Senior Principal Scientist, Clinical Research, Immunology

MSD•Rahway, NJ

5d•Hybrid

About The Position

The Senior Director (Sr. 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 Senior 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 Senior 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 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 Executive Director 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 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 drugs in Immunology. Establishing collaborative relationships with external experts in Rheumatology, Gastroenterology, Dermatology, Pulmonary, or rare 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 Senior 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.

Requirements

M.D., D.O., M.D./Ph.D, or D.O./PhD.
Experience in the design and/or execution of phase 2 or 3 clinical trials specifically in Immunology
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
Strong interpersonal skills, as well as the ability to work collaboratively in a cross-functional team environment.
Clinical Development
Clinical Documentation
Clinical Immunology
Clinical Judgment
Clinical Medicine
Clinical Research Management
Clinical Sciences
Clinical Studies
Clinical Trial Development
Data Analysis
Drug Development
Gastroenterology
Hiring
Ophthalmology
Rare Diseases
Scientific Consulting
Strategic Planning

Nice To Haves

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 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: 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 another’s 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 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):

Responsibilities

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
Participation in internal and joint internal/external research project teams relevant to the development of new compounds
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 Executive Director 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.
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, Gastroenterology, Dermatology, Pulmonary, or rare 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.
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.

Benefits

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.
annual bonus
long-term incentive

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