Job Description

　　The Nonclinical Drug Safety (NDS) Therapeutic Area Leader responsibilities include 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 Immunology Therapeutic Area.Providing scientific and strategic oversight for Immunology and/or Immuno-oncology development candidates through close collaboration with Program Coordinators and Compound Leaders (program team representatives) from various functional areas within NDS, Preclinical Development and ensure strong partnership across other areas such as (biology, chemistry, regulatory, clinical, CMC, etc).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 development strategy and eye towards successful nonclinical drug development issue identification and timely 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 through global registration and post marketing.Close collaboration and interface with Discovery Program Leaders in NDS, providing scientific and strategic input on emerging discovery projects within the Immunology 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 his/her own development compound(s) and may be responsible for overseeing and/or conducting NDS due diligence reviews for in-licensing compounds.

　　Required:

　　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 experience of 8 years in Toxicology, Immunology, Pharmacology, Pathology or related field with either pharmaceutical Program Team experience and demonstrated expertise in nonclinical drug development and/or regulatory experience with a Health Authority in a related field.Experience collaborating with 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, early and late development; strong preference for previous experience in Immunology and/or Immuno-oncology drug development as either a program team representative and/or scientific oversight for either of these Therapeutic Areas.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:

　　Previous experience in Immunology, Immuno-oncology drug developmentExperience across multiple modalitiesDemonstrated leadership in area of expertise; experienced in global regulatory strategy through scientific publication and/or participation on external consortia/collaboration.Previous experience on product development team(s)

　　NOTICEFORINTERNALAPPLICANTS

　　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 separationpackage, 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.

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　　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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　　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, generally Tuesday, Wednesday and either Monday or 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".

　　Under New York State, Colorado State, 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:

　　$159,200.00 - $250,700.00

　　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.

　　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:

　　Shift:

　　Valid Driving License:

　　Hazardous Material(s):

　　Requisition ID:R265262