Overview

Position Location: US-North Carolina  Research Triangle Park; US  Pennsylvania  Center Valley

Number of Direct Reports: 0

The Clinical Trial Division (CTD) of the Pharma Services Group, part of Thermo Fisher Scientific is focused on providing end to end clinical trial solutions for our customers. We dont specialize in any particular therapy  we support them all. Our customers range from small biotech/pharmaceutical start-ups to large pharmaceutical companies who focus on R&D and prefer to outsource supporting services for the execution of clinical trials across the globe. We have the industrys largest global footprint of FDA cGMP facilities and regional hubs strategically located around the globe so we can be where our customers need us  we provide the full suite of services in each of those hubs so that we can get the right medication to the right patient on time.

We strive to be one of the worlds most admired legal organizations within one of the worlds most admired businesses.

Position Summary:

The Associate Corporate Counsel, CTD (Clinical Trial Division) will assist CTD businesses in negotiating and drafting various agreements including: commercial, service, transportation, distribution, license, sourcing, supplier, quality, and consulting. In addition, the Associate Corporate Counsel will be responsible for (i) providing legal support to the Transportation businesses; (ii) advising CTD with regard to certain compliance and regulatory matters; (iii) interacting with outside counsel in certain aspects of CTDs business; (iv) and collaborating on certain legal projects and initiatives. Knowledge of the clinical trial industry is preferred.

Key Responsibilities:

  • Provide ongoing advice and support principally related to commercial, supplier and sourcing contracts, proposals, SOWs, etc. including the drafting, review, and negotiation of contracts
  • Provide guidance on a range of legal, regulatory and compliance matters, including, pharmaceutical clinical or commercial regulatory, transportation compliance, commercial antitrust, anti-bribery/FCPA, products liability, and data privacy
  • Provide legal support to the transportation businesses within CTD
  • Provide legal support to the comparator and clinical supplies businesses within CTD
  • Anticipate and drive solutions for a range of legal and business issues
  • Provide advice regarding customer and other commercial/business disputes
  • Monitor customer dispute processes
  • Monitor and administer contract review as well as other approval processes, policies, and contract playbooks
  • Collaborate on certain divisional projects and initiatives related to legal, compliance and/or regulatory matters

Minimum Requirements/Qualifications:

  • Bachelors degree required
  • Juris Doctorate required
  • Member in good standing with the state Bar
  • 8 years of business experience or equivalent combination of education, training and experience, with 3+ years including commercial law experience and managing commercial contracts and knowledge and experience working in pharmaceutical industry or similar contract manufacturing/supply chain solution provider
  • Ability to identify legal risks and develop strategic and tactical ways to minimize such risks
  • Must be able to evaluate fact patterns to advise on the application of the law (may require some oversight)
  • Ability to translate legal theory into applied business success
  • Experience in several of the following legal, regulatory and compliance areas: pharmaceutical clinical or commercial regulatory matters, transportation compliance, commercial antitrust, anti-bribery/FCPA, products liability, and data privacy
  • Proven negotiation abilities and business acumen
  • Customer centric and solutions-oriented approach in supporting both external and internal clients while protecting the best interest of the company
  • Experience managing contracts and providing support and guidance to legal professionals
  • Experience developing, driving and implementing legal solutions
  • Ability to deliver strong results with limited resources, under tight deadlines and with a high degree of accuracy
  • Strong oral and written communication skills
  • Ability to maintain strict confidentiality of sensitive information
  • Team player capable of participating within cross-functional project teams to meet key milestones under tight timelines and stressful conditions
  • Proven research and analytical skills
  • Understanding of commercial and financial implications of strategy development process
  • Strong project and process management capabilities
  • Strong organizational skills and attention to detail with proven ability to handle multiple tasks efficiently and effectively
  • Strong interpersonal skills and effective communication and presentation styles
  • Strong work ethic with ability to work independently
  • In-house experience with a CRO or pharmaceutical / medical device / biotech company preferred
  • Occasional Travel required

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