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Job Details

Merck & Co, Inc

Nonclinical Drug Safety (NDS), Therapeutic Area Leader, Infectious Disease Program Development - Distinguished Scientist

Business Development

Program Specialist


West Point, Pennsylvania, United States

Job Description

The Distinguished Scientist, Nonclinical Drug Safety (NDS) Therapeutic Area is a scientific executive leader with responsibilities that include but are not limited to the following:

  • The role serves as a Therapeutic Area Leader in NDS within the specified therapeutic area(s) of interest to our company to oversee the progression of nonclinical development programs and post-marketing support. The role will include responsibilities in the Infectious Disease (Antivirals/Antibacterials/Antifungals/Antiparasitics, etc.) Therapeutic Area.

  • Providing scientific and strategic oversight for all development candidates within this area, through close collaboration with Program Coordinators and Compound Leaders (program team representatives) from various functional areas within NDS, Preclinical Development and, as needed, across other areas such as (biology, chemistry, clinical, etc) or external partners.

  • Provide strong drug development mentorship and partnership in problem solving with Compound Leaders on diverse time critical drug development matters including design of nonclinical program/ studies to appropriately support clinical trials as well as ongoing oversight of nonclinical safety and development strategy, successful issue identification and resolution.

  • Responsible for high-quality nonclinical risk assessments and regulatory documentation that support solid submission components including clear and concise descriptions of experimental details, interpretations and robust risk assessments for IBs, CTAs, IND, NDA, MAA, regulatory responses and other legal/scientific documents to support global clinical trials and registration.

  • Close collaboration with the Infectious Disease Discovery group and interface with Discovery Program Leaders in NDS, providing scientific and strategic input on discovery projects within this therapeutic area.

  • Contributes to global nonclinical development strategy through scientific publication and/or participation on external consortia and collaborations and proactively initiates and leads internal cross-departmental initiatives to improve policies, procedures, and/or strategic direction to ensure our company is a leader in nonclinical drug development.

  • The incumbent may also serve as a Compound Leader for their own development compound(s) and may be responsible for overseeing and/or conducting NDS due diligence reviews for in-licensing compounds within the Infectious Disease Therapeutic Area.


  • PhD, DVM, and/or MD Degree with graduate and/or post-graduate work and/or residency training in Toxicology, Pharmacology, Pathology, or a related field.

Required Experience and Skills:

  • Minimum experience of 10 years in Toxicology, Pharmacology, Pathology or related field with either extensive pharmaceutical Program Team experience and demonstrated expertise in nonclinical drug development and/or extensive regulatory experience with a Health Authority in a related field.

  • Previous experience supervising and/or mentoring program team representatives

  • Solid experience with regulatory processes, risk assessments and ICH guidelines and Good Laboratory Practice (GLP).

  • Demonstrated experience and expertise in nonclinical drug development including discovery, development through post-marketing; strong preference for previous experience in infectious disease drug development as either a program team representative and/or scientific oversight for this Therapeutic Area.

  • Strong scientific acumen, passionate and persistent with a track-record of success in various phases of drug development.

  • Strong leadership skills and ability to work to maintain effective interactions in matrixed environment; ability to collaboratively influence strategic direction; leadership style creates a balanced culture of mentorship, empowerment and accountability achieving talent growth and program success.

  • Efficient organizational skills and excellent verbal and written communication skills.

  • Experience in writing nonclinical sections of relevant nonclinical regulatory documents (IBs, briefing book, BLA’s, NDA’s, regulatory responses etc).

Preferred Experience and Skills:

  • Previous experience in Infectious Disease drug development

  • Experience across multiple modalities

  • Well recognized in area of expertise; significantly contributed to global regulatory strategy through scientific publication and/or participation on external consortia/collaborations

  • Previous experience on product development team(s)

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

Who we are …

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for …

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.


In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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.

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Know Your Rights

EEOC GINA Supplement​

Pay Transparency Nondiscrimination

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. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Under New York City, Washington State and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. 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 salary range:

$193,440.00 - $304,500.00

Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here.

Learn more about your rights, including under California, Colorado and other US State Acts

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:



No relocation

VISA Sponsorship:


Travel Requirements:


Flexible Work Arrangements:

Hybrid, On-Site


Not Indicated

Valid Driving License:


Hazardous Material(s):


Requisition ID:R229709