Hispanic Alliance for Career Enhancement
Senior Principal Scientist, Clinical Research, HIV
Hispanic Alliance for Career Enhancement, Rahway, New Jersey, us, 07065
Job Description
Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state‑of‑the‑art technology and applying rigorous scientific and ethical standards. Since 1985, our company has been engaged in research and development efforts in the prevention and treatment of HIV. Over the years, our scientists have made significant discoveries that changed the way HIV is treated. Through clinical trials we ensure that our existing and pipeline products are developed to produce safe, effective, and innovative medicines, and we work with cross‑functional colleagues in Global Medical and Scientific Affairs and Global Policy to ensure timely and equitable access to our medicines.
The Senior Principal Scientist has primary responsibility for protocol development and medical/scientific oversight of clinical research studies involving investigational or marketed drugs in the HIV section of the infectious diseases therapeutic area. The individual will participate in all phases of clinical trial process (mainly Phase 2–3) including study design, medical monitoring, and medical/scientific interpretation of study analyses, regulatory reporting, and publication. The individual will apply an in‑depth understanding of HIV and drug pharmacology to the infectious disease therapeutic area’s clinical development strategy and the implementation of short and long‑term research objectives. They will provide internal scientific leadership for cross‑functional areas supporting clinical development and external leadership through interaction with key scientific leaders.
Responsibilities
Planning clinical trials (design, operational plans) based on the clinical development strategies for investigational or marketed HIV drugs
Monitoring and managing the conduct of ongoing or new clinical trials
Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, and publications
Participating in internal and joint internal/external research project teams relevant to the development of investigational drugs, and the further study of marketed drugs.
Scientific Knowledge Maintenance
Maintaining awareness of scientific developments within their area of expertise, including new scientific findings and research methodologies
Establishing communications with prominent clinical investigators in their particular field of interest, particularly those scientifically and operationally strong investigators who can assist in the development of our company's investigational and marketed drugs
Attending appropriate scientific meetings to maintain their competency and to maintain awareness of research activities in their area of responsibility.
Goals and Activities
Author detailed development documents and presentations for internal and external audiences
Author scientific publications
Facilitate collaborations with external researchers around the world
Travel on company business up to about 10% of the time to manage future or ongoing clinical research projects.
Qualifications Education:
MD or MD/PhD with demonstrated expertise in infectious diseases; eligibility for medical licensure and board certification desirable
Requirements:
Industry experience in clinical research and drug development (at least 5 years)
Demonstrated success in overseeing clinical studies and protocols
Demonstrated record of scientific scholarship and achievement
Excellent communication skills, both verbal and written
Strong interpersonal skills, as well as the ability to function in a team environment and leadership experience
Preferred:
Background in antiviral clinical research and HIV drug development
Prior experience with registrational trials and filing with major health authorities
Required Skills Clinical Development, Clinical Judgment, Clinical Medicine, Clinical Research Management, Clinical Trial Development, Clinical Trials, Data Analysis, Drug Development, HIV Prevention, Infectious Disease, Infectious Disease Research, Intellectual Curiosity, Interdisciplinary Problem Solving, Medical Research, Pharmacovigilance, Regulatory Compliance, Regulatory Reporting, Scientific Leadership, Scientific Publications, Scientific Research, Strategic Planning, Vaccine Research, Vaccinology
Preferred Skills Current Employees apply HERE
Current Contingent Workers apply HERE
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”.
Salary The salary range for this role is $276,600.00 – $435,400.00. The successful candidate will be eligible for annual bonus and long‑term incentive, if applicable.
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. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.
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 for this position is stated on this posting.
Residency Restrictions 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 Ange‑les’ Fair Chance Initiative for Hiring Ordinance.
Search Firm Representatives Please Read Carefully Merck & Co., Inc., 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.
Other Job Details Employee Status:
Regular
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Not Applicable
Shift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
12/1/2025
*A job posting is effective until 11:59:59 PM 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.
