Sr. Manager, Clinical Supply

Location
San Francisco, CA, United States
Posted
May 04, 2018
Ref
3161-370-R
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Position Summary:

The Sr. Manager, Clinical Supply is responsible for forecasting Investigational Product (IP) supply requirements for multiple clinical trials and for managing the IP distribution process to one or more clinical trials. Activities are performed on time, within budget, and with good quality, in compliance with Regulatory Authorities' regulations/guidelines and Nektar's SOPs. Contributes to ongoing process improvement initiatives. This role applies to internally sourced studies and/or CRO/Partnered studies. Collaborates and interacts with Clinical Trial Managers, therapeutic area Project Managers, Medical Monitors, as well as staff from Quality, Clinical Compliance, Regulatory, Formulations, CMC, External Manufacturing, and Stability. Effectively meets the customer expectations in the delivery of CSM to support the key Nektar clinical milestones for study starts and patient resupply. Erroneous decisions will result in critical delays in schedules and/or unit operations and may jeopardize overall business activities.

Responsibilities:

Supply Planning

• Serves as lead logistics manager for the functional area in supply planning, including demand forecasting. Manages supply planning and timelines to ensure alignment with study plans and timelines and overall clinical development plan; Works with CSM management to determine resourcing needs; Provides input to the development of IP-related study documents including protocols, study and pharmacy manuals; Responsible for working within established timelines of investigational product manufacturing, labeling, release, distribution and return/destruction, and/or helping to establish these timelines; Oversees setup and management of IVRS (IWRS)

Inventory tracking

• Manages and tracks investigational product (IP) inventory; advises supply management team of potential shortages and makes recommendations for resupply activities based on usage trends by performing routine forecasting / demand planning.

Shipments

• Oversees IP shipment orders according to supply plans to ensure timely and compliant shipment and delivery to investigator sites from order request thru acknowledgement of receipt by the clinical site.

IVRS

• Working knowledge and experience with Interactive Response Technologies (IRT); Work with cross-functional teams to develop specifications and user testing of IRT systems provided by 3rd party vendors. Lead effort for clinical supply management functionality; Monitor and manage clinical supply activities through IRT from study start-up through study closure; Ensure appropriate system documentation is transferred to Nektar for TMF and inspection readiness.

Temperature excursions

• Reviews and evaluates temperature excursion data by following relevant SOP; provides assessments to supply management team regarding excursion trends in each study.

Returns & Destruction

• Reviews drug return and destruction records; communicates with investigator sites, CROs and external vendors to resolve issues.

• Performs 100% drug accountability from bulk drug, production, distribution, and returns / destruction.

• Authorizes final destruction of drug returns to 3rd party vendor.

Expiry Management

• Monitors IP expiry data and informs CSM and CMC teams of pending IP expiry needs.

Ancillary Supplies

• Develop plans for supplying clinical study sites with ancillary supplies, either through in-house initiated supply or working with supply vendors.

Documentation

• Ensures appropriate documentation of IP supply activities is provided for the Trial Master File. Reviews IVRS specs and reviews IVRS user manuals; Designs, reviews and approves IP-related labels and study tools (for clinical study teams and investigative site use), as needed. Supports inspection team in preparation for and during regulatory agency inspection.

Study Team Interaction

• Represents CSM on cross-functional study team (s) and/or sub-team(s); Provides input into budgets, SoWs, contracts and timelines for IP-related services; Prepares or provides input into IP-related content for training materials and coordinates training on study procedures; In collaboration with the CTM for study, provides input into IP-related study specific working practices; Establishes study team contacts, roles, responsibilities, and objectives for IP-related services; Develops, manages, and maintains relationships with external partners; Effectively communicates with CROs, shipping and IVRS vendors, study sites and study team members to ensure ongoing successful execution; Acts as point of escalation for IP-related issues.

Vendor Management

• Leads management of IP service vendors (performance, quality, timelines, deliverables, costs); Participates in preparation of RFP, assumptions and SOW for CROs and IP services vendors (labeling, packaging, distribution; IVRS/IWRS); Provides input, reviews, and approves vendor study specifications; Serves as point of escalation for vendor-related IP issues as they arise; Reviews and approves/scrutinizes specified costs on vendor invoices against contract, as delegated; Recommends vendors to CSM and Clinical Study Teams.

Does not supervise staff. May mentor or coach junior CSM staff.

Process Initiatives

• Develop and implement process initiatives in accordance with business needs.

• Assist / author / implement SOPs.

Requirements:

Bachelor's degree and at least 10 years of relevant experience in the biotechnology/pharmaceutical industry, with 3 years minimum in clinical supply management. Experience developing trial drug supply plans; Investigational Product forecasting skills; Working knowledge of the clinical drug development process and clinical trial methodology; Knowledge of ICH/GCP and regulatory guidelines/directives; Leadership and negotiation skills; Ability to effectively multi-task and prioritize; Effective problem solving skills; Written and verbal communication and presentation skills; Project management and organizational skills; Computer skills, with competency in MS Word, Excel; Study Tools including electronic system skills IRT; Interpersonal skills; Cross functional and cross-cultural awareness; Ability to work in a matrix environment. Frequently interacts with subordinate supervisors, customers, and/or functional peer group managers. Often must lead cooperative efforts among members of a project team.

We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.