New · posted Nov 8
Merck · Pharmaceuticals
Sr. Principal Scientist, Nonclinical Drug Safety
- West Point, PA +1 more
- Hybrid
- Full-time
- Senior & Principal
The role
The Nonclinical Drug Safety (NDS) Therapeutic Area Leader (TAL) is a senior scientific leader responsible for advancing the vision and goals of NDS and our company as an industry leader in drug development, product registration, and post-marketing support.
Responsibilities include the following:
- Serve as the NDS Therapeutic Area Leader for Immunology, overseeing the progression of nonclinical development programs and post-marketing support within the therapeutic area. The role requires strong scientific acumen in immunology, a deep understanding of regulatory expectations for immunology programs, and the ability to rapidly integrate complex scientific concepts into sound development strategies.
- Deliver high-quality nonclinical strategies, risk assessments, and regulatory submissions that support global clinical development, product registration, and post-marketing commitments, while helping shape the external scientific and regulatory environment through engagement with health authorities, consortia, and scientific organizations.
- Provide scientific and strategic oversight for Immunology candidates through close collaboration with Program Coordinators, Discovery Preclinical Leaders, Compound Leaders, and scientists across NDS and/or Preclinical Development, while ensuring strong partnership with key Research and Development Division functions, including Discovery, chemistry, regulatory affairs, translational medicine, clinical development, and CMC.
- Demonstrate situational leadership and innovative problem-solving, with impact beyond Program Development, by proactively identifying potential program issues and guiding Compound Leaders through ambiguity and complexity to achieve timely, risk-balanced resolution.
- Maintain a strong commitment to the development of Compound Leaders and Discovery Program Leaders through active coaching, mentoring, and scientific leadership.
- Foster a leadership culture that balances coaching, empowerment, accountability, of thought, and talent development to enable both individual growth and program success.
- Ensure strategic planning across Immunology programs and proactively identify resource needs, prioritization considerations, and emerging risks within the therapeutic area.
- Strategically influence nonclinical drug safety considerations for Immunology programs by providing drug development mentorship and partnering with Compound Leaders on time-critical matters, including nonclinical program design and toxicology study design, weight-of-evidence risk assessments, science-based waiver strategies, and integrated safety development plans that support clinical trials, global registration, and timely resolution of nonclinical development issues.
- Be accountable for high-quality nonclinical risk assessments and regulatory documentation, including clear descriptions of experimental design and results, scientifically robust interpretations, and concise risk assessments for Investigator Brochures, CTAs, INDs, NDAs, BLAs, MAAs, regulatory responses, and other legal or scientific documents supporting global clinical trials, registration, and post-marketing activities.
- Collaborate closely with Discovery Program Leaders in NDS to provide scientific and strategic input on emerging discovery projects within the Immunology therapeutic area.
- Contribute to global nonclinical development strategy through scientific publications, external consortia, and cross-industry collaborations, and proactively lead internal cross-departmental initiatives to improve policies, procedures, and strategic direction to maintain our company's leadership in nonclinical drug development.
- May serve as a Compound Leader for assigned development compounds and may oversee or conduct NDS due diligence reviews for in-licensing opportunities relevant to the Immunology therapeutic area.
- Be recognized for immunology expertise and contribute to our company's external scientific and regulatory reputation.
What you need
Required Education, Experience, and Skills
- PhD, DVM, and/or MD degree with graduate and/or post-graduate work and/or residency training in Toxicology, Immunology, Pharmacology, Pathology, or a related field.
- Minimum of 12 years of experience in toxicology, immunology, pharmacology, pathology, or a related field, with pharmaceutical program team experience and demonstrated expertise in nonclinical drug development and/or relevant regulatory experience with a health authority.
- Demonstrated experience collaborating with and mentoring program team representatives.
- Solid experience with regulatory processes, nonclinical risk assessments, ICH guidelines, and Good Laboratory Practice (GLP) requirements.
- Demonstrated expertise in nonclinical drug development across discovery, early development, and late development, with a strong preference for relevant graduate training in immunology and/or substantial experience providing program team representation or scientific oversight for immunology programs.
- Strong scientific acumen, intellectual curiosity, persistence, and a demonstrated track record of success across multiple phases of drug development.
- Strong leadership skills and the ability to build effective partnerships in a matrixed environment; demonstrated ability to collaboratively influence strategic direction and foster a culture of mentorship, empowerment, accountability, talent growth, and program success.
- Excellent organizational skills and strong verbal and written communication capabilities, with the ability to develop and deliver clear, concise, and scientifically rigorous nonclinical documents and presentations.
- Experience authoring and critically reviewing nonclinical sections of regulatory documents, including Investigator Brochures, briefing books, INDs, CTAs, NDAs, BLAs, MAAs, regulatory responses, and related scientific or legal documents.
