Associate Director - IP

Job Summary

Azurity Pharmaceuticals is seeking an experienced and seasoned Patent Professional to join the expanding Intellectual Property (IP) team. The Associate Director – Intellectual Property (IP) will play a key leadership role in driving the development, protection, and commercialization of the company’s intellectual property portfolio. This position will support strategic IP initiatives, manage patent lifecycle activities, and collaborate with cross-functional teams to enable product development and market access. The ideal candidate will combine deep IP knowledge with business acumen, supporting cross-functional initiatives and managing the company’s innovative formulations across key global markets.

Key Responsibilities

1. IP Strategy & Portfolio Management

• Manage the IP portfolio, including patents and trademarks, across multiple jurisdictions.
• Lead the development and execution of IP strategies aligned with R&D and commercial objectives.
• Conduct thorough IP due diligence to support product selection, licensing, M&A, and strategic partnerships.
• Oversee patent life cycle management, including drafting, filing, prosecution, opposition, maintenance, and strategic abandonment.
• Guide new product opportunity identification through an IP lens, enabling lifecycle extension and exclusivity strategies.
• Develop and execute IP strategies aligned with business and product development goals.
• Manage and expand the patent portfolio across multiple geographies.
• Support lifecycle management strategies to maximize product exclusivity.

1. IP Due Diligence & Risk Management

• Perform prior art searches, patentability assessments, landscape analysis, and freedom-to-operate (FTO) evaluations.
• Analyze Orange Book-listed patents & Pending Patent Applications and develop IP strategies in compliance with regulatory and legal requirements.
• Generate risk assessment reports & provide IP clearances for proposed formulations, synthesis routes, polymorphs, and manufacturing processes.
• Analyze the IP to develop non-infringement and patent invalidation strategies, including prior art search and claim construction.
• Conduct IP landscape and freedom-to-operate (FTO) assessments.

1. Litigation Support

• Provide strategic support to the Legal team on patent litigations, including IPR (Inter Partes Review) and PGR (Post-Grant Review) proceedings.
• Develop claim construction and invalidity arguments, leveraging prior art and technical literature.
• Monitor ongoing litigations, especially within the U.S., and assess potential business impact.

1. Patent Drafting & Prosecution

• Oversee patent drafting, filing, prosecution, and maintenance activities.
• Work with external counsel to ensure high-quality filings and timely responses.
• Provide scientific and technical input to attorneys while responding to office actions.
• Review invention disclosures and guide teams on patentability considerations
• Monitor global patent filings and competitor activities

1. Cross-functional Collaboration

• Collaborate with the R&D team to identify patentable inventions and formulate patentable strategies.
• Partner with the R&D team to identify opportunities for differentiated product filings, including 505(b)(2) and ANDA strategies.
• Engage with relevant stakeholders (R&D, Regulatory, Clinical & Legal teams throughout the development cycle.
• Support the development of alternate or workaround strategies for blocking IP.

 

1. Market & Competitive Intelligence

• Continuously monitor market trends, IP filings, and competitive developments through SEC filings, earnings calls, and public disclosures.
• Conduct whitespace analysis and technology mapping to identify new opportunities.

1. Leadership & Team Management

• Lead and mentor a team of 1-2 IP professionals.
• Ensure efficient workflows across drafting, filing, and prosecution processes.
• Drive capability building within the IP function.

Qualifications

• Advanced degree in Pharmacy or a related scientific discipline.
• 14–16 years of relevant experience in Intellectual Property domain within the pharmaceutical industry, preferably with a focus on formulations.

Preferred Skills & Attributes

• Deep understanding of global patent systems and procedures (including Indian, US, EP, and PCT).
• Demonstrated expertise in patent analysis, drafting, prosecution, and litigation support.
• Exposure to P-IV litigations is highly desirable.
• Expertise in global IP law, with hands-on experience in patent filing, prosecution, and infringement/invalidity analysis.
• Strong command over FTO analysis, Orange Book navigation, and regulatory IP alignment (including 505(b)(2) applications).
• Excellent analytical, communication, and interpersonal skills with an ability to work effectively in cross-functional and global teams.
• Strong organizational and time management skills, with the ability to manage multiple priorities under tight deadlines.
• Strong analytical and problem-solving skills with a proactive mindset.
• Ability to lead and mentor teams by setting clear expectations, providing continuous feedback, and fostering professional growth.
• Strong interpersonal communication skills for effective cross-functional collaboration.
• Demonstrated ability to influence and negotiate within multidisciplinary teams.
• Comfort working across multiple time zones and adapting to a dynamic, fast-paced environment.