Senior Director, Legal Counsel

SUMMARY

Reporting to the Chief Compliance Officer, responsible for managing legal matters affecting the Company including: (i) having primary responsibility for the Company’s contracting process, (ii) providing a variety of general corporate and commercial legal advice and services directly or through liaison with outside counsel, (iii) coordinating legal matters handled by outside counsel, (iv) assisting in the development and oversight of the Company’s compliance programs, and (v) anticipating and guarding against legal risks facing the Company.

Specifically, Senior Director, Legal Counsel will:

  • Oversee the Company’s contract review and approval policy.
  • Draft, negotiate and review clinical trial-related agreements to support multiple worldwide clinical programs.
  • Draft, negotiate and review a wide variety of other agreements including non-disclosure agreements, consulting agreements, manufacturing agreements, service agreements, material transfer agreements, licensing agreements, collaboration agreements, quality and technical agreements and work orders.
  • Develop standard form agreements and implement processes for and training of internal clients on contract forms and procedures.
  • Provide counsel and legal support to various departments including, but not limited to, Medical Operations & Clinical Operations, Non-Clinical Development, Supply Chain/CMC, Regulatory, and Business and Commercial Operations.
  • Review and provide guidance on compliance with corporate policies, including oversight of LMS/Compliance training.
  • Ensure Transparency (Sunshine Act) reporting is properly reported on behalf of the company, and the organization is complying with various requirements related to the Act.
  • Manage relationship with outside counsel on certain matters and coordinate any service provided by them.
  • Assist in intellectual property, securities and general corporate matters, as needed.
  • Other responsibilities, as necessary.

TRAVEL REQUIREMENTS

Minimal domestic travel.

EDUCATION & EXPERIENCE

Technical Skills/Knowledge

  • 10 years of general corporate legal experience as an attorney in a law firm, corporation or both.
  • Experience in the pharmaceutical or biotechnology industry, preferably in an in-house capacity.
  • Extensive experience drafting, reviewing and negotiating commercial contracts for a pharmaceutical company.
  • Experience with general corporate law issues and FDA regulations related to promotion of pharmaceutical products and emphasis on doing business in and understanding the regulatory environment (including FDA, OIG, SEC, and NASDAQ).
  • Ability to handle diverse legal matters using external expertise as required.

Independence/Accountability

  • Must be a self-starter, resourceful and able to participate in a highly collaborative, team-oriented environment.
  • Must be able to handle, prioritize and follow through on a high volume of work, including the ability to anticipate and manage changing priorities and timelines.
  • Must have a strong commitment to corporate compliance.

Problem solving

  • Has the ability to work on complex problems in which analysis of situations requires an in-depth evaluation of various factors.
  • Suggests and implements solutions to problems.

Leadership Activities

  • Expected to assist others with problem solving.
  • Proposes ideas and presents data within own group.
  • Participates in interdisciplinary team meetings.
  • Is accessible to others for technical advice.

Communication Skills

  • Excellent communication skills, both oral and written.
  • Must work well with others.
  • Actively participates in own team meetings.
  • Assists other departments as necessary.

Customary Education and Experience

  • D. from accredited law school.
  • Must be licensed to practice law in Pennsylvania.

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Accepted formats: PDF, Word Doc

Accepted formats: PDF, Word Doc