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Clinical Supply Project Manager


Lake Forest H3, IL
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Job Details

Job Title Clinical Supply Project Manager

JobID 1607534

Location: Lake Forest H3, IL

Description **ROLE SUMMARY**

The Clinical Supply Project Manager (CSPM) is responsible for leading the development and

execution of investigational material supply strategies for early and late stage development

programs intended for regulatory approvals of new products and for new indications or

line extensions of currently approved products within the Pfizer Essential Health (PEH) business.

The CSPM is responsible for designing the appropriate clinical supply strategy, managing

the clinical supply risks and costs in alignment with the clinical protocol, the budget and

regulatory environment. Works as a key member of the PharmSci Project Team, proactively

recognizes and addresses logistical and regulatory issues associated with the requirements of the clinical development program and project team objectives. Acts as a subject matter expert on all information regarding the global use of investigational material in clinical studies. Accountable for PEH clinical supply delivery and oversight of end-to-end process from active pharmaceutical ingredients/drug substance through planning to finished product received at the clinical sites and to the patient. Effectively manages Clinical Supply Teams and a network of internal and external partners in order to ensure PharmSci meets the customer expectations and supports the key Pfizer Clinical milestones for study starts and patient resupply.

The CSPM may be responsible for interfacing with external academic research organizations,

clinical research organizations and other pharma companies. These interactions also include

development of contractual agreements involving quality, legal and division leadership



+ Translate early and late stage development product strategies into effective PEH clinical supply strategies. Clinical supply strategy is reflected in operating plans, inclusive of scope, time, cost, risk and communication plans.

+ •Participate as a key team member representing GCSC on Core PharmSci and Study teams.

+ Support compassionate use patients when required.

+ Manage clinical supply delivery timelines to maintain alignment with portfolio milestones.

+ Through a solid understanding of clinical study design and drug supply risks, the CSPM must develop supply strategies that balance cost and risk.

+ The CSPM influences the team to adopt strategies that are right for the business through demonstration of solid drug supply knowledge.

+ Provide innovative solutions to clinical drug supply production and distribution.

+ Create and implement these solutions through utilization of vendor resources for all aspects of supply.

+ Leverage the knowledge and skill of in-house vendor points of contact to drive successful execution of unit operations


B.S. degree within a scientific discipline required with 2-5 years pharmaceutical industry

experience and 1-3 years clinical supply chain management experience.

• Training in supply chain management, a scientific discipline, or business

administration is desirable.

• Strong background in cGMP, cGDP, and ICH requirements.

• Demonstrated skills in project management and working with vendors.

• Demonstrates an ability to work independently with programs requiring moderately complex

support. Able to formulate options with guidance from management.

• Strong focus on customer service and demonstrated ability to communicate.

• Solid knowledge of drug development process.

• Solid understanding of clinical study design including tele randomization, pharmaceutical


• Management of multi-disciplinary teams that includes measuring work, negotiation, conflict

management, process improvement, project management.

• Possesses a good foundation in making decisions within a cross functional team, and

effectively develops, communicates, and gains support for execution plans with a wide range of stakeholders

• Experience managing change in a dynamic, complex environment.

• Experience with sourcing, contract manufacturing/packaging, distribution, supplier

management and supply chain management is highly desirable.


Ability to work in a fast paced and dynamic environment that will require management of

several competing priorities while driving all projects forward and meeting program/project




**EEO & Employment Eligibility**

**Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.**

**Sunshine Act**

**Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.**

+ **Last Date to Apply for Job: Sept 1, 2017**

+ **Grade: Hospira grade 17**

**A career at Pfizer offers opportunity, ownership and impact.**

**All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the bio-pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.**

**Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.**

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