Corporate Counsel, Clinical Development

US-NJ-Jersey City
ID
2018-1078
# of Openings
1
Category
Legal

Overview

The Corporate Counsel, Clinical Development will provide legal services and support, primarily to Mitsubishi Tanabe Pharma Development America, Inc. (MTDA), Mitsubishi Tanabe Pharma Holdings America, Inc. (MTHA) and their affiliated companies. This is a dynamic role giving advice on legal and compliance issues as they arise from the clinical, safety, regulatory, medical, sourcing and executive teams of MTDA, and the business development, and research collaboration teams of MTHA.

Incumbent will be involved in all aspects of the development business and operate as part of cross-functional teams focused on developing pipeline products in the U.S. and acquiring or licensing products in the U.S. The attorney will be responsible for evaluating strategic and tactical research and development and business development plans, and advising clients on a broad array of issues relating to FDA pharmaceutical regulations, GxP requirements, product development, product labeling, non-promotional review, media materials, anti-trust, anti-kickback, competitor issues, compliance issues, regulatory policy, medical, industry and group company issues. The Corporate Counsel, Clinical Development will also be responsible for overseeing all contracts for MTDA and MTHA, including CRO agreements, clinical trial agreements, informed consent forms, consulting agreements, service agreements, supply agreements, and confidentiality agreements for MTDA, and development and license agreements, research collaboration agreements, terms sheets, consulting agreements, service agreements, and confidentiality agreements for MTHA.

Responsibilities

  • Provides strategic advice regarding research and development projects, business development matters, regulatory matters, compliance issues, contracts and interactions with respect to pipeline pharmaceuticals. Provides advice regarding research and development, business development, product sourcing and development, and competition practices.
  • Performs drafting and negotiation of contracts for the local business and advises management in connection with related matters.
  • Partners with legal department colleagues at MCHA in New York City and Jersey City in executing and enhancing Company and Legal Department objectives.
  • Supervises outside counsel as required.
  • Drives increased efficiency, coordination, and effectiveness of legal advice, processes, and support to meet the needs of the local business.
  • Emphasizes effective demand management, providing innovative solutions to meet client needs and address highest risks.
  • Works as part of a matrix leadership team at MTDA and MTHA (handling matters including clinical, regulatory, safety, medical, sourcing, finance, and HR).
  • Assists with supporting compliance function; helps create and deliver policies, procedures and training to MTDA and MTHA teams.
  • Leads by example and ensures consistent communication to MTDA and MTHA; is a beacon of compliance as a representative of the MCHA compliance program.

Qualifications

  • Juris Doctorate (J.D.) degree.
  • Admitted to the Bar of at least one state; and eligible for admission to the New York and New Jersey Bar (in-house counsel license acceptable).
  • Ideal candidates will possess a minimum of 4 years of experience handling transactions for a major law firm complemented by another 4 or more years of in-house experience with clinical development work.
  • Experience with FDA regulations and guidance provided by the Office of the Inspector General for HHS is required.
  • Excellent oral and written communication skills; strong presentation skills, with ability to communicate abstract ideas to executive and senior management.
  • Excellent critical thinking skills; ability to work through complex issues, including those with significant strategic risk to company.
  • Strategic, analytical thinker and creative problem solver who possesses innovation, client management skills, demand management skills and regulatory knowledge.
  • Selfless; promotes team and company objectives over individual accomplishments.
  • Strong organizational skills; proven ability to handle and prioritize high volume of work and independently manage multiple complex projects simultaneously.
  • Demonstrated broad understanding of business environment. Capable of anticipating future challenges resulting from change; ability to adapt quickly and keep up with a fast‐paced, highly demanding environment and regulatory framework.
  • Ability to respond resourcefully and strategically to shifting priorities and work effectively in ambiguous or challenging situations.
  • Energetic self‐starter with demonstrated influencing skills and results orientation. Ability to quickly gain trust and respect of senior executives, peers and clients.
  • Ability to work both in a strategic big picture mode, as well as tactically with ability to “roll up one’s sleeves” and work in detail.
  • Demonstrated client service orientation; ability to recognize and respond quickly and pragmatically to urgent situations and demanding clients while setting demand management and expectations for highest priority matters.
  • Flexible, and possessing a development, business focus.
  • Willingness to attend montlhly staff meetings in New York City.
  • Ability to sit or stand for long periods of time
  • Manual dexterity required to operate office equipment, i.e. computers, phones, copy machine/printer
  • Ability to carry, handle and reach for objects
  • Ability to lift and pull up to 15 pounds

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