Required Skills
Cell Line Engineering, Clinical Judgment, Drug Development, Human Health Risk Assessment, Innovative Thinking, Mentorship, Omics Technologies, Pharmacodynamics, Pharmacokinetics, Product Registrations, Project Leadership, Risk Assessments, Strategic Planning, Toxicity Studies, Toxicology
Travel Requirements
10%
Valid Driving License
No
Preferred Experience and Skillsnice to have
- Experience in immunology and/or immuno-oncology drug development.
- Experience supporting nonclinical development across multiple therapeutic modalities.
- Demonstrated leadership in an area of scientific expertise, with experience influencing global regulatory strategy through scientific publication, external consortia, or cross-industry collaboration.
- Previous experience coaching project team representative with varying skill sets and serving on or providing strategic oversight to product development teams.
- Supported programs that have advanced to and/or achieved BLA or WMA
Pay and benefits
$191,000 – $300,000 a year
Employer providedAdditional location(s) Compensation Information
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
Medical, dental and vision insurance
401(k) retirement benefits
Paid holidays
Vacation
Sick days
Annual bonus and long-term incentive
Where you'll work
West Point, PA +1 moreHybridOpen in Maps (opens in a new tab)
Also posted for: Rahway, NJ
More jobs in West Point, PA +1 moreWorking conditions
1st - Day
Hazardous Material(s)
N/A
Employee Status
Regular
Relocation
Domestic
VISA Sponsorship
Yes
Flexible Work Arrangements
Hybrid
Job Posting End Date
11/13/2026
*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.
Equal opportunity, accessibility and legal noticesMerck's statements, word for word
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:
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
The primary location for this posting is:
USA - Pennsylvania - West Point
Where required by law, the compensation range for this role is provided below.
The salary range for the primary location of this role is:
$190,800.00 - $300,300.00
This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of 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.
Additional location(s): Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.
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.
Job intelligence
The context around this role
Live data · November 8, 2026
Salary intelligence
How the pay compares
This role's midpoint is 79% above the US median for Regulatory Affairs roles at this level.
This roleEmployer provided
Senior & Principal roles in the US36 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $191,000 | — | $300,000 |
| All US (middle half) | $114,375 | $137,500 | $153,875 |
This role: Merck's own published range. Comparisons: the base pay employers published on open Regulatory Affairs roles at the same level on Regulatory Jobs, November 8, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Affairs
The general path across 173 open Regulatory Affairs roles on Regulatory Jobs, with the titles they carry most. Not Merck's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 34 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership19
- Clinical trial conduct8
- Documentation and SOPs5
- Quality systems and risk5
- Regulatory submissions4
- Investigations and CAPA2
- GMP and compliance1
- Lab testing and methods1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Regulatory Affairs work in pharmaceuticals, led by the three this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Part 312(official source, opens in a new tab)Investigational New Drug applications and sponsor duties in drug trialsNamed in the posting
- FDA21 CFR Part 314(official source, opens in a new tab)Applications for FDA approval to market a new drug (NDA and ANDA)Named in the posting
- FDA21 CFR Part 58 (GLP)(official source, opens in a new tab)Good laboratory practice for nonclinical laboratory studiesNamed in the posting
- ICHICH M4 (CTD)(official source, opens in a new tab)The Common Technical Document: how a registration dossier is organized
- EUDirective 2001/83/EC(official source, opens in a new tab)The EU code for medicinal products for human use: authorization, labeling, pharmacovigilance
- FDAFDA eCTD(official source, opens in a new tab)The electronic Common Technical Document format for drug and biologic submissions
- FDA21 CFR Part 201(official source, opens in a new tab)FDA labeling requirements for drugs, including prescribing information
- FDAFDA expedited programs(official source, opens in a new tab)Fast track, breakthrough therapy, accelerated approval and priority review
- FDA21 CFR 314.70(official source, opens in a new tab)Supplements and other changes to an approved application (post-approval CMC changes)
- EURegulation (EC) 1234/2008(official source, opens in a new tab)EU variations to the terms of a marketing authorization
- ICHICH E6(R3) good clinical practice(official source, opens in a new tab)The international standard for the design, conduct and reporting of clinical trials
- FDA21 CFR 314.80 and 600.80(official source, opens in a new tab)Postmarketing reporting of adverse drug and biologic experiences
- FDAFDA Electronic Submissions Gateway(official source, opens in a new tab)The agency-wide gateway for receiving electronic regulatory submissions
- Health CanadaCanada Food and Drug Regulations(official source, opens in a new tab)Health Canada's regulations for drugs, including GMP (Part C, Division 2)
- MHRAUK MHRA(official source, opens in a new tab)The UK regulator of medicines and medical devices, including UKCA marking
- PMDAJapan PMDA(official source, opens in a new tab)Japan's Pharmaceuticals and Medical Devices Agency
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Merck on Regulatory Jobs
- 37
- Open roles
- 37
- Distinct roles
- 8
- Locations
By discipline
- Clinical20 54%
- Quality11 30%
- Regulatory6 16%
By level
- Director25 68%
- Senior & Principal6 16%
- Associate & Specialist5 14%
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Sr. Principal Scientist, Nonclinical Drug Safety at Merck
Applications close November 13. $191K–$300K a year, employer provided.