AVP, Global Clinical Supply

Job Description

The Associate Vice President (AVP) is responsible for providing leadership for the Global Clinical Supply (GCS) group within Pharmaceutical Sciences & Clinical Supply (PSCS) which encompasses planning, packaging, labeling and distribution of clinical supplies with associated support functionality.

The GCS organization is committed to supporting an on time, accurate, compliant clinical supply chain, providing supplies to the right place, at the right time. The ideal candidate should be a visionary leader with passion for operational excellence, as well as an established track record in leading clinical supply organizations and continuous improvement of processes/ systems. The successful candidate will partner with key stakeholders in drug product development, pilot plant clinical supply manufacturing, quality, clinical operations and clinical program leadership to achieve the goal of a consistent, compliant clinical supply chain to support a large global footprint of clinical studies. A strong track record to anticipate and solve diverse and significant challenges across the clinical supply chain is required as well as experience in utilization of a combination of internal and external, as well as contract staff, to flexibly achieve desired business goals. The incumbent will need to have strong strategic and leadership skills to manage and solve problems for the diverse and fluid requirements of our complex clinical supply chain. 

The key immediate needs and opportunities for the role include:

• Exquisite stakeholder management and partnering skills that ensure mutually agreed upon success measures and foster high trust relationships

• Build talent, develop expertise, strengthen leadership influence, all while fostering a culture of inclusion and innovation

• Clarifying and ensuring clear lines of accountability for the requisite work functions within GCS remit

• Proactively identifying risks and implementing mitigations to enable strong operational performance leveraging data informed decision making

• Business process continuous improvement that allows for enhanced efficiency in standard workflows with required responsiveness/flexibility to project-specific needs

The AVP should demonstrate effectiveness in the following key dimensions and responsibilities:

• Fluent in all aspects of CMC development to effectively integrate and partner with various upstream stakeholders

• Good understanding of the impact of clinical supplies dynamics and how it impacts clinical trial execution across all modalities and therapeutic areas

• Strong stakeholder management, communication skills and results-orientation

• Motivating and inspiring leadership that creates high expectation for excellence within the team, fostering a culture of learning and continuous improvement 

• Focused on attracting, coaching, and building talent at all levels in the organization and supporting diverse talent

• Creates a positive work culture that is both inclusive and allows for growth/personal fulfillment

• Experience in managing budget for headcount, internal/external supply chain providers and comparator supply

• Continuously optimize physical assets, resources, and supply inventory across the entire supply chain

• Strong knowledge of regulatory and quality aspects of clinical supply chain with a track record demonstrating a high commitment to compliance

• Provides strategic innovation leadership, originates, and develops new process improvement and change initiative ideas. Identifies process improvement opportunities, recommends pathways for solutions and drives idea generation, proposals and implementation

• Creative and proactive problem-solving skills, including ability to escalate issues in a clear, direct, and succinct manner

• Recognized as a strong subject matter expert in all aspects of clinical supply chain logistics, influences senior leaders in defining our company's strategy

• Recognized within broader external field as a leader in clinical supply chain and at the forefront of leadership in the discipline

• Champions innovation as a means to create competitive differentiation for our activities as well as the overall means by which clinical supply is delivered and utilized

• A track record of consistently delivering innovations and implementing novel approaches to impact across the pipeline.  Interest and experience to adopt and integrate digital solutions

Education:

• Ph.D. in relevant scientific or engineering discipline with 10+ years of product development and clinical supply experience or BS/MS with 15+ years of relevant education and experience

Required Experience and Skills:

• Import/export knowledge desirable

• Ability to communicate and maintain collaborative relationships effectively with key internal and external stakeholders

• Proven ability to select, secure and manage external vendors at a senior manager level to achieve results and control expenditures

• Demonstrated experience with global clinical supply forecasting, planning, packaging, labeling, inventory management, IVRS systems, clinical trial designs (randomized, double blind, placebo controlled)

• Thorough knowledge and understanding of cGMP, ICH/cGxP guidelines and global Health Authority requirements

• Good organizational, communication and presentation skills, effective project and time management skills and the ability to work under pressure

• Experience with regulatory submissions

• Experience with one or more aspects of CMC development, spanning from discovery to product filing

Location: Rahway, NJ or West Point, PA, with travel up to 25%. Successful applicant would be expected to interact across all Pharmaceutical Sciences & Clinical Supply (PSCS) and R&D locations

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:

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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, Monday - 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”.

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. 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 US 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.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

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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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