Executive Director, Regulatory Liaison
Apply NowCompany: Merck & Co, Inc
Location: Boston, MA 02115
Description:
Job Description
The Executive Director, Companion Diagnostics/ In Vitro Diagnostics, reporting to Vice President, Global Regulatory Affairs and Clinical Safety (GRACS) Oncology Therapeutic Area, is responsible for overseeing the development and implementation of worldwide regulatory strategy for Companion Diagnostics/In Vitro Diagnostic projects within their portfolio. The individual functions with a high degree of independence and provides oversight for assigned products. They directly manage a team of regulatory strategists and are recognized as an expert in Companion Diagnostics/In Vitro Diagnostic development and they provide technical and professional leadership to staff handling multiple projects. Their subject matter expertise is leveraged internally to provide advice to staff and externally via committee representation and consultation. They are also a recognized internal expert for one or more aspects of regulatory policy or geographic regions.
Primary Responsibilities:
Education Requirement:
Required Experience and Skills:
Preferred Experience and Skills:
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 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:
$227,300.00 - $357,900.00
Available 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. A summary of benefits is listed here.
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):
Job Posting End Date:
04/29/2025
*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.
The Executive Director, Companion Diagnostics/ In Vitro Diagnostics, reporting to Vice President, Global Regulatory Affairs and Clinical Safety (GRACS) Oncology Therapeutic Area, is responsible for overseeing the development and implementation of worldwide regulatory strategy for Companion Diagnostics/In Vitro Diagnostic projects within their portfolio. The individual functions with a high degree of independence and provides oversight for assigned products. They directly manage a team of regulatory strategists and are recognized as an expert in Companion Diagnostics/In Vitro Diagnostic development and they provide technical and professional leadership to staff handling multiple projects. Their subject matter expertise is leveraged internally to provide advice to staff and externally via committee representation and consultation. They are also a recognized internal expert for one or more aspects of regulatory policy or geographic regions.
Primary Responsibilities:
- Effectively communicate to (and manage) multiple senior stakeholders in our Research and Development (R&D) Division and Global Human Health (GHH) to bring an awareness of the product/program risks. Collaborate and work effectively across boundaries to enable the timely (proactive) resolution. Demonstrate leadership capabilities to drive an effective conversation at senior levels.
- Oversight and management of regulatory strategists including review of regulatory strategy for respective products as needed.
- Lead complex programs or components thereof of significant value to the company.
- Apply high-level scientific judgment in a variety of highly complex and unprecedented situations
- Review and approve regulatory submissions.
- Review and approve communication materials to be used external to our Company such as press releases for accuracy and consistency of message.
- Review and approve background packages to ensure clarity and comprehensive presentation of issues.
- Review labeling and manage label negotiations with agencies worldwide as appropriate to obtain and maintain optimal labeling consistent with the company core data sheet.
- Participate in regulatory due diligence activities for licensing candidate review.
- Manage assignments for their regulatory liaisons, including resourcing for project assignments.
- Provide technical and professional leadership to staff and conduct all appropriate HR activities such as managing performance, development planning; staffing and related people-management responsibilities for regulatory liaisons within areas of responsibility.
- Develop relationship with external stakeholders (industry and regulators) to understand the current landscape and influence internally to implement rigorous, innovative and science-based approaches to our development and submissions.
- Represent our Company as needed at external initiatives notably with regulatory authorities.
Education Requirement:
- Required: B.S. or M.S. with a minimum of 12 years relevant drug development experience, a majority of which was in Regulatory OR M.D. or PhD or PharmD with a minimum of 7 years relevant drug development experience preferably with 5 years in Regulatory.
- Preferred: M.D. or PhD in biological science, chemistry or related discipline.
Required Experience and Skills:
- Companion Diagnostics/In Vitro Diagnostics regulatory experience required.
- Demonstrated scientific knowledge, writing ability, effective communication and thorough familiarity with worldwide regulatory agencies.
- Outstanding interpersonal, communication and negotiation skills.
- Demonstrated leadership attributes; experienced at building and leading high performing teams or projects; exemplifies corporate and ethical integrity; drives success consistent with company values and priorities.
Preferred Experience and Skills:
- Prior people management experience.
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 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:
$227,300.00 - $357,900.00
Available 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. A summary of benefits is listed here.
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):
Job Posting End Date:
04/29/2025
*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.