Head of Biosimilars

Can you imagine leading the charge in transforming the biosimilars landscape? Zentiva is seeking a strong leader to drive the end-to-end strategy for biosimilar product development and commercialization. In this pivotal role, you’ll drive innovation, collaboration, and excellence, positioning our organization as a market leader in biosimilars. Partnering with internal teams and external stakeholders, you’ll play a key role in bringing life-changing therapies, aligning each milestone with our overarching business goals. If you’re passionate about making a tangible impact in healthcare, this is your opportunity to lead the charge.

MAIN ACCOUNTABILITIES AND DUTIES

Strategic Leadership:

• Develop and execute the biosimilars strategy within the generics pharma framework, aligning with the company’s long-term objectives for product portfolio diversification.
• Identify high-value biosimilar opportunities based on market trends, competitive dynamics, and the evolving regulatory landscape.
• Set and monitor key milestones, ensuring that the biosimilars division achieves its targets related to development, regulatory submissions, and market entry.

Product Development and R&D:

• Oversee biosimilar product development from early-stage research to clinical trials, ensuring alignment with regulatory and quality standards.
• Collaborate with internal R&D teams to drive product development and ensure adherence to timelines, quality standards, and cost-effectiveness.
• Keep track of advancements in biosimilar science, global competition, and manufacturing technologies to maintain a competitive advantage.

Regulatory Affairs and Compliance:

• Lead regulatory strategy, ensuring that biosimilar products meet global regulatory requirements (FDA, EMA, etc.) for approval.
• Liaise with regulatory bodies and ensure smooth regulatory submissions and approvals.
• Ensure compliance with Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and other relevant biosimilar guidelines, mitigating any regulatory risks.

Commercial Strategy and Market Entry:

• Develop the commercialization strategy for biosimilar products, including market access, pricing strategies, and payer negotiations, tailored for a generics pharma environment.
• Coordinate with marketing, sales, and market access teams to build market penetration strategies that leverage the company’s existing generics infrastructure.
• Ensure strong relationships with key payers, healthcare providers, and decision-makers to facilitate rapid adoption of biosimilar products.

Cross-functional Leadership and Collaboration:

• Lead cross-functional teams, including R&D, Regulatory, Supply Chain, Legal, and Commercial teams to ensure successful product development and launch.
• Work closely with Business Development teams to identify and establish partnerships, licensing agreements, and collaboration opportunities.
• Collaborate with manufacturing teams to ensure scalable, cost-efficient production of biosimilars, optimizing the company's generics manufacturing capabilities.

Operational Excellence:

• Manage the budget and resources for the biosimilars division, ensuring cost-effective operations while maintaining quality standards.
• Implement performance tracking systems and KPIs to monitor product development progress and market performance of launched biosimilars.
• Optimize supply chain and production processes to ensure timely availability of biosimilars in the market.

Team Leadership and Development:

• Lead and mentor a multidisciplinary team involved in biosimilar R&D, regulatory, and commercial functions.
• Foster a collaborative, results-driven work environment that encourages innovation and continuous improvement.
• Ensure continuous learning and professional development of team members to stay ahead in a competitive biosimilars market.

Market Insights and Competitive Intelligence:

• Monitor global biosimilar market trends, competitor activities, and new scientific advancements to inform strategic decisions.
• Regularly assess the competitive landscape, payer policies, and health economics to adjust market strategies and capitalize on new opportunities.

External Representation and Industry Networking:

• Represent the company at biosimilar industry forums, conferences, and regulatory meetings to advocate for the company’s biosimilars business and build brand equity.
• Cultivate relationships with key opinion leaders (KOLs), regulatory authorities, and other external stakeholders.

REQUIRED QUALIFICATIONS & EXPERIENCE  

• Advanced degree (PhD, MD,  or equivalent) in biotechnology, pharmacology, or related life sciences. MBA of advantage.
• 10+ years of experience in the pharmaceutical or biopharmaceutical industry, with a focus on biosimilar or biologics development.
• Extensive knowledge of biosimilar development, manufacturing, regulatory requirements, and commercialization within a generics framework.
• Proven track record of managing biosimilar products from development through regulatory approval to market launch.
• Strong understanding of global regulatory pathways for biosimilars (FDA, EMA, etc.) and market access strategies for generics.
• Experience in generics pharma, with knowledge of cost-optimization strategies and the competitive dynamics of the generics market.
• Familiarity with intellectual property (IP) landscapes relevant to biosimilars and biologics.
• Strong industry network with key stakeholders in biosimilar and generics pharma
• An original thinker with ability to lead effectively project teams
• Excellent leadership skills, organizational capability and the ability to foster opportunities for talent development
• Strong change management skills and experience, to develop and drive an organisation focused on excellence
• Fluent in English (written and spoken)