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, Associate General Counsel opportunity at their new affiliate Audentes in San Francisco, CA.
Purpose & Scope:
The Senior Director (Associate General Counsel), Legal Audentes is a key strategic leader responsible for providing practical, timely, strategic, and high-quality legal advice across a breadth of complex legal matters in regard to the Company's activities, supporting primarily Audentes, the President of Audentes and other senior leaders, as well as a broad spectrum of clients throughout the organization. This position will participate and take leadership roles in cross-functional teams, identify legal issues, provide legal options and analysis of possible legal solutions, and give recommendations for addressing critical issues so that business and legal objectives are met. This is a highly strategic position and is accountable for supporting the achievement of the Company's Corporate Strategic Plan ("CSP"), proactively identifying and mitigating risks to the Company's ability to achieve its objectives under the CSP, and balancing opportunities with associated legal and compliance risks in a complex and fast-evolving regulatory environment. In addition, given the critical aspect of innovation in the CSP and the growth, complexity and depth of Audentes, this position also directly impacts the Company's ability to achieve its goals and objectives.
Essential Job Responsibilities:
This position will have the following responsibilities, working closely with the Legal Head of CRMDT and the Innovation & Research Lead:
- Serving as a strategic legal partner to Audentes, Audentes' senior leaders as well as the other global business leaders and their teams by providing timely, proactive, strategic, best-in-class legal advice and support, taking into account the global objectives of the organization and the unique and varying global, local and regional legal and regulatory requirements in a risk-balanced manner in order to effectively minimize and mitigate risk. In this regard, the Senior Director (Associate General Counsel), Legal Audentes will also align, coordinate and work closely with other members of the Legal and IP-INV and BD teams as may be needed or appropriate.
- Proactively support all operational functions within Audentes, including Research, Clinical Development, Medical Affairs, Project Management, Commercial, Manufacturing, Quality, Communications, Finance and HR.
- Strategically drafting, negotiating, and consummating a broad range of complex agreements, including research collaborations and alliances, consortiums, sponsored research, material transfers, research licenses, HTS library exchange, consulting services, research services, CRO services, advisory boards and councils, data sharing and data licensing, investigator-initiated studies, regulatory and quality agreements, distribution agreements, license agreements, asset purchase and sale agreements, professional services agreements, confidentiality agreements, vendor agreements, advertising and promotional agreements and consulting agreements.
- Collaborating with the Legal Head of CRMDT to oversee advice and support throughout the Legal team that may be connected and/or related to the work of other teams in Legal including Affiliate lawyers in the US, Established Markets, International, Japan and Greater China Divisions (collectively referred to as the "Divisions"). "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 Legal Lead of Innovation and Research and his/her team ("I&R Team") (collectively, "Local Matters"). With respect to all Local Matters, the Legal Head of CRMDT Team and the I&R 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)/Commercial Lead for the Divisions and the I&R Team will vary depending on its materiality and complexity as determined by the Legal Head of IGTD in consultation and coordination with the applicable Commercial Lead 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 Legal Head of ILE and the ILE Team. The ILE Team will closely collaborate with the Legal Head of CRMDT and he/she will communicate as appropriate to the Legal Commercial Lead of the relevant Divisions.
- Collaborating with the Rx+/Transactional Legal team on innovation related transactions as determined by the Legal Innovation & Research Lead and Legal Rx+/Transactional Lead.
- Providing updates to senior leaders in Audentes, as well as other senior management and business clients on changes in legal developments affecting the pharmaceutical and biotech industries, and the innovative new technologies under the CSP and coordinating with other leaders in the Legal function, as may be appropriate.
- Identifying, participating in and contributing to contract enhancement initiatives, in close collaboration and coordination with global contracting Legal leaders and senior business stakeholders.
- Supervising and developing Audentes' Paralegal and other professionals to assure timely, proactive, strategic and high quality legal advice.
- Identifying key legal issues requiring attention from Legal Head of CRMDT as appropriate.
