The Opportunity:
The TA Lead has significant responsibility and impact. The position will be instrumental in forming strategic partnerships with the respective business leads/TA leads. The TA Lead will lead and oversee the global management of intellectual property matters as well as provide strategic guidance to advance the TA IP assets and create commercial business value and commercial security and confidence.
This role is integral to developing, defending, and enforcing the organization's global TA patent portfolio, developing and enforcing the global TA's Regulatory exclusivities' portfolio, as well as ensuring compliance with intellectual property laws, thereby supporting the company's broader business objectives.
You will lead and support all IP aspects of deals planned and executed by the TA's. You will partner with the TA lead and associates on developing life cycle management and life cycle initiatives which involve IP amongst other things.
The Vaccines TA lead may also act as Head of Seqirus IP and primary point of contact for Seqirus management (if required).
The Role:
- Strategic advisor to the IP function and key IP partner for CSL Therapeutic Area Leadership teams and TA-aligned development and commercial stakeholders (Immunoglobins, Vaccines, Hematology, Cardiovascular Renal, Immunology & Transplant) as well as to the corresponding commercial BU stakeholder.
- Responsible for setting, managing, and delivering on IP strategy and other enterprise-wide IP objectives to TA Leadership Team and senior BU stakeholders as well as other key stakeholders for TA-aligned products, including relating to clinical development, commercial activities, parallel import, exclusivities (regulatory data exclusivity, orphan drug exclusivity, pediatric exclusivity, PTE/SPC), labelling, life cycle management, country support, communications, patent listings, and LoE preparedness.
- Managing a specialized team of TA-aligned patent attorneys, senior patent attorneys, IP lawyers, scientists, and life sciences lawyers to deliver enterprise-wide IP strategy supporting CSL Therapeutic Areas and TA-aligned activities and developing life cycle initiatives to actively contribute to the TA's value creation and long-term projection.
- Within a matrix work model, leading and managing a cross-functional team of attorneys and IP experts to deliver IP strategy and advice (as required) to management and other stakeholders.
- Overseeing and supporting the prosecution and leading defense of CSL intellectual property, including the identification and safeguarding of inventions relating to TA-aligned products and activities (SG2-SG7), management of TA-aligned patent portfolio with respect to pending applications and granted patents taking into account national and international law and guidelines.
- Key business partner for senior leadership, commercial and R&D divisions in assessing and leading and strategically managing potential IP challenges relating to TA-aligned development and commercial products. Strategic lead, oversight and input for patent disputes, including patent office challenges as well as court litigations (infringement and revocation lawsuits) relating to TA-portfolio products; advising Head of IP, CSL Legal Leadership team and senior stakeholders and instructing external counsel on such matters as needed.
- Provide counsel and IP advice to CSL Strategy team and TA-leadership team and assess business impact of a potential asset from an IP perspective, including global licensing and business development, in due diligence, deal teams, and negotiation of agreements, such as licensing & M&A.
- Advises and represents the organization on legal issues concerning patent and related IP Issues, especially relating to TA-aligned products and TA-led activities.
- The Vaccines TA lead may also act as Head of Seqirus IP and primary point of contact for Seqirus management (if required).
Key Relationships (both internal and external):
- IP team, including Head of IP and IP Leadership Team.
- Therapeutic Area Leadership Team (TALT).
- Commercial Development.
- Clinical Development.
- Global Regulatory Affairs (GRA).
- Safety / Tox.
- Strategy / Global Licensing for TA-led activities.
- Product Strategy Teams (PST), where required.
- Global Brand Teams (GBTs), where required.
Skills & Experience:
- Master's degree in life sciences discipline (chemistry, biochemistry, biotechnology) or a related field, preferably a PhD, or equivalent experience in scientific research.
- Qualified Patent Attorney or IP lawyer admitted to practice in the US or equivalent legal qualifications and experience in Intellectual Property.
- At least 12 years post-qualification experience in Intellectual Property.
- At least 5 years of experience with life science technologies and operations of in-house IP teams with a background in a technical field relevant to CSL, especially therapeutic areas of interest (Immunoglobins, Vaccines, Hematology, Cardiovascular Renal, Immunology & Transplant).
- Proven experience in managing an in-house IP team, preferably in pharmaceutical or biotech field.
- Proven experience in due diligence, life cycle management, IP challenges and/or negotiations. This role may require travel, especially to CSL sites in Europe, US, and Australia.
Competencies:
- Proven leadership skills, focused on building bridges and empowering teams.
- Leadership competencies that include strategic thinking, integrating external factors into patent strategy, team building, talent cultivation, and coaching.
- Demonstrated business acumen with the ability to provide actionable and strategic advice. Ability to initiate, drive, lead and shape IP strategy.
- Excellent organizational and planning skills and ability to deliver work to tight deadlines (if required).
- Capacity to foster environments that enhance decision-making and appropriate risk-taking, especially in patent-related matters.
- Superior verbal and written communication skills, adept at simplifying complex concepts for business partners.
- Strong interpersonal skills with the capacity to effectively interact with diverse groups, key internal functions, senior management, external partners, and build great relationships with people across a global business.
- Agile learner, quickly adaptable to new situations and challenges.
- Thinks beyond and incorporates external factors into business strategy.
- Builds bridges and empowers One-CSL teams.
- Unleashes outcomes and creates an environment of decision making and appropriate risk-taking.
- Ignites agility and creates a nimble environment.
- Inspires the future and drives the strategy throughout the organization.
- Cultivates talent and takes proactive steps to secure future talent.
- Problems faced often complex and undefined, requiring broad-based solutions to implement changes for area of responsibility.
- Requires ability to influence others, negotiate and compromise, and ability to communicate and influence senior executive leadership.
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