Job Abstract

Job Description

The Distinguished Scientist, Nonclinical Drug Safety (NDS), Therapeutic Area Leader, Oncology 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 oversee the progression of nonclinical development programs and post-marketing support. The role will include responsibilities in the Oncology Therapeutic Area.

• Providing scientific and strategic oversight for all Oncology 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, as needed, across other areas such as (biology, chemistry, regulatory, clinical, 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 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 and interface with Discovery Program Leaders in NDS, providing scientific and strategic input on discovery projects within the Oncology 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 within the Oncology and/or Immuno-oncology Therapeutic Area.

Education:

• 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 15 years in Toxicology, Immunology, Pharmacology, Pathology or related field with extensive pharmaceutical Drug Development 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 collaborating with and mentoring growth and development of program team representative on diverse array of nonclinical drug safety issues.

• Demonstrated experience and expertise in nonclinical drug development including discovery, early and late development; strong preference for previous experience in Oncology and/or Immuno-oncology drug development as either a program team representative and/or scientific oversight for 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 with ability to develop and deliver clear and concise nonclinical documents and presentations.

• Experience in authoring and critical review of nonclinical sections of relevant nonclinical regulatory documents (IBs, INDs, CTAs, NDAs, BLAs, MAAs, PIP/PSPs, Scientific Advice, weight of evidence risk assessments, regulatory responses etc.).

• Strong commitment developing Compound Leaders; encourages and develops diversity of thought and embraces risk-balanced innovation.

• Strategically involved in development of future leaders in drug development in NDS with depth of experience in regulatory processes, risk assessments and regulatory guidelines related to nonclinical drug development and Good Laboratory Practice (GLP).

• Accountable for delivery for high-quality documents and safety assessments

• Demonstrated experience navigating issues and regulatory requirements for advancing drug development candidates across modalities from preclinical through Phase 3 clinical development, regulatory approvals and/or post-approval commitments.

• Nonclinical drug safety and/or regulatory toxicology experience across oncology, hematology/oncology, immuno-oncology including various modalities (small molecules, mAbs including bispecifics and T-/NK-cell engagers, antibody drug conjugates, etc.).

• Excellent interpersonal and communication skills together with a passion for science balanced with strategic thinking and strong leadership skills with the ability to collaborate, communicate and influence stakeholders to advance on complex nonclinical safety issues while embracing a mindset that strives to achieve robust risk-balanced solutions. 

Preferred Experience and Skills:

• Previous experience in Oncology, Immuno-oncology drug development

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

• Extensive experience on product development team(s)

NOTICE FOR INTERNAL APPLICANTS

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.

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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:

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.

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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. 

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