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 US State Acts.
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.
#J-18808-Ljbffr
Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state‑of‑the‑art technology and applying rigorous scientific and ethical standards. Since 1985, our company has been engaged in research and development efforts in the prevention and treatment of HIV. Over the years, our scientists have made significant discoveries that changed the way HIV is treated. Through clinical trials we ensure that our existing and pipeline products are developed to produce safe, effective, and innovative medicines, and we work with cross‑functional colleagues in Global Medical and Scientific Affairs and Global Policy to ensure timely and equitable access to our medicines.
The Senior Principal Scientist has primary responsibility for protocol development and medical/scientific oversight of clinical research studies involving investigational or marketed drugs in the HIV section of the infectious diseases therapeutic area. The individual will participate in all phases of clinical trial process (mainly Phase 2–3) including study design, medical monitoring, and medical/scientific interpretation of study analyses, regulatory reporting, and publication. The individual will apply an in‑depth understanding of HIV and drug pharmacology to the infectious disease therapeutic area’s clinical development strategy and the implementation of short and long‑term research objectives. They will provide internal scientific leadership for cross‑functional areas supporting clinical development and external leadership through interaction with key scientific leaders.
Responsibilities
Planning clinical trials (design, operational plans) based on the clinical development strategies for investigational or marketed HIV drugs
Monitoring and managing the conduct of ongoing or new clinical trials
Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, and publications
Participating in internal and joint internal/external research project teams relevant to the development of investigational drugs, and the further study of marketed drugs.
Scientific Knowledge Maintenance
Maintaining awareness of scientific developments within their area of expertise, including new scientific findings and research methodologies
Establishing communications with prominent clinical investigators in their particular field of interest, particularly those scientifically and operationally strong investigators who can assist in the development of our company's investigational and marketed drugs
Attending appropriate scientific meetings to maintain their competency and to maintain awareness of research activities in their area of responsibility.
Goals and Activities
Author detailed development documents and presentations for internal and external audiences
Author scientific publications
Facilitate collaborations with external researchers around the world
Travel on company business up to about 10% of the time to manage future or ongoing clinical research projects.
Qualifications Education:
MD or MD/PhD with demonstrated expertise in infectious diseases; eligibility for medical licensure and board certification desirable
Requirements:
Industry experience in clinical research and drug development (at least 5 years)
Demonstrated success in overseeing clinical studies and protocols
Demonstrated record of scientific scholarship and achievement
Excellent communication skills, both verbal and written
Strong interpersonal skills, as well as the ability to function in a team environment and leadership experience
Preferred:
Background in antiviral clinical research and HIV drug development
Prior experience with registrational trials and filing with major health authorities
Required Skills Clinical Development, Clinical Judgment, Clinical Medicine, Clinical Research Management, Clinical Trial Development, Clinical Trials, Data Analysis, Drug Development, HIV Prevention, Infectious Disease, Infectious Disease Research, Intellectual Curiosity, Interdisciplinary Problem Solving, Medical Research, Pharmacovigilance, Regulatory Compliance, Regulatory Reporting, Scientific Leadership, Scientific Publications, Scientific Research, Strategic Planning, Vaccine Research, Vaccinology
Preferred Skills Current Employees apply HERE
Current Contingent Workers apply HERE
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”.
Salary The salary range for this role is $276,600.00 – $435,400.00. The successful candidate will be eligible for annual bonus and long‑term incentive, if applicable.
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. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.
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 for this position is stated on this posting.
Residency Restrictions 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 Ange‑les’ Fair Chance Initiative for Hiring Ordinance.
Search Firm Representatives Please Read Carefully Merck & Co., Inc., 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.
Other Job Details Employee Status:
Regular
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Not Applicable
Shift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
12/1/2025
*A job posting is effective until 11:59:59 PM 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.
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 US State Acts.
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.
#J-18808-Ljbffr