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Senior Director – Legal Medical and Development Regulatory

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Posted a month ago United States Salary undisclosed

Job Description

Title: Senior Director, Legal Medical and Development Regulatory – Associate General Counsel

Location: Remote, US

Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture.

There’s something special about working at Astellas. It’s reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.

Astellas is announcing a Senior Director, Legal M&D Regulatory (Associate General Counsel) in Northbrook, IL with consideration for remote.

Purpose & Scope:

The Senior Director, Legal M&D Regulatory is responsible for managing a breadth of complex legal and legal regulatory matters for Medical Affairs Americas and the global Development organization, including Oncology Development, Medical Specialties Development, Ophthalmology Development, Clinical Science, Regulatory, and Pharmacovigilance, by providing practical, timely, strategic and high-quality legal advice to a broad spectrum of clients across the M&D organization.

This is a highly strategic position and is accountable for balancing global development opportunities with associated legal and compliance risks in a complex and fast-evolving regulatory environment. This position is also accountable for proactively identifying and mitigating risks to the Company’s ability to achieve its corporate objectives under the Corporate Strategic Plan (“CSP”). In addition, given the increase in clinical development activities in Greater China and other markets as well as an increase in complex development collaborations with other pharmaceutical companies, academic institutions, healthcare organizations and government bodies, this is a highly strategic position with a significant impact on the Company’s ability to achieve its development program goals and objectives.

Essential Job Responsibilities:

The Senior Director, Legal M&D Regulatory will have the following responsibilities:

  • Serving as a strategic legal partner to global business leaders in the Development organization and regional business leaders in Medical Affairs Americas and their teams by leading, managing and overseeing the full range of legal support, advice, and counseling, including providing timely, proactive, strategic, best-in-class legal advice and support, taking into account the global objectives of the organization, the CSP and the unique and varying global, regional and local legal and regulatory requirements in a risk-balanced manner in order to effectively minimize and mitigate risk. In this regard, the Senior Director, Legal M&D Regulatory will also align, coordinate and work closely with other members of the Legal and IP Legal teams as may be needed or appropriate.
  • Leading, managing, and overseeing the strategic drafting, negotiation and consummation of a broad range of complex M&D-related agreements, including agreements for collaboration and combination studies, clinical trials, expanded access, compassionate use, patient recruitment, informed consents, non-interventional studies, sponsorships and grants, advisory boards, data sharing and data licensing, investigator-initiated trials, and regulatory, quality, and pharmacovigilance agreements.
  • Serving as a key strategic advisor and partner to the Head of Development, the Head of Medical Affairs Americas and their leadership teams, as well as a member of the Americas Medical Affairs and/or Development Leadership Teams.
  • Leading, managing, and overseeing the full range of legal regulatory support for clinical development and medical affairs activities throughout the life cycle of all compounds and products. Such support includes providing legal advice, including the legal interpretation of laws, rules, regulations and guidance documents relating to the development of pharmaceutical products.
  • Together with the Legal Regulatory Leads, contribute to the establishment of governance and processes to develop a globally consistent approach to Legal Regulatory support taking into account unique aspects required for a particular client group as well as specific legal requirements of the countries in which the M&D organization operates.
  • Overseeing and providing updates to senior management and business clients in M&D on changes in legal and regulatory developments affecting the pharmaceutical industry, coordinating with other leaders in the Legal function as may be appropriate.
  • Collaborating with Affiliate lawyers in the U.S, Established Markets, International, Japan and Greater China Divisions (collectively referred to as the “Divisions”) to provide M&D-related advice and support. “Affiliate lawyer” means a lawyer based in an Astellas office outside of the office locations in Tokyo, London and Chicago who reports to/through one of the Legal Commercial Leads for the Divisions. Specifically with respect to the Affiliate lawyers in the Divisions, there is a recognition and understanding that these lawyers provide general legal support to their respective General Managers and Affiliate leadership teams which often goes beyond commercial and back office support, including support for various local matters covered by the Senior Director, Legal M&D Regulatory and other attorneys who support the Medical & Development organization and report to the Legal Regulatory Lead for Oncology, Innovation, and Patient Centricity (“M&D Team”) (collectively, “Local Matters”). With respect to all Local Matters, the Senior Director, Legal M&D Regulatory and the M&D Team will work closely and coordinate with the respective Legal Commercial Lead for the relevant Divisions and the relevant Affiliate lawyers to determine who will lead a particular matter and otherwise assure that such Local Matters are handled consistently with global policies and practices taking into account unique local or regional legal requirements that may exist (or the General Counsel will so determine in the event there is no consensus). The level of involvement and extent of coordination and collaboration on a Local Matter between the applicable Affiliate lawyer(s)/Legal Commercial Lead and the M&D Team will vary depending on its materiality and complexity as determined by the Legal Regulatory Lead for Oncology, Innovation, and Patient Centricity in consultation and coordination with the Legal Commercial Leads for the Divisions and Legal Head of CRMDT. Notwithstanding the foregoing, if a Local Matter is an investigation (internal or third party), any such investigation will be led by the ILE team. The ILE team will closely collaborate with the Legal Head of IGTD and Legal Head of CRMDT. The Legal Head of CRMDT will communicate as appropriate to the Legal Commercial Lead for the relevant Division(s).
  • Representing the Legal department on various senior management cross-functional global committees.
  • Leading, managing and developing or partnering with a global team of highly skilled and specialized lawyers and other professionals in multiple jurisdictions to assure timely, proactive, strategic and high quality legal advice.
  • Assisting the Legal Regulatory Lead for Oncology, Innovation, and Patient Centricity and the Legal Head of CRMDT in reporting to the General Counsel, top management and the Board of Directors of Astellas Pharma Inc. (“API”).
  • Coordinating with Centers of Excellence (“COEs”) in the General Counsel group as may be appropriate or needed.
  • Retaining, supervising and directing outside counsel effectively, and efficiently managing legal expenses consistent with global budget for legal Regulatory matters, coordinating closely with Legal & IP Operations.
  • Coordinating closely with global Ethics & Compliance colleagues.
  • Acting as a member of legal-related industry or business community committees such as JPMA, PhRMA, EFPIA, APBPI or other regional or local bodies.
  • Leading a legal culture of excellence in his/her team, which includes driving and fostering: (1) an agile, adaptive culture; (2) a value-based organization based on Legal’s Mission and objectives; (3) a culture of innovation, transparency and trust; (4) proactive identification/mitigation of risk in a balanced approach; (5) empowerment and engagement of the team members; (6) a collaborative culture with close coordination with other members of Legal and IP as appropriate to leverage synergies and efficiencies; (7) a culture of compliance and good corporate governance; and (8) a continuous expectation of high performance, where “ok” is not good enough.
  • Leading other projects as may be requested by the Legal Regulatory Lead for Oncology, Innovation, and Patient Centricity, Legal Head of CRMDT, or General Counsel.
  • Overnight travel, including international travel, as needed.

