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Sr. Manager, Clinical Supply Management (SF or Remote)

Employer
Nektar Therapeutics
Location
San Francisco, CA
Start date
Nov 16, 2021

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Discipline
Clinical, Clinical Research
Required Education
Bachelors Degree
Position Type
Contract
Hotbed
Biotech Bay, Best Places to Work

Job Details

The Sr Manager, Clinical Supply is responsible for managing varied levels of the Nektar clinical supply chain, as described in detail, below.  This role will initially be focused on Operations-related activities (Production, Logistics, and Inventory Management), but may evolve to include upstream work, such as clinical study set-up, demand planning, budget management, etc.  The successful candidate must have broad experience working in a GMP supply chain and be able to adapt to flexible requirements within the responsibilities defined below. Assigned tasks are performed on time, within budget, and with good quality, in compliance with regulatory requirements and Nektar's SOPs. This role applies to internally-sourced and/or CRO/Partnered studies. Collaborates cross-functionally with varied internal and external partners.  Effectively meets the customer expectations in the delivery of CSM to support the key Nektar clinical milestones for study starts and patient resupply. 

Responsibilities:
•    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. 
•    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 through receipt by the clinical site.
•    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 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.
•    Develop and implement process initiatives in accordance with business needs. Assist / author / implement SOPs.
•    Develop, monitor, and report metrics and KPIs.  Highlight positive and negative trends, and lead periodic KPI review sessions with internal and external partners.
•    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.
•    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.
•    Supply Planning:  An advanced understanding of supply planning and inventory coverage is preferred for this role, but supply planning is not currently a part of job requirements.  
•    Provides input to the development of IP-related study documents including protocols, study and pharmacy manuals; Oversees setup and management of IVRS (IWRS) Inventory tracking.

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.


 

Company

Nektar Therapeutics is a research-based development stage biopharmaceutical company that discovers and develops innovative medicines in areas of high unmet medical need. Our R&D pipeline of new investigational drugs includes treatments for cancer and auto-immune disease. We leverage Nektar's proprietary and proven chemistry platform in the discovery and design of our new drug candidates. Our success is rooted in four key elements: our track record reflected by a portfolio of successful approved medicines which emanated from our chemistry platform and are made available globally by our pharmaceutical partners, our unique research and development pipeline of new investigational medicines in cancer and immunology, our proprietary and proven science and technology approach that fuels our discovery efforts and our team of dedicated scientists, clinicians and employees focused on bringing new medicines to patients with debilitating diseases.

Stock Symbol: NKTR

Stock Exchange: NASDAQ

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Company info
Website
Phone
415-482-5300
Location
455 Mission Bay Blvd South
San Francisco
California
94158
United States

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