Lead Counsel, R&D Business Development
Location Boston, Massachusetts
Lead Counsel, R&D Business Development
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as the Lead Counsel, R&D Business Development in our Boston office.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
- Serve as senior legal advisor for Oncology Business Unit to appropriately execute oncology strategy and brand objectives
- Lead and manage the overall legal risk assessments to ensure appropriate and comprehensive understanding of potential enterprise risk, escalation, and resolution
- Collaborate with other brand attorneys, IP, Compliance, Regulatory and other business groups to ensure robust, integrated and complete client counseling.
- Provide focused legal support, in collaboration with other attorneys, for global oncology commercial and late stage development products
- Serve as legal advisor/core brand attorney to commercial, medical affairs, market access, distribution and development teams, as assigned, for late stage products and marketed products
- Lead assigned cross-functional legal initiatives and serve as lead lawyer on cross-functional commercial teams including without limitation, brand team, promotional and other material review committees and medical drug information
- Collaborate with R&D, IP, Compliance colleagues involved with late stage clinical and marketed products with responsibility for ensuring an aligned approach across multiple products
- Review business materials (including brand plans, promotions, medical plans, training documents) requiring legal input and advising internal clients, partners and stakeholders on compliant strategies, plans and tactics;
- Advise cross functional teams including clinical, product development, regulatory, medical affairs, and other clients on FDA regulatory submissions, label negotiations and privacy and data use.
- Counsel on appropriate relationships with a variety of external parties, including healthcare professionals, patients, academic institutions, and payors.
- Work collaboratively with Compliance colleagues to develop and implement training to internal clients, partners and stakeholders on key policies, procedures, practices and requirements for healthcare and related legal compliance and educate clients and partners about current enforcement trends.
DIMENSIONS AND ASPECTS
Technical/Functional (Line) Expertise
- Significant expertise in all areas of U.S. laws and regulations including FDA, anti-kickback, antitrust, privacy, product liability, and transactional work
- Experience acting as a cross-functional legal Franchise lead with accountability for all legal advice
- Serve as a senior legal member of global product teams or senior legal advisor to therapeutic area or discovery leadership teams contributing business and legal expertise/guidance to product development and strategy
- Maintain an enterprise view in developing and delivering legal guidance to client base
- Lead educational sessions for legal group and company
- Select and manage external counsel and associated spend
Decision-making and Autonomy
- Ability to advise on risk based decisions involving significant risk to company reputation and financial risk and to act with a high degree of autonomy and to act globally
- Manage outside counsel as needed
- Significant cross functional interaction at all levels of the company including cross functional global teams
- High level of legal innovation and cross functional capacity; ability to lead and think beyond “legal” and to lead cross functional innovative initiatives
- Experience in navigating successfully in a highly matrixed global work environment
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- 10+ years of experience in pharmaceutical in-house commercial product matters.
- Experience supporting a pharmaceutical commercialized brand required.
- Excellent oral and written skills
- Self-motivated, strong leadership, work well independently on projects, meet aggressive deadlines, handle multiple projects, technical knowledge, business acumen, and excellent communication skills
- Sound conflict resolution skills and ability to work in a collaborative, global environment
- Effective decision making; proven ability to assess and calibrate and effectively communicate legal risks to senior management and others.
- J.D., licensed to practice law in the U.S.
- Active membership and in good standing in a state bar
- 20% travel may be required
WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution Plan
- Tuition reimbursement Company match of charitable contributions
- Health & Wellness programs including onsite flu shots and health screenings
- Generous time off for vacation and the option to purchase additional vacation days
- Community Outreach Programs
Empowering Our People to Shine
Discover more at takedajobs.com
No Phone Calls or Recruiters Please