- Coordinating and working closely with the Legal and IP function, as well as the IP-INV function for all matters in connection with or related to Audentes, handled by the Legal Research and Innovation Team.
- Coordinating and working closely with the Corporate Communications function on all matters for all matters in connection with or related to Audentes, handled by the Legal CRMDT and Research and Innovation Teams.
- Working with the Legal Head of CRMDT, Research and Innovation Lead, and other members of the Legal Team to anticipate potential legal issues for Audentes with respect to matters supported by the Legal CRMDT Team and develop strategies to mitigate risks.
- Working with Legal Head of CRMDT and Research and Innovation Lead to make strategic decisions regarding legal arguments and positions taken in connection with legal matters and activities supported by the Legal CRMDT and Research and Innovation Team.
- Working with outside counsel, ensuring efficient and effective use of outside counsel, and coordinating with Legal Research and Innovation Lead, other members of the IGTD Team, and members of the CRMDT Team.
- As may be directed by Legal Head of CRMDT , preparing, overseeing and managing the budget for a particular transaction, including management of outside counsel fees consistent with applicable budgets; working creatively with outside counsel to minimize fees and costs. Management of such outside counsel shall be in close cooperation with Legal and IP Operations.
- Working collaboratively with a broad range of people and functions throughout the organization to develop and maintain strong working relationships across all functional areas to facilitate a partnering-based approach.
- Coordinating closely with global Ethics & Compliance colleagues.
- Reviewing, analyzing and keeping current on relevant legal developments affecting the pharmaceutical and biotech industries.
- Supporting the Legal Head of CRMDT Lead to develop legal training specific to issues and matters supported by the Legal CRMDT Team; identify training needs within client groups and assist in the development and presentation of training for such issues.
- Supporting the Legal Head of CRMDT in leading a Culture of Excellence for the Legal Research and Innovation Team which includes driving and fostering: (1) an agile, adaptive culture; (2) a value-based organization based on Legal's Mission, Strategic Plan 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 Legal Research and Innovation Team members; and (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) continuous expectation of high performance, where "ok" is not good enough
- Other projects as may be requested by Legal Head of CRMDT .
- Overnight travel, including international travel, as needed.
- Reports to Legal Head of Commercial, Regulatory, M&D and Rx+/Transactional ("CRMDT") .
- Member of Legal CRMDT Team.
- Dedicated legal resource in San Francisco office providing full range of legal support to Audentes,. This position will be supported by other members of the Legal CRMDT and Legal Innovation and Research Teams.
- Serves as the primary legal support for Audentes activities in the US.
- Works closely with senior leadership of Audentes.
- Works closely and collaborates with other members of the Legal and IP Innovation and New Technologies ("IP-INV") and Business Development ("BD") teams, as necessary or appropriate.
- Works closely and collaborates with colleagues at local, Divisional and global levels.
- Works closely and coordinates with other members of the CRMDT Team, as well as other members reporting into the Legal Head of Innovation, Governance, Technology and Data (the "IGTD Team").
- Juris Doctorate degree with at least 10-12 years of professional experience in a large law firm or corporate setting.
- At least 7 years of diverse pharma, biotech or life sciences legal experience, including substantial experience working with biotech companies; rare disease experience is preferred.
- Solid experience and knowledge of best practices relating to providing a broad range of legal support in the pharmaceutical and biotech industries. Deep understanding of the legal issues affecting the pharmaceutical industry, with a particular focus on early stage research and innovation, research collaborations, as well as 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, Medical Affairs, Manufacturing, Quality, R&D, regulatory and commercial elements.
- 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.
- Solid negotiation and communication skills (both oral and written). Ability to communicate legal issues in a clear and understandable manner.
- 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 with demonstrable ability to build relationships both internally and externally.
- Strong organizational skills, detail oriented, innovative, strategic, self-motivated and able to motivate others.
- A strong commitment to integrity and professionalism and demonstrated passion for excellence.
- Models Audentes Core Values: Be Bold, Care Deeply, #GetStuffDone - is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted.