Global Head, Biologics Pharmaceutical Development

at  Roche

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.
The Position

Key Responsibilities and Accountabilities:

• Develop and preside over the implementation of all activities related to Pharmaceutical Product development for all pipeline products in the Pharma Technical Development Biologics portfolio.
• Provide strategic leadership and commit to the scientific excellence of the formulations and stability efforts to support early and late stage clinical studies, commercial launch and significant post-market modifications. This includes:
• Developing robust formulations and manufacturing processes
• Developing new technologies & innovative drug delivery approaches enabling future products, such as ocular products, co-formulated products, sustained release products and more patient focused dosage forms
• Identifying, prioritizing & overseeing formulation and DP processing technology development efforts in line with mid to long term business objectives and their conversion into mainstream approaches
• Provide oversight of the execution of drug product process characterization and validation programs in preparation for licensure with a focus on right the first time
• Oversight of equipment development and qualification activities
• Provide strategic leadership for molecule assessment in partnership with counterparts with Research & Early Development (gRED/pRED) organization, Analytical Development, and Drug Substance Development
• Work towards the digital transformation of the organisation to accelerate the development of product and process knowledge and to convert data to new product & process insights.
• Ensure capabilities and expertise is available to support all Drug Product programs.
• Provide scientific and business strategies to project teams and the Technical Research & Development community.
• Translate strategy into action: Inspire and lead others to communicate and act with a clear vision and purpose, connecting different perspectives; drive execution of strategies across PT and R&D community
• Collaborate effectively with partners in Device Development, Global MSAT and Global Product Strategy in developing aligned strategies and concepts for the development of drug product, drug delivery and devices.
• Build and maintain effective collaboration with gRED, pRED/LMR, PTD, GPD, GPS, and PT (Commercial Manufacturing, CGT, Quality, Supply Chain. Regulatory) to ensure seamless product development, process and knowledge transfer to clinical and commercial manufacturing operations and technical lifecycle management with a focus on continuous improvement and productivity, providing ongoing support where appropriate
• Cultivate compliance culture and instill internal and external requirements in all aspects of product development including cGMP and SHE
• Improve our business and deliver PT R&D budget by using financial insights and deliver PTD commitment (FTEs, Direct Expense, PVCs, Capex).
• Engage PTD in continuously improving productivity, performance and striving for excellence in development of biologics. Actively practice LEAN and to continue to eliminate waste in our processes. Leverage Lean Leadership to improve the system, process, efficiency, and capability in the organization and to accelerate our development work.
• Practice collective leadership with peer Technical Development function heads to ensure valued leadership of the Biologic global community as well as the South San Francisco, Basel, and Penzberg Technical Development communities
• Chair or Co-chair the Early Stage Technical Development Committee (ESTDC) for biologics, Large Molecule Technical Reviews (LMTR), and serves as a member of the Late Stage Technical Development Committee (LSTDC), and Early Stage Portfolio Committee (ESPC) and other global governance bodies as appropriate (e.g. Technology Portfolio Committee, CAPEX Committee

The leader must be customer focused and have a strong commitment to embracing network people capabilities and working collaboratively to advance Roche portfolio. As such, the leader will foster an environment of cross-functional collaboration, accountability, and technical rigor in collaboration with the R&D community. The successful candidate will have a demonstrated track record in recruiting and developing diverse leaders and being a good business and financial steward. The individual will provide active, visible leadership in advancing the portfolio and ensuring a positive external reputation.

• Ph.D. degree (preferably in Life Science or engineering) or equivalent work experience, and a minimum 15 years relevant experience in the pharmaceutical or biopharmaceutical industries, including 5 years leading highly technical organizations preferably in Pharmaceutical industry. (Pharmaceutical Development, Manufacturing Science and Technology, CDMO, etc.)
• Consistent track record of developing diverse, high performing organizations and teams with high standards for scientific excellence, driving innovation and operational effectiveness including safety, quality, compliance, and continuous improvement. Fosters inclusive cultures to ensure different perspectives, experiences, and knowledge are valued.
• Sets high standards and role models excellent people leadership including, coaching, talent development and performance management. History of developing people and technical leaders.
• Excellent communication skills with the ability to connect with and inspire staff at all levels and encourage direct and open dialog. Ability to convey controversial information and decisions as appropriate.
• Demonstrated ability to successfully lead complex organizations (e.g. multi-sites, multi-functional, etc), including people, financials and business processes and to provide focus and direction to navigate in fast moving environment
• Extensive knowledge and experience in multiple facets of technical development with sound judgment and decision making framework
• Outstanding knowledge of FDA regulatory guidelines and standards for biopharmaceutical process development and manufacturing and cGMP and SHE requirements practices