MSD
Job Description
Description:
The Translational Sciences & Outsourcing group in the department of Pharmacokinetics, Dynamics, Metabolism and Bioanalytics (PDMB) is seeking a Senior Director to lead the regulated vaccine assay outsourcing (OS) team. The OS function within PDMB is responsible for the oversight of contract research organization (CRO) regulated preclinical/clinical assay method development, qualification/validation, and testing in support of Our Company’s vaccine programs. The Senior Director is a leadership position responsible for the strategic vision, oversight and operational excellence for vaccine bioanalytical outsourcing, ensuring alignment with corporate objectives and regulatory requirements. The Senior Director will oversee a multidisciplinary team of scientists in the development, validation, and execution of bioanalytical methods that support vaccine development programs at external lab partners, while ensuring the highest standards of quality and compliance and fostering a culture of scientific rigor, collaboration, and continuous improvement. The Senior Director’s responsibilities will include establishing departmental goals, managing budgets, and overseeing resource allocation to enhance outsourcing execution and efficiency. The Senior Director will collaborate closely with cross-functional teams, including research and development, regulated bioanalytical, clinical research, regulatory affairs, and quality assurance, to provide scientific leadership and strategic and operational guidance throughout the project lifecycle. Additionally, the Senior Director will play a critical role in mentoring and developing talent within the organization, fostering a culture of professional growth, diversity, innovation, and scientific excellence. This position offers a unique opportunity to influence the development of life-saving vaccines, improving public health and driving advancements in the biopharmaceutical industry.
PLEASE NOTE THAT THIS IS NOT A LABORATORY-BASED POSITION.
Main Responsibilities include, but are not limited to:
Providing scientific and operational leadership to direct reports within the regulated vaccines assay outsourcing group. Leading and managing change initiatives within the group, fostering a culture of innovation and adaptability.
Defining and implementing a strategic vision for the vaccines outsourcing group that aligns with organizational goals. Strong understanding of market trends and regulatory changes that impact bioanalytical practices and drug development.
Driving optimization of internal and external processes aimed at improving operating efficiencies, quality, and compliance. Identifying and integrating innovative bioanalytical techniques and technologies to enhance CRO capabilities and efficiency.
Cross-functional collaboration and engagement with internal and external stakeholders, including regulatory agencies, to facilitate successful project outcomes and build strategic partnerships. Effectively engage and build internal relationships with diverse teams across the organization, including Regulated Bioanalytical, Clinical Research, Regulatory, Procurement, Biostatistics, etc. to ensure Our Company scientific and quality expectations are achieved.
Leading and decision-making in consultation with senior management where necessary and through participation in governance meetings, as relates to vaccine assay strategy and team management.
Managing and overseeing multiple bioanalytical projects simultaneously from initiation to completion, ensuring alignment with development timelines and regulatory requirements.
Mentoring and developing future leaders within the organization, promoting professional growth and scientific excellence. Serve on the OS leadership team to collaborate with other OS leaders on maintaining a strong OS organization with a focus on ensuring scientific excellence and employee development opportunities.
Contract Research Organization (CRO)/vendor relationship management, setting clear expectations and standards for CRO performance and quality to ensure compliance, data quality and integrity, and on-time completion of testing.
Maintaining the highest standards of quality and compliance in all bioanalytical activities, ensuring data integrity and reliability. Establishing performance metrics and driving continuous improvement initiatives to enhance CRO laboratory outcomes. Raising performance or resource concerns to vendor and escalating within Our Company, if performance issue remains unresolved.
Representing Our Company leadership in Site Visits to external lab partners, including data review and compliance assessment against Our Company and regulatory agency expectations.
Establishing and monitoring vaccine outsourcing group’s budget, oversee forecasting efforts aligning with Finance and best Sourcing Operation practices.
