Ccrps
Job Description
The
Clinical Director (Principal Scientist)
has primary responsibility for 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.
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.
Additional Leadership
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 of internal and external expert opinion on scientific questions relevant to his/her areas of responsibility.
Scientific Knowledge & Collaboration
Maintaining awareness of scientific developments within his/her area of expertise, including new scientific findings and 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 competence and keep up to date on research activities relevant to his/her area of responsibility.
Project & Documentation
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 percent (20%) 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 five (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 and ability to work collaboratively in a cross‑functional team environment.
Required Skills Allergy and Immunology, Clinical Development, Clinical Immunology, Clinical Investigations, Clinical Medicine, Clinical Research, Clinical Trial Planning, Clinical Trials, Clinical Trial Support, Cross‑Functional Teamwork, Immunogenicity Assays, Intellectual Curiosity, New Technology Integration, Pulmonology, Respiratory Treatments, Scientific Consulting, Strategic Planning.
Preferred Skills Preferred skills not listed.
Eligibility U.S. and Puerto Rico Residents Only.
Our company is committed to inclusion; please click here if you need an accommodation.
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.
EEO Statement 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. Learn more about your rights, including under California, Colorado and other U.S. State Acts.
Hybrid Work Model Effective September 5, 2023, employees in office‑based positions in the U.S. will be working a hybrid model consisting of three total days on‑site per week, Monday to Thursday, with Friday designated as a remote working day, unless business critical tasks require an on‑site presence.
Compensation Salary range: $250,800.00 – $394,800.00. Eligible for annual bonus and long‑term incentive. Benefits include medical, dental, vision healthcare and other insurance benefits, 401(k), paid holidays, vacation, compassionate and sick days.
Application You can apply for this role through https://jobs.merck.com/us/en or via the Workday Jobs Hub if you are a current employee. The application deadline is stated on this posting.
Legal Search Firm Representatives are not accepted for this position. Merck & Co., Inc. does not accept unsolicited assistance from search firms for employment opportunities.
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Clinical Director (Principal Scientist)
has primary responsibility for 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.
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.
Additional Leadership
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 of internal and external expert opinion on scientific questions relevant to his/her areas of responsibility.
Scientific Knowledge & Collaboration
Maintaining awareness of scientific developments within his/her area of expertise, including new scientific findings and 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 competence and keep up to date on research activities relevant to his/her area of responsibility.
Project & Documentation
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 percent (20%) 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 five (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 and ability to work collaboratively in a cross‑functional team environment.
Required Skills Allergy and Immunology, Clinical Development, Clinical Immunology, Clinical Investigations, Clinical Medicine, Clinical Research, Clinical Trial Planning, Clinical Trials, Clinical Trial Support, Cross‑Functional Teamwork, Immunogenicity Assays, Intellectual Curiosity, New Technology Integration, Pulmonology, Respiratory Treatments, Scientific Consulting, Strategic Planning.
Preferred Skills Preferred skills not listed.
Eligibility U.S. and Puerto Rico Residents Only.
Our company is committed to inclusion; please click here if you need an accommodation.
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.
EEO Statement 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. Learn more about your rights, including under California, Colorado and other U.S. State Acts.
Hybrid Work Model Effective September 5, 2023, employees in office‑based positions in the U.S. will be working a hybrid model consisting of three total days on‑site per week, Monday to Thursday, with Friday designated as a remote working day, unless business critical tasks require an on‑site presence.
Compensation Salary range: $250,800.00 – $394,800.00. Eligible for annual bonus and long‑term incentive. Benefits include medical, dental, vision healthcare and other insurance benefits, 401(k), paid holidays, vacation, compassionate and sick days.
Application You can apply for this role through https://jobs.merck.com/us/en or via the Workday Jobs Hub if you are a current employee. The application deadline is stated on this posting.
Legal Search Firm Representatives are not accepted for this position. Merck & Co., Inc. does not accept unsolicited assistance from search firms for employment opportunities.
#J-18808-Ljbffr