Merck Sharp & Dohme
Director, Clinical Research, Immunology
Merck Sharp & Dohme, Rahway, New Jersey, us, 07065
Job Description
The Clinical Director (Principal Scientist) has primary responsibility for 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 study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.
Specifically, the position may be responsible for:
Evaluating pre-clinical and translational work for the purpose of generating clinical development plans 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.
The Clinical Director may:
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/Executive Clinical Director/Vice-President 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 one’s areas of responsibility.
The Clinical Director is responsible for maintaining a strong scientific fund of knowledge by:
Maintaining awareness of scientific developments within one’s 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 related disease areas, 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 one’s competency and to maintain awareness of research activities in one’s 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./PhD.
Required:
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;
Strong interpersonal skills, as well as the ability to work collaboratively in a cross-functional team environment.
Preferred:
Experience in last stage clinical development in Rheumatology, Dermatology or Ophthalmology preferred.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders.
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.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.
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, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day.
The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.
Expected US salary range:$243,500.00 - $383,300.00Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days.
Search Firm Representatives Please Read CarefullyMerck & 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.
Employee Status:
Regular
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:HybridShift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
10/4/2024
Requisition ID: R309355
#J-18808-Ljbffr
The Clinical Director (Principal Scientist) has primary responsibility for 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 study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.
Specifically, the position may be responsible for:
Evaluating pre-clinical and translational work for the purpose of generating clinical development plans 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.
The Clinical Director may:
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/Executive Clinical Director/Vice-President 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 one’s areas of responsibility.
The Clinical Director is responsible for maintaining a strong scientific fund of knowledge by:
Maintaining awareness of scientific developments within one’s 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 related disease areas, 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 one’s competency and to maintain awareness of research activities in one’s 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./PhD.
Required:
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;
Strong interpersonal skills, as well as the ability to work collaboratively in a cross-functional team environment.
Preferred:
Experience in last stage clinical development in Rheumatology, Dermatology or Ophthalmology preferred.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders.
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.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.
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, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day.
The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.
Expected US salary range:$243,500.00 - $383,300.00Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days.
Search Firm Representatives Please Read CarefullyMerck & 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.
Employee Status:
Regular
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:HybridShift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
10/4/2024
Requisition ID: R309355
#J-18808-Ljbffr