Principal Scientist (Director), Clinical Research, Immunology

Merck; Upper Gwynedd Township (Montgomery County); Hybrid; USD 256,000 - 403,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement benefits

Paid holidays

Vacation

Sick days

Job summary

Merck is seeking a Clinical Director (Principal Scientist) to lead strategic planning and direction of late-stage immunology clinical development, including INDs, study design, execution, and regulatory filings.

The role involves supervising clinical scientists, collaborating with regulatory, statistics, manufacturing, and commercial teams, and guiding investigators worldwide to advance investigational drugs in rheumatology. Travel ~20% with a hybrid work arrangement.

Qualifications

• Minimum of 5 years of clinical and/or development experience in academia, clinical medicine, or corporate clinical development.
• Demonstrated record of scientific scholarship and achievement.
• Prior experience in design and execution of phase 2 or 3 clinical trials in rheumatologic diseases is preferred.

Responsibilities

• Supervise Clinical Scientists in executing clinical studies.
• Collaborate with cross-functional teams (regulatory, statistics, manufacturing, commercial).
• Develop clinical development strategies for investigational drugs and plan trials.
• Monitor and manage ongoing or new clinical trials.
• Analyze clinical findings to support safety, efficacy, and regulatory submissions.

Skills

Clinical Development

Clinical Research

Clinical Trial Planning

Cross-Functional Teamwork

Immunology

Rheumatology

Education

MD/DO, MD/PhD, or DO/PhD

Job description

Job Description

Clinical Director (Principal Scientist) has primary responsibility for the strategic planning and directing clinical research activities involving investigational compounds in Immunology. With a focus on late-stage development, the Clinical Director will manage the entire cycle of clinical development, including determination of appropriate disease indications to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication.

Specifically, The Clinical Director May Be Responsible For

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


• Providing clinical development support of business development assessments of external opportunities to grow the Immunology Pipeline


• Developing clinical development strategies for investigational drugs and 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 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

The Clinical 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, Associate Vice-President/Vice-President and Product Development Team Lead 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 his/her areas of responsibility.

The Clinical 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 drugs in Immunology


• Establishing collaborative relationships with external experts in Rheumatology diseases, particularly those whose research focus and expertise can inform and assist the evaluation of the company's investigational 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 Clinical Director May

• Author 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., D.O., M.D./Ph.D, or D.O./Ph.D.

Required Education And Experience

• Minimum of 5 years of clinical and/or development experience (academia, clinical medicine, and/or corporate clinical development).


• Demonstrated record of scientific scholarship and achievement


• Prior experience in design and execution of phase 2 or 3 clinical trials in rheumatologic diseases is preferred


• Strong interpersonal skills, as well as the ability to work collaboratively in a cross-functional team environment

Required Skills

Clinical Development, Clinical Research, Clinical Trial Planning, Cross-Functional Teamwork, Immunology, Rheumatology

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.

Requirements

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 salary range for this role is

$255,800.00 - $402,700.00

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.

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:

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

• 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.