TITLE: Associate Director, Clinical Supply Chain Management

REPORTING TO: Chief Scientific Officer, Center for Biomedical Research, Population Council

LOCATION: Center for Biomedical Research, New York, NY OR Remote

JOBS SUPERVISED: N/A

ASSIGNMENT LENGTH: Indefinite

POSITION SUMMARY: The Population Council conducts research to address critical health and development issues. Our work allows couples to plan their families and chart their futures. We conduct research and programs in more than 50 countries. Our New York headquarters supports a global network of offices in Africa, Asia, Latin America, and the Middle East. 

Through its Center for Biomedical Research (CBR), the Council has developed and licensed some of the most widely used long-acting, reversible contraceptives in the world. We are seeking an Associate Director, Clinical Supply Chain Management to play a key role in managing all aspects of clinical supplies, including but not limited to, clinical trial forecasting, clinical trial material labeling and distribution strategies, clinical trial vendor management, clinical trial contract/budget negotiations, and sampling inventory and distribution. The individual will also be responsible for managing commercial supplies including but not limited to manufacturing support, order fulfillment and logistics. 

RESPONSIBILITIES: 

1. Forecasting and Projections

· Create, track, and analyze the rolling clinical product demand forecast.

· Troubleshoot and communicate problems to key stakeholder departments.

· Collaborate on the manufacturing schedule to ensure uninterrupted supplies from manufacturing to research centers for clinical trials and in support of drug product for commercial use.

2. Commercial Products

· Collaborate with CMO and internal departments to support manufacturing and commercial supply chain activities.

3. Clinical Trial Supplies

· Provide on time, appropriately packaged, and labeled clinical trial material and ancillary supplies for the Council and contractual partnerships.

· Collaborate with Clinical Operations or research center to ensure inventory levels are continuously adequate.

· Collaborate with Clinical Operations regarding Study Operations Manual sections for clinical trial material distribution, storage, and maintenance.

· Facilitate global distribution of clinical trial material to research centers.

· Source and evaluate vendors for clinical trial material packaging, labeling and distribution.

· Assist in the development and audit of the clinical IVRS/IWRS (Interactive Voice/Web Response System) and serve as administrator of the system

· Request, review, and approve technical specifications, work orders and/or contracts for clinical supplies.

· Act as unblinded role for blinded clinical trials to investigate discrepant or questionable data.

4. Inventory Management, Sampling, and Distribution

· Maintain contractual agreements with vendors relating to cGMP and non-cGMP bulk materials.

· Facilitate bulk inventory sampling and shipping and communicate progress to shipment requestor.

· Maintain inventories of bulk material.

· Manage logistics of distribution of commercial supply from manufacturer to commercial buyer/distributor.

5. Vendors

· Evaluate vendors for performance and quality.

· Create and maintain contracts, work orders, and budgets.

· Evaluate and approve invoices for correct dollar values, project codes, and budget line items.

6. Miscellaneous

· Review and update or create new SOPs as needed.

· Other duties as assigned.

QUALIFICATIONS: 

We recognize that strong candidates may not have every qualification listed here, and encourage applications from individuals who bring passion, skills, and experience in many or most of these areas.

1. Bachelor’s degree in Life Science or related area, Master’s degree strongly preferred.
2. Minimum of 8 to 10-years-experience in oversight of packaging, labeling, and global distribution of clinical trial supplies.
3. Supply chain management experience or training.
4. Thorough understanding of cGMP and cGCP.
5. Strong knowledge of production planning and timeline management.
6. Strong knowledge of inventory sampling, receiving, and shipment. Including international shipping requirements.
7. Must be capable of collaborating with various levels of internal and external personnel including suppliers, CMOs and distributors.
8. Must be detail-oriented, proactive, and flexible.
9. Excellent verbal and written communication skills.
10. Build and maintain professional interpersonal collaborative relationships.
11. Accomplish goals under pressure.
12. Manage timelines and communicate internally or externally as appropriate.
13. Strategic and creative problem-solving skills.

SALARY AND BENEFITS: Salary range between $110,000-$151,000 annually, depending on knowledge, skills, and experience. Excellent benefits package includes medical, dental, vision and life insurance available immediately upon hire; 403(b) retirement plan with employer contribution equal to 12% of annual salary after one year of employment; generous annual and sick leave; and paid parental leave. We strive to provide an environment of professional growth and development. 

Application Deadline: June 15, 2022

When applying through the web portal please attach your CV and Cover Letter in Word or PDF format.

The Council requires all U.S. based staff, interns and fellows to be fully vaccinated against COVID-19. New staff members must verify vaccination at the time of hire. Exemptions will only be considered for medical reasons and sincerely held religious beliefs. Exemptions are not guaranteed and must be discussed with Human Resources. 

The Population Council is an international, nonprofit, nongovernmental institution that seeks to improve the well-being and reproductive health of current and future generations around the world and to help achieve a humane, equitable, and sustainable balance between people and resources. The Council conducts biomedical, social science, and public health research and helps build research capacities in developing countries. Established in 1952, the Council is governed by an international board of trustees. Its New York headquarters supports a global network of country offices. We are seeking an individual to fill the position described. If you know of a qualified candidate or are interested in this position, please apply at: http://www.popcouncil.org/employment/index.asp.

The Population Council provides equal opportunity; it does not discriminate against any person with regard to age, color, creed, national origin, disability, political belief, veteran status, religion, marital status, gender, gender identity, or sexual orientation. Decisions on employment are based on an individual’s qualifications as related to the position for which they are being considered. The Council especially encourages applications from members of underrepresented groups including but not limited to Black people and people of African descent, Indigenous people, people of color, women, LGBTQ+ individuals, including people who identify as transgender, non-binary, or gender expansive, people with disabilities, first-generation college graduates, and those from communities with the most to gain from expanded access to sexual and reproductive health services and information. The Population Council is international in the composition of its board of trustees and its staff, as well as in the nature and deployment of its activities.