Comparator Strategist (Sr Manager)

Org Marketing Statement

All over the world, Pfizer colleagues are working together to positively impact health for everyone, everywhere. Each position at Pfizer touches and contributes to the success of our business and our world. That's why, as one of the global leaders in the biopharmaceutical industry, Pfizer is committed to seeking out inspired new talent who share our core values and mission of making the world a healthier place.

Role Description

* Pharm Sci Global Clinical Supply Chain key point of contact for defining strategy related to Open label commercial material requirements. Strategy development t can include comparative agent acquisition from multiple avenues including Local Sourcing, Centralized Sourcing, and site purchasing.

* Work with SCLs and Project teams to ensure that the Open label commercial strategy required in the protocol is met.

* Work with Comparator Agent Sourcing Specialist in Drug Product Supply (DPS) to ensure timely supply and appropriate sourcing where required

* Through a solid understanding of clinical study design and drug supply risks, the CS must develop comparator supply strategies that balance cost and risk. The CS influences the clinical team to adopt strategies that are right for the business through demonstration of extensive comparative agent drug supply knowledge and protocol design.

* Provide innovative solutions to comparator drug supply acquisition and distribution. Create and implement these solutions by utilizing the knowledge and skill of in-house vendor points of contact to drive successful execution of unit operations.

* Work directly with partner lines and Pharm Sci Vendors for Local Sourcing, budget management, operational timelines, regulatory and technical queries.

* Participates in the Clinical Supply Team as needed to assess comparator needs and present options for central, local and sites sourcing as required per protocol

* Collaborate with Clinical Pharmacy group to reinforce the alignment toward our Patient focus strategy and delivery of Supplies, gather information about clinical site sourcing options (pharmacy, Standard of care available in the country, pharmacy card) and develop knowledge of diseases requiring comparator (Oncology. Biosimilars...)

* Collaborate with GCS Regional Operations and Local Sourcing Vendors to consult on label requirements and drug availability in the countries/regions.

Responsibilities

Responsible for establishing comparator material supply strategies for early and late stage clinical development programs intended for regulatory approvals of new products and for new indications or line extensions of currently approved products.

* I includes evaluating the pros and cons of locally sourced materials, Pharmacy-cards,

re-imbursement, central sourcing and regional sourcing.

* This includes sourcing of Pfizer commercial drugs locally to supply Clinical studies as required.

Working as a key member of the Clinical Supply Team, proactively recognize and address logistical and regulatory issues associated with the requirements of the clinical development program and project team objectives.

Accountability for planning and forecasting of the comparator needs based on the draft and final protocol, review with Pharm. Sciences Local Sourcing Vendors and Regulatory availability for each product in each country.

Utilize the Clementine planning tool to provide forecasts to internal and external stakeholders of comparator supplies.

Coordinate regulatory reviews and confirm requirements for labels needs with Pharm.

Sciences Local Sourcing Vendors and Regulatory.

Collaborate with DPS team to develop any blinded product

Accountability for comparator supplies delivery and oversight of end-to-end process from sourcing to finished product received at the country depots or clinical sites.

Work with Comparator Agent Sourcing Specialist and the Comparator Vendors to ensure timely delivery of supplies

Follow appropriate guidance and SOP's regarding non-Pfizer commercial product sourcing activities.

* Simultaneously define strategy for multiple projects to meet the needs of the global clinical teams

* Provide internal customers and support groups with real time project status reports.

* Track the fiscal spending and provide reports to show how the budget has been managed

Work across GCS, GCMC, WRS and DPS to provide information for development of comparator sourcing strategies. This may include providing cost information and identification of potential sourcing challenges with comparator products and the proposal of options to support both immediate and long term needs.

Work with Procurement and Finance as needed to resolve issues regarding purchase of comparative agents. Ensure POs are routed through appropriate channels and work with SCL, Clinical Team and Asset Leads to get budget approval for each PO. Work with Dev Ops and APs to provide oversight of site and depot inventory for supplies locally sourced and review with Clinical Team and SCL needs for re-supplies.

Qualifications

Training & Education:

B.S. degree (or equivalent) is required.

Advanced training in supply chain management, a scientific discipline, pharmacy, Development Operations, Clinical sites, Comparative Agents and/or business administration are desirable.

Prior Experience:

Drug development, clinical study design including tele-randomization, scientific research, pharmaceutical manufacturing/packaging/labeling.

Background or experience in Clinical Sites Operations and clinical trials execution, medical or drug market knowledge for oncology would be advantageous

Project Management certification is desirable

Management of multi-disciplinary teams that includes measuring work, negotiation, conflict management, process improvement,.

Experience with sourcing, vendor management, contract manufacturing/packaging, distribution, supplier management and supply chain management are highly desirable.

Proven ability to effectively develop, communicate, and gain support for execution plans with a wide range of stakeholders

Customer oriented, ability to work with SCL and the Clinical Team to influence strategic decision that will saving $ to Pfizer Inc.

Ability to manage large budget and associated financial aspect to deliver on time against tight timelines

Experience managing change in a dynamic, complex environment

Demonstrated interest in Patient Quality and Compliance.

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.