Review/approval of master service and project agreements, and working closely with Research Procurement on contracting, CRO onboarding process, etc. Effectively allocate resources across projects to maximize execution and efficiency and to meet organizational goals.
Preparing/reviewing documentation for regulatory agency submissions, ensuring compliance with industry standards. Review/input on study testing protocols, bioanalytical reports, test methods, assay data, etc. where needed.
Expertise in Interpreting complex bioanalytical data and making informed decisions to guide project direction and outcomes. Assisting direct reports with problem-solving and decision making where necessary to resolve issues.
Education Minimum Requirement: PhD in Biology, Cell Biology, Virology, Immunology, Biochemistry or related field with 7+ years of broad scientific experience in immunoassay techniques including ligand binding assays, cell-based functional and neutralization assays, and/or molecular assays, and specializing in vaccines method development and validation, or Master’s degree with 10+ years of experience as above, or Bachelor’s degree with 14+ years of experience as above Required Experience and Skills: Broad experience in bioanalytical development and validation, and quality control (QC) with working knowledge of regulatory agency requirements for operating in a regulated clinical and GLP testing environment. Experience working in a regulated assay testing environment preferred.
An independent scientist with extensive experience in the Drug Development process and demonstrated expertise in vaccine clinical assay development and validation, with a solid understanding of how the data are being used.
Ability to lead a team of direct reports, provide coaching/mentorship, conduct employee development discussions and performance assessments.
Excellent technical, communication (oral and written), interpersonal, and teamwork skills.
Self-motivated with a positive attitude and proven performance record.
Experience with vaccine research and assay development, including broad understanding of the following techniques: Cell-based neutralization assays
Ligand binding assays
PCR/RT-PCR (traditional and real-time)
Experience overseeing implementation of automation and robotics in a regulated testing environment is desirable.
Travel Requirements: 10 - 20% 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”. The salary range for this role is $169,700.00 - $267,200.00 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 employee’s 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
https://jobs.merck.com/us/en/compensation-and-benefits . 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. 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: Domestic
VISA Sponsorship: Yes
Travel Requirements: 25%
Flexible Work Arrangements: Hybrid
Shift: Not Indicated
Valid Driving License: No
Hazardous Material(s): n/a
Required Skills: Analytical Thinking, Analytical Thinking, Assay Development, Bioanalysis, Bioanalytical Assays, Budget Management, Cell-Based Assays, Client Relationship Building, Clinical Research, Confidentiality, Cross-Cultural Awareness, Drug Development, Drug Discovery Development, Immunoassays, Immunochemistry, Immunology, Innovation, Laboratory Information Management System (LIMS), Ligand Binding Assay, Modeling Simulations, People Leadership, Pharmacokinetics, Quality by Design, Regulatory Compliance, Results-Oriented {+ 1 more}
Preferred Skills: Job Posting End Date: 08/28/2025
*A job posting is effective until 11:59:59PM 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.
#J-18808-Ljbffr
Defining and implementing a strategic vision for the vaccines outsourcing group that aligns with organizational goals. Strong understanding of market trends and regulatory changes that impact bioanalytical practices and drug development.
Driving optimization of internal and external processes aimed at improving operating efficiencies, quality, and compliance. Identifying and integrating innovative bioanalytical techniques and technologies to enhance CRO capabilities and efficiency.
Cross-functional collaboration and engagement with internal and external stakeholders, including regulatory agencies, to facilitate successful project outcomes and build strategic partnerships. Effectively engage and build internal relationships with diverse teams across the organization, including Regulated Bioanalytical, Clinical Research, Regulatory, Procurement, Biostatistics, etc. to ensure Our Company scientific and quality expectations are achieved.
Leading and decision-making in consultation with senior management where necessary and through participation in governance meetings, as relates to vaccine assay strategy and team management.
Managing and overseeing multiple bioanalytical projects simultaneously from initiation to completion, ensuring alignment with development timelines and regulatory requirements.
