Principal Scientist, Clinical Research, Immunology

Job Description

The 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

• 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 companys 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 companys 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.

Education

• M.D. D.O. M.D./PhD or D.O./PhD

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:

Preferred Skills:

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.

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 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:

EEOC Know Your Rights

EEOC GINA Supplement

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 anothers thinking and approach problems collectively.

Learn more about your rights including under California Colorado and other US State Acts

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 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 salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees 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 can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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:

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