Associate Director, Clinical Supplies Project Manager

Job Description

The Global Clinical Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full our company's Research Laboratories portfolio of clinical trials. GCS is accountable for the planning, sourcing, labeling, packaging and delivery of clinical supplies to clinical sites globally. The GCS Planning (Planning) organization is the key interface between clinical development teams and the operational/executional arms within the business.

The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS point of contact representing the GCS Planning organization to customers both internal and external to GCS and serves as the lead GCS spokesperson at clinical and development related meetings. Working independently, the Program CSPM designs strategic and operational plans for all clinical supply activities associated with the clinical studies in their assigned compound(s)/ program(s). The incumbent is expected to have an understanding of the concepts of drug development, clinical research, and/or clinical supply chain, as well as interpersonal skills with a demonstrated ability to negotiate with key stakeholder groups and drive/influence results in a dynamic environment.

Primary activities include, but are not limited to:

• Interacts closely with key partner organizations (as a lead GCS Planning program representative) such as clinical development, regulatory, quality and other supply chain areas to negotiate timelines, strategies and other related topics for all clinical supplies across all assigned program(s).

• Responsible and accountable for establishing the timelines for bulk manufacturing needs and release of drug product across assigned program(s).

• Works directly in the SAP system to establish a consolidated, visible forecast for all products used within the assigned program(s) (i.e. Bulk Drug Product).

• Oversees all bulk drug supply management and ensures proper allocation of drug product as needed across studies within assigned program(s).

• Responsible for identifying significant supply risks associated with clinical bulk activities in addition to serving in a lead role for clinical supply issue escalation within their program(s) (and subsequent manage thereof) to GCS Leadership.

• Responsible for the clinical supply budget for respective program(s) and for supporting all protocol and program cost estimates requested by Product Development Teams.

• Responsible for authoring clinical supply documentation in support of labeling and packaging activities as well as supply chain documentation to support critical CMC activities.

• Support the collection of clinical supply chain metrics and/or participate in critical non-pipeline activities as a subject matter expert in a particular area of expertise.

• Mentors new team members and supports staff development, as needed.

Minimum education required:

Bachelor's degree in a scientific, business, or related discipline required, MS/MBA preferred.

Required Experience and Skills:

• At least 6 years of experience in project management.

• At least 3 years of experience in planning, scheduling, coordination and processing of supply chain activities, or the equivalent.

• Understanding of the concepts of material requirements planning (MRP) systems and demand planning principles

• Strong organizational, time management and problem solving skills.

• Results oriented with the proven ability to execute on collaborative projects and develop subject matter expertise.

• Exceptional written and verbal communication and relationship skills along with high personal integrity, credibility, and energy.

• Ability to prioritize tasks and initiatives appropriately to mitigate supply risks.

• Advanced proficiency in Microsoft Excel, PowerPoint, and Word.

• Experience with change management and leading process improvement initiatives.

Preferred Experience and Skills:

• Demonstrates ability to negotiate, resolve conflicts and engage in decision making as well as partner and influence across functional areas and organizations.

• Strong knowledge of the principles of project management and clinical customer relationship management.

• Strong knowledge of drug development, production, distribution, shipping, destruction, and reconciliation processes and procedures.

• Knowledge of order management, supply chain operations and document control.

• Experience leading teams

• Familiarity with data analytics/visualization software.

#VETJOBS

GCSCareer

#EligibleforERP

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.

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

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.

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

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:

$135,500.00 - $213,400.00

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:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a