Mentoring and developing future leaders within the organization, promoting professional growth and scientific excellence. Serve on the OS leadership team to collaborate with other OS leaders on maintaining a strong OS organization with a focus on ensuring scientific excellence and employee development opportunities.
Contract Research Organization (CRO)/vendor relationship management, setting clear expectations and standards for CRO performance and quality to ensure compliance, data quality and integrity, and on-time completion of testing.
Maintaining the highest standards of quality and compliance in all bioanalytical activities, ensuring data integrity and reliability. Establishing performance metrics and driving continuous improvement initiatives to enhance CRO laboratory outcomes. Raising performance or resource concerns to vendor and escalating within Our Company, if performance issue remains unresolved.
Representing Our Company leadership in Site Visits to external lab partners, including data review and compliance assessment against Our Company and regulatory agency expectations.
Establishing and monitoring vaccine outsourcing group’s budget, oversee forecasting efforts aligning with Finance and best Sourcing Operation practices.
Review/approval of master service and project agreements, and working closely with Research Procurement on contracting, CRO onboarding process, etc. Effectively allocate resources across projects to maximize execution and efficiency and to meet organizational goals.
Preparing/reviewing documentation for regulatory agency submissions, ensuring compliance with industry standards. Review/input on study testing protocols, bioanalytical reports, test methods, assay data, etc. where needed.
Expertise in Interpreting complex bioanalytical data and making informed decisions to guide project direction and outcomes. Assisting direct reports with problem-solving and decision making where necessary to resolve issues.
Education Minimum Requirement: PhD in Biology, Cell Biology, Virology, Immunology, Biochemistry or related field with 7+ years of broad scientific experience in immunoassay techniques including ligand binding assays, cell-based functional and neutralization assays, and/or molecular assays, and specializing in vaccines method development and validation, or Master’s degree with 10+ years of experience as above, or Bachelor’s degree with 14+ years of experience as above Required Experience and Skills: Broad experience in bioanalytical development and validation, and quality control (QC) with working knowledge of regulatory agency requirements for operating in a regulated clinical and GLP testing environment. Experience working in a regulated assay testing environment preferred.
An independent scientist with extensive experience in the Drug Development process and demonstrated expertise in vaccine clinical assay development and validation, with a solid understanding of how the data are being used.
Ability to lead a team of direct reports, provide coaching/mentorship, conduct employee development discussions and performance assessments.
Excellent technical, communication (oral and written), interpersonal, and teamwork skills.
Self-motivated with a positive attitude and proven performance record.
Experience with vaccine research and assay development, including broad understanding of the following techniques: Cell-based neutralization assays
Ligand binding assays
PCR/RT-PCR (traditional and real-time)
Experience overseeing implementation of automation and robotics in a regulated testing environment is desirable.
Travel Requirements: 10 - 20% 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”. The salary range for this role is $169,700.00 - $267,200.00 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 employee’s 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
https://jobs.merck.com/us/en/compensation-and-benefits . 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. 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: Domestic
VISA Sponsorship: Yes
Travel Requirements: 25%
Flexible Work Arrangements: Hybrid
Shift: Not Indicated
Valid Driving License: No
Hazardous Material(s): n/a
Required Skills: Analytical Thinking, Analytical Thinking, Assay Development, Bioanalysis, Bioanalytical Assays, Budget Management, Cell-Based Assays, Client Relationship Building, Clinical Research, Confidentiality, Cross-Cultural Awareness, Drug Development, Drug Discovery Development, Immunoassays, Immunochemistry, Immunology, Innovation, Laboratory Information Management System (LIMS), Ligand Binding Assay, Modeling Simulations, People Leadership, Pharmacokinetics, Quality by Design, Regulatory Compliance, Results-Oriented {+ 1 more}
Preferred Skills: Job Posting End Date: 08/28/2025
*A job posting is effective until 11:59:59PM 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.
#J-18808-Ljbffr