• Sr. Counsel

    Job Locations US-CA-Seal Beach
    Job ID
    2018-1262
    Category
    Legal
  • Overview

    The Sr. Counsel provides assistance to the SVP, General Counsel in a broad range of legal department responsibilities including, but not limited to commercial and other contracts, employment, CMC and manufacturing, compliance, privacy, regulatory, intellectual property and internal and public communications. Responsible for providing clear legal advice and practical results-oriented, business-focused solutions enabling the business to achieve its objectives while preserving and protecting the company's integrity and reputation. The successful candidate will have significant depth of experience working for public or private companies, preferably in the biotechnology and/or biopharmaceutical industries.

    Responsibilities

    • Works closely with key stakeholders in the organization to review key business strategies and provide legal advice to multiple functions, including technical operations, commercial operations, medical and clinical affairs, IT, research and development, supply operations, HR and facilities
    • Drafts and negotiates a wide range of legal documents typical of a biotech or pharmaceutical organization, including master service agreements, supply agreements, materials transfer agreements, clinical trial agreements, license agreements, manufacturing agreements, confidentiality agreements, research collaborations with academic institutions, agreements with governmental entities, vendor agreements and other general business contracts.
    • Advises internal clients on contract interpretation, dispute resolution and other legal risks associated with all aspects of the company’s business.
    • Assist with the development of company policies and procedures, and standard template language to be used in contracts.
    • Advises internal clients on product supply chain, including manufacture, distribution, reimbursement and price reporting.
    • Participates in the selection and management of external legal counsel including cost effectiveness.
    • Conducts due diligence evaluations for possible business transactions.
    • Monitors regulatory and clinical activities for legal compliance.
    • Ensures coordination with internal legal department and non-legal departments and directs the escalation of issues driving them to resolution.
    • Develop and continually expands a thorough understanding of Dendreon's current and planned business activities, programs, competitors, and markets and keeps abreast of developing legal trends, laws and regulations.
    • Provide support for company litigation as needed.
    • Research unique legal issues impacting the organization and its business by identifying applicable statutes, judicial decisions, and codes.
    • Provide training to company and its affiliates on substantive legal topics.
    • Other duties as assigned
    • This position is based in Seal Beach, CA and will report directly to the Sr. Vice President, Legal and Compliance and General Counsel.

    Qualifications

    • JD degree and requisite active bar licensure, preferably in CA
    • Minimum 8 of years of relevant experience required with at least 5 years as in-house counsel at a public or private company.
    • In-house counsel experience in the field of biotechnology/pharmaceutical research and development and its related FDA regulations is preferred.
    • Ability to understand and negotiate details and nuances of contract language.
    • Broad knowledge of the legal and regulatory framework for the development, manufacture, distribution and commercialization of pharmaceutical products.
    • Experience representing public and private companies.
    • Highly developed ability to write memos, correspondence, and procedures on legal matters and to communicate effectively, both orally and in writing, with lawyers, management, and business partners.
    • Solid negotiating skills with excellent analytical abilities and sound judgment.
    • Multi-tasking abilities necessary to ensure all aspects of legal work are pro-actively completed in a timely manner.
    • Ability to work independently.
    • Skilled at clearly conveying in-depth knowledge to all levels within, and outside of, the organization.
    • Skilled at creating a cooperative team environment.
    • Able to objectively evaluate situations and make recommendations for changes in light of overall project demands.
    • Enthusiasm to work on a broad variety of legal matters and ability to manage and serve a wide range of clients within the company by recognizing and responding quickly and pragmatically to urgent situations and demanding clients.
    • Ability to form strong working relationships with partners and employees while maintaining firm adherence to proper legal standards
    • Ability to work independently, to prioritize to meet tight deadlines and adjust to workload fluctuations
    • Excellent business judgment and strategic thinking
    • Strong negotiation and drafting skills, communication, administrative, and time management skills
    • Accountability and integrity

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