ROW IP Litigator and Regulatory Exclusivity Expert
The position is for an IP and Regulatory exclusivity (Pharmaceutical Incentives) senior lawyer. The position includes providing advice, assistance and leadership on regulatory issues which are integral part of the exclusivity position of a product, in particular regarding regulatory exclusivities, developing strategies that will create synergies with IP exclusivities to optimize life cycle management (LCM), the optimal creation of exclusivities for development/pipeline products and the loss of exclusivity (LoE) position of CSL’s products.
This IP lawyer will coordinate complex regulatory exclusivity and other related activities , e.g. LoE strategies, taking into account the IP landscape and broader political and commercial environment.
This position reports to the head of IP and is a member of the enterprise global IP leadership team.
The Role
Be up-to-date with Regulatory and Pharmaceutical Incentives legislations in EU and new regulatory developments globally to ensure proper implementation across the global IP organization
Support the global IP organization with respect to the implementation of the new EU Pharma legislation package and EU transparency rules
Design and support implementation of life cycle management (LCM) strategies and loss of exclusivity (LoE) strategies with a focus on the regulatory exclusivity aspects in collaboration with IP team member(s) and business partners
Design and support periodic exclusivity reviews to our pipeline/development products to maximize the length and strength of regulatory and IP exclusivities
Advise on patent litigations strategies with an emphasize of regulatory exclusivity linkage
Ensure the global IP organization takes consistent approaches towards life cycle management (LCM) strategies and loss of exclusivity (LoE) strategies.
Design and coordinate implementation of collaboration streams with Global Regulatory and R&D to secure/maximize value creation (Patent Term Extensions, Patent Linkage, Paediatric Extension, review of critical registration dossier sections)
Guide patent drafting and prosecution on the basis of regulatory and pharmacovigilance innovation such as risk management plans, side effects and percations;
Build a LCM/LoE functional team that works together on challenging problems and provides mutual support.
Conceive and execute RoW IP litigation strategies in collaboration with other team members
Directly manage certain RoW IP disputes or Pharmaceutical Incentives disputes
Negotiate settlements and license agreements
Advise RoW business partners regarding IP strategy and litigation risk
Build RoW IP litigation functional team that works together on challenging problems and provides mutual support
Support professional development of functional RoW IP litigation team members, including through mentoring, coaching, continuing legal education, and sharing of best practices
Ensure RoW IP litigation team takes consistent approaches towards handling cases
Manage governance and reporting of RoW IP litigation
Manage RoW IP litigation budget
Monetize IP assets via licensing and, if necessary, patent enforcement
Collaborate effectively across functions with multiple stakeholders
Skills and Experience
Experience/Education
At least 15+ years ex-US IP litigation experience with focus on biologics IP litigation (brand on brand or biosimilar)
At least 10+ years experience in life cycle management and loss of exclusivity strategizing
At least 10+ years experience in handling complex IP incentives and regulatory strategies or disputes
At least 10+ years experience litigating and resolving IP and regulatory exclusivity related contract disputes
At least 10+ years experience monetizing IP assets
Experience leading team of in-house IP lawyers
Critical Competencies
Excellent understanding of IP, Pharmaceutical Incentives and associated regulatory legislations
Strong experience in developing and implementing life cycle management and loss of exclusivity strategies
Demonstrated ability to achieve optimal results in IP litigation cases; experience in Pharmaceutical Incentives/Regulatory exclusivity disputes of advantage
Excellent negotiation skills
Ability to solve complex and challenging problems
Practical and creative mindset
Demonstrated business acumen and ability to deliver useful advice
Superior verbal and written communication skills and ability to communicate complex concepts to business partners in an understandable way
Sound judgment
Strong interpersonal and team player skills and the ability to effectively interact with people from diverse backgrounds
Ability to prioritize and effectively handle multiple projects at the same time
Comfortable working on teams and independently
Agile learner capable of stepping quickly into new situationsLeadership competencies, including strategic thinking, building and optimizing teams, and developing, mentoring, and coaching team members
CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.
Please take the time to review our benefits site to see what’s available to you as a CSL employee.
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.
As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
