Senior Counsel,

Purpose & Scope:

The Associate Director, Legal M&D Regulatory is a key legal advisor responsible for managing a breadth of complex legal matters for the global Medical and Development organization, including Oncology Development, Medical Specialties Development, Medical Affairs, 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 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”).

Essential Job Responsibilities:

·         Serving as a strategic legal partner to global business leaders in the M&D organization and their teams by providing a full range of 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 Associate 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.

·         Analyzing complex issues and concepts on a timely basis and memorializing them in well-developed agreements and arriving at balanced solutions in contract negotiations. The Associate Director, Legal M&D Regulatory will work collaboratively and creatively with internal clients to provide broad-spectrum legal contracting support and other day-to-day counseling.

·         Serving as a strategic advisor in the negotiation and settlement of business disputes to avoid litigation and protect the company’s interests.

·         Providing updates to 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.

·         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 matters, coordinating closely with Legal & IP Operations.

·         Coordinating closely with global Ethics & Compliance colleagues.

·         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 Director, Legal M&D Regulatory; the Legal Regulatory Lead for Oncology, Innovation, and Patient Centricity; or the Legal Head of CRMDT.

Qualifications Required

·         Law Degree (Juris Doctor and licensed to practice law).

·         At least 5-7 years’ experience working in a law firm (life sciences practice) or pharmaceutical legal department.

·         Prior legal experience handling transactional legal and counseling matters for a company in the pharmaceutical or biotechnology industry.

·         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. Good understanding of the pharmaceutical industry, including IP, manufacturing, R&D, regulatory and commercial elements.

·         Strong experience and knowledge of best practices relating to legal matters in the pharmaceutical industry. 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.

·         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 and 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.

·         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.