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)

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