Organizational Context:

  • The Senior Director, Legal M&D Regulatory reports to the Legal Regulatory Lead for Oncology, Innovation, and Patient Centricity.
  • Member of leadership team of Legal Regulatory Lead for Oncology, Innovation, and Patient Centricity.
  • Member of the leadership team of Medical Affairs Americas.
  • Responsible for providing full range of legal support for all legal matters involving the global Development organization and serving as the legal lead for Medical Affairs Americas, working closely with senior leadership in all functions across the Astellas enterprise, including Commercial, DDR, Research Affiliates, Development, Medical Affairs, Rx+, Business Development, and Shared Services.
  • Works closely, collaborates and coordinates with the other teams reporting into the Legal Head of Commercial, Regulatory, M&D and Rx+/Transactional (“CRMDT”) (including, in particular, the Legal Regulatory Lead for Medical Specialties, Market Access, PV and Quality) and the Legal Head of Innovation, Governance, Technology and Data (“IGTD”); as well as the Legal Heads of Investigations, Litigation and Employment (“ILE”); IP Legal and Legal & IP Operations.

Qualifications:

Required

  • Law Degree.
  • At least 10-12 years’ experience working in a law firm or pharmaceutical legal department.
  • Sophisticated understanding of US litigation process and procedures, including e-discovery and document preservation obligations, as well as familiarity with such processes and procedures in other countries in the Divisions as well as in Other Commercial Divisions.
  • Deep understanding of the legal issues affecting the pharmaceutical industry, including regulatory processes for prescription drugs, anti-kickback, fraud and abuse, anti-bribery and anti-corruption and antitrust laws. Strong knowledge of global regulatory environment that affects decision-making across Astellas’ global business. In-depth understanding of the pharmaceutical industry, including IP, manufacturing, R&D, regulatory and commercial elements.
  • Ability to effectively and strategically lead a broad-based legal function in a complex multi-jurisdictional environment for a multinational pharmaceutical company. Strong experience and knowledge of best practices relating to employment matters in the various countries comprising the Divisions.
  • Strong ability to grasp legal issues quickly, exhibit strong analytical problem solving and decision making skills, exercise sound judgment, and provide practical and constructive legal advice in a time-sensitive, dynamic, and fast-paced complex global environment.
  • Strong management and leadership skills, including the ability to effectively motivate and manage a broad-based team.
  • Strong negotiation and communication skills (both oral and written). Ability to communicate legal issues in a clear and understandable manner. Inspires trust and confidence through effective communication and interpersonal skills.
  • Strong work ethic and ability to manage large workload, multi-task, focus on critical priorities, and otherwise effectively meet client needs. Ability to produce high quality work under deadline pressures.
  • Team player and able to build relationships, both internally and externally, on a global scale.
  • Strong organization and teamwork skills. Detail-oriented, self-motivated and able to motivate others.
  • A strong commitment to integrity and professionalism and demonstrated passion for excellence.