Job Description

Position Description:

Associate Director, Project Management

As an Associate Director in the Nonclinical Drug Safety (NDS) Program Coordination and Planning group, the incumbent will be responsible for partnering with Discovery Program Leaders (Discovery Team Reps), Compound Leaders (Early Development and Product Development Team Reps), and Therapeutic Area Leaders to support the technical, operational, and scientific aspects of drug development in NDS.

The successful candidate will work cross-functionally in a highly matrixed organization to ensure successful and efficient coordination of nonclinical safety data in support of our Research & Development Division, discovery, and development programs.

Primary responsibilities include:

• Ensuring scientifically rigorous study designs are developed, requested, and communicated within NDS and associated study scheduling systems.

• Interfacing with Operations - Project Planning (NDS) and impacted laboratory/operational areas on changes in study designs or timelines.

• Coordinate collaboration and interactions with Central Pharmacy (NDS) and other areas in Discovery, Preclinical, and Translational Medicine (DPTM) for drug supply, allocation of materials, formulation, and stability matters.

• Collaborate with key stakeholders to determine drug requirements and availability for NDS studies.

• Request, track, and assist with the development of regulatory packages including but not limited to PSURs/DSURs, IBs, IND/IMPDs, and WMAs.

• Tracking regulatory agency comments and resolutions.

• Partnering with program teams and NDS stakeholders to provide monthly tracking in a pipeline management tool for the status, issues, and resolution plans on all active programs.

• Highlighting and ensuring that program issues are appropriately escalated to NDS management.

• Standardizing and optimizing procedures and processes involved in compound development within NDS and across DPTM.

• Training new Discovery Program Leaders (DPLs) and Compound Leaders (CLs) in particular components of drug discovery and development.

• Leading independent projects/assignments related to nonclinical drug discovery and development.

Position Qualifications:

Education Minimum Requirement:

• BA/BS or equivalent in biological sciences, chemical or pharmaceutical/medical/regulatory sciences required.

• Preferred: MA/MS/MBA in the above sciences, business, or project management accreditation.

Required Experience and Skills:

• At least 5 years of experience in NDS or similar function.

• Proven understanding of drug discovery and development processes, particularly as it relates to nonclinical aspects of discovery and development as well as familiarity with the broad scope of safety assessment studies that support drug discovery, clinical development, and marketing approval.

• Strong evidence of strong cross-functional collaborative skills and ability to thrive in a matrixed work environment.

• Excellent communication skills, including experience with meeting facilitation and presentations.

• Ability to execute independent projects, and balance activities for multiple projects simultaneously.

• Capacity and flexibility to immediately and independently take on new urgent assignments, balance other work accordingly, and interface with other areas as needed to accomplish the assignment.

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.

Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)

Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

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 (https://survey.sogosurvey.com/r/aCdfqL) 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:

EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf)

EEOC GINA Supplement​

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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, 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”.

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:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

N/A

Requisition ID: R290366