Job Description
The Science and Regulatory Policy (SRP) team advocates for policy priorities that support the pipeline and portfolio for our Research & Development Division and our company's business goals, developing wider support for our causes and maintaining a strong reputation as a science-led biopharmaceutical innovative leader. We work in partnership with all of the our Research & Development Division divisions to define and implement a prioritized policy and advocacy plan that advances business goals.
The SRP team comprises of four contributing teams:
- Global Regulatory Policy (GRP)
- Data & Advanced Digital Technology Policy (DADTP)
- Evidence Policy, and
- Clinical Research Policy.
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Our SRP team responsibilities include:
- Developing and delivering strategic leadership for policy priorities to support our pipeline and portfolio;
- Advocating for and anticipating policy change that affects our research and development activities worldwide and innovation environment;
- Advising and providing insights for our Research & Development Division senior leadership on critical developments in the global policy environment that impact our pipeline and portfolio;
- Taking leadership for coordinating and aligning policy development and activity across our Research & Development Division, with particularly focus on the Development and Regulatory organizations;
- Leadership for strategy and coordination of our Research & Development Division External Policy relationships to meet priorities;
- Building our company's share of voice and influence extramurally to support the company enterprise policy agenda.
Responsibilities and activities of the Senior Director, Clinical Research Policy
include:
- Leads and is responsible for the Company's Clinical Research Policy and Intelligence operations globally,
- Provides leadership and strategic direction to the Clinical Research Policy team,
- Establishes and drives the clinical research policy priority agenda for the Company and oversees the surveillance and regulatory intelligence measures,
- Supports the Development leadership team advising Development leadership on global clinical research policy issues,
- Serving as a strong subject matter expert in regulations and laws that shape clinical research environments in the United States, including Good Clinical Practice (GCP) and related international standards.
- Proactively monitoring and interpreting the external clinical research environment in the United States to provide a strategic view of emerging issues and identify opportunities to influence the environment favorably for company business and the product portfolio.
- Engaging with key company stakeholders to develop, shape and ensure alignment with the overall company position to respond to upcoming legislation, guidance, and regulatory processes applying to clinical evidence development.
- Working closely with subject matter experts within the company to assess the impact of clinical research policy on the company's products and goals.
- Supporting the team responsible for clinical research policy surveillance and advocacy.
- Driving and shaping policy initiatives and external networking opportunities to maximize the positive impact of the company in the clinical research environment.
- Representing the company on key advocacy topics and maintaining productive relationships with industry staff, health authorities and NGOs.
- Collaborating closely with all SRP teams, Global Public Policy, Federal Policy, Office of Ethics, Clinical Transparency and other key stakeholders within the company on the development and implementation of clinical research policy goals.
- Working closely with the Global Regulatory Policy team to align on clinical research policy efforts in the regions and therapeutic area requirements.
Education minimum required:
- Bachelor's degree is required, preferably in science, health care, public health or health policy or BS in any field accompanied by a master's or doctorate degree in science, health care, public health, health policy, or law
- Doctorate degree and at least 5 years' experience with FDA or other health authority, either directly (working within a health authority) or indirectly (closely interacting with health authority) and preferably in clinical research activities OR
- Master's degree and at least 8 years' experience with FDA or other health authority, either directory (working within a health authority) or indirectly (closely interacting with health authority) and preferably in clinical research activities OR
- Bachelor's degree and at least 10 years' experience with FDA or other health authority, either directly (working within a health authority) or indirectly (closely interacting with health authority) and preferably in clinical research activities
Required experience and skills:
- Experience directly managing people and/or leadership experience in managing teams, projects or programs or directing the allocation of resources
- Proven capability in acting as a credible, influential and respected spokesperson able to convey complex messages, trends & insight
- Deep understanding of the US clinical research environment, the latest regulations and guidance related to clinical research and data, with sound knowledge of intelligence tools and methods
- Strong relationship management and interpersonal skills with superb written and oral and communication skill
- Proven success at stakeholder engagement across organizational levels and boundaries with ability to manage highly complex situations and engender trust when dealing with sensitive issues
- Ability to fully demonstrate leadership skills, driving results and building talent
- Ability to thrive in a cross-functional team environment with a global mindset
- Ability to travel internationally on a quarterly basis
- Excellent command of English (written and spoken)
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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. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
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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:
$164,800.00 - $259,400.00
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:
01/15/2025
*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.
Requisition ID:R325865