, 3+ years of clinical medicine in oncology, and a strong track record in biomedical

Qualifications

• Must have industry experience in Thoracic Oncology.
• 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 and ability to function in a team environment.

Responsibilities

• Manage Directors/Senior Directors responsible for Oncology Global Clinical Development projects.
• Supervise activities of Clinical Teams in execution of clinical studies.
• Collaborate with Section Head to promote development strategy and inform stakeholders.
• Work with cross-functional teams in commercialization, regulatory affairs, statistics, medical affairs and manufacturing.
• Ensure progress of studies is communicated to relevant personnel and external experts.

Skills

Clinical Development

Clinical Judgment

Clinical Medicine

Clinical Research

Clinical Trial Planning

Clinical Trials

Cross-Cultural Awareness

Cross-Functional Teamwork

Drug Development

Ethical Standards

Medical Research

Oncology

Pulmonology

Regulatory Requirements

Research Methodologies

Scientific Leadership

Strategic Leadership

Education

MD or MD/Ph.D.

Job description

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 Thoracic Oncology.

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 to and work collaboratively with the Section Head-to promote the development strategy of the company on the indication of interest.
• Work closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, medical affairs and manufacturing to manage clinical development projects; and assist the Section Head 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 Thoracic Oncology
• 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

Required Skills

Clinical Development, Clinical Judgment, Clinical Medicine, Clinical Research, Clinical Trial Planning, Clinical Trials, Cross-Cultural Awareness, Cross-Functional Teamwork, Drug Development, Ethical Standards, Medical Research, Oncology, Pulmonology, Regulatory Requirements, Research Methodologies, Scientific Consulting, Scientific Leadership, Scientific Research, Strategic Leadership

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:

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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.

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The primary location for this posting is:

USA - New Jersey - Rahway

Where required by law, the compensation range for this role is provided below.

The salary range for the primary location of this role is:

$310,900.00 - $489,400.00

This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of 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 .

Additional location(s)

Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

Additional location(s) Compensation Information

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

Employee Status

Regular

Relocation

Domestic

VISA Sponsorship

No

Travel Requirements

25%

Flexible Work Arrangements

Hybrid

Shift

Not Indicated

Valid Driving License

No

Hazardous Material(s)

n/a

Job Posting End Date

10/28/2026

*A job posting is effective until 11:59:59PM on the day BEFORE -the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID

R381175