Head of Legal and Compliance, Europe

Head of Legal and Compliance, Europe

GBT - Global Blood Therapeutics

Zug, Switzerland

Position Summary:

This Zug-based position manages all aspects of the Legal function in Europe, providing general legal advice and support on legal matters, including governance, general corporate law, employment law, litigation and disputes, transactions, and the development, promotion and marketing of GBT’s products. In addition, he/she is responsible to develop and support a broad range of corporate and healthcare compliance activities in accordance with the Company’s Code of Conduct, other Company policies and procedures, and applicable laws and regulations in Europe.

The position reports to the Chief Legal Officer with a functional reporting relationship to the Senior Vice President, Head of Europe.

Essential Duties and Responsibilities:

  • Member of the GBT Legal and Healthcare Compliance (HCC) teams overseen by the Chief Legal Officer;
  • Member of the European Leadership team.

Legal including Corporate Compliance Support:

  • Provide ongoing strategic advice on laws, regulations and guidelines affecting product development/lifecycle, market access, and all brand matters (including advertising and promotional review);
  • Identify, advise on and minimize legal risks related to development, medical/scientific and commercialization activities for GBT’s therapies that are product candidates or are sold, marketed or distributed in Europe;
  • Ensure appropriate review of promotional, marketing and other company disclosure materials (branded and unbranded) to be disseminated in Europe;
  • Support the entity infrastructure in Zug (European headquarters) and the creation and maintenance of European legal entities and infrastructure elsewhere in Europe, including overseeing local counsel for corporate governance, corporate compliance, employment, contracting and related infrastructure matters;
  • In coordination with the Company headquarters Legal team, ensure the drafting, review, negotiation, execution and archiving of a wide variety of agreements, including drug distribution agreements, other commercial agreements and licenses in Europe, agreements for named patient programs and medical affairs activities, and other contracts covering all areas of business. Work closely with GBT Legal to ensure compliance with signature authority and other company contracts processes;
  • Advise on employment and labor law issues, in coordination with the Company’s HR partners and external counsel;
  • In coordination with the Company’s headquarters Legal team, manage corporate governance matters for Europe including compliance with corporate policies (e.g., insider trading, anti-bribery etc.) and corporate housekeeping;
  • In coordination with the Company’s headquarters Legal team, manage governmental investigations (including in relation to corporate compliance), product liability claims, product recalls and litigation affecting Europe;
  • Oversee obtaining and maintaining licenses and permits needed for European subsidiaries and serve as an interface with corporate regulatory and administrative bodies as needed;
  • Oversee and manage multiple outside counsel, including with regard to complex matters for the region and local in-country counsel.

Healthcare Compliance (HCC) Support:

  • Serve as an expert on EU healthcare compliance laws and regulations, liaise with outside legal counsel to monitor and assess state of compliance with European and country/local regulations; interpret and take necessary action as required by law;
  • Represent Europe’s needs/requirements with the HCC team and make sure that local requirements are communicated/included in the company’s policies;
  • Coordinate with the Company’s headquarters HCC team and lead in the construction, review and oversight of our first European HCC Program; includes leading in the construction of HCC policies and operational guidelines for all European affiliates;
  • Create and conduct in-person new hire, annual and topic-specific compliance trainings for sales force and general employees, in conjunction with the Company’s headquarters HCC team and external country counsels;
  • Provide HCC review of commercial and product related European legal agreements;
  • Build reporting capabilities for and manage European and country-specific transparency reporting obligations;
  • In coordination with the Company’s headquarter Chief Compliance Officer and Compliance Committee, lead, participate and assist in healthcare compliance-related audit, investigations, and monitoring in Europe; recommend and manage enforcement of disciplinary actions for compliance violations in Europe as necessary.

People:

  • Demonstrates organizational leadership and lives by GBT’s values;
  • Demonstrates the ability to attract talent and create a culture of collaboration and teamwork that foster open communication, constructive conflict and organizational flexibility;
  • Ensures alignment of responsibilities between solid and dotted line management;
  • Broad cultural orientation, ideally with experience working outside Switzerland in an international context.

Qualifications:

  • J.D. degree or equivalent. Qualified to practice as a member of a European Bar;
  • 10+ years’ legal experience in EU pharmaceutical industry with strong background in promotional and medical affairs rules and regulations as well as administrative law in major EU countries. Includes general contracts and corporate law, advertising and promotion of pharmaceutical law, data privacy, anticorruption, statues, aggregate spend reporting requirements and other corporate/healthcare compliance matters;
  • Fluency in English;
  • LL.M or advanced degree;
  • Experience/familiarity with US regulatory landscape a plus;
  • Track record of successfully operating in a matrix management environment;
  • Experience and exposure to legal and compliance for specialty pharmaceutical products;
  • Strong oral and written skills in major European languages;
  • Has the ability to create the strategy in a “green field” environment but can also prioritize operationally and execute independently and is a self-starter;
  • Interacts successfully by creating alignment horizontally and vertically with internal and external stakeholders and is able to influence and direct people in line management and in matrix management environment;
  • Strong collaborative skills and the ability to thrive in a science-driven organization;
  • Excellent listening skills; seeks broad input and feedback;
  • Executive presence with ability to communicate the vision of GBT and a passion for science-based brands that can dramatically improve patients’ lives;
  • Well-organized, high energy, detail oriented, and persistent; can identify/focus on key issues, prioritize efforts and ensure follow up with timely/quality results;
  • Able to leverage one’s understanding of the external environment to anticipate future trends, identify risks and create opportunities for GBT;
  • Excellent presentation and communication/negotiation skills with an ability to efficiently and productively communicate both orally and in writing at all levels;
  • The highest ethics and moral standards; unquestioned integrity.

Work Environment:

  • Zug, Switzerland-based position;
  • Travel is estimated to be 20-30%, with the majority being within Europe but occasional travel to the USA.

Fit with GBT culture:

  • Ability to build strong relationships with co-workers of various backgrounds and expertise;
  • Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor;
  • Values-based leadership consistent with GBT's Core Values;
  • Excitement about the vision and mission of GBT;
  • Flexibility;
  • Integrity.

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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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