Product Development Leader
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POST DATE 9/17/2016
END DATE 10/18/2016
San Diego, CA
JOB DESCRIPTIONAPPLY POSITION SUMMARY
The Product Development Leader (PDL) oversees the product development programs for the company's biosimilar products. Partnering closely with Manufacturing, Clinical Development, Commercial, Project Management, Regulatory Affairs and Corporate functions, the PDL formulates and executes the product development plan, including but not limited to leadership, budgeting, communication of assigned product's statuses, process development, monitoring, tracking, analytical, clinical, manufacturing, legal, commercial and regulatory affairs activities.
ESSENTIAL DUTIES AND PRIMARY RESPONSIBILITIES
Leads product development teams, consisting of cross-functional team members, to formulate, revise, and execute the product development plan and budget starting from target selection through BLA/NDA approval
Represents the Product Development Team at internal management/portfolio reviews, regulatory agency meetings, KOL interactions, and external scientific/business conferences and partnering discussions as appropriate
Acts as the project champion for assigned products to include driving and facilitating project meetings; helps to manage and mentor team members
With support from project management, establishes the product development plan, progress tracking documents, and work/resource allocation plans
Manages external relationships and resources to ensure the timely delivery of quality support of product development (e.g. CMOs/CROs, consultants, temporaries, vendors)
Oversees and participates in the identification and selection of 3rd party service providers, including drafting of proposal requests, scopes of work and contractual agreements for development, consulting, manufacturing, analytical, regulatory and clinical services
Partners with finance to document project-related invoicing to include the completion of contractual work for auditing purposes; tracks and manages projects to budget
Ensures that policies and procedures are followed in accordance with federal, state and company/department processes, protocols and regulations
Makes recommendations to improve processes and procedures on an ongoing basis (continual improvement) and executes or drives changes as required
Other duties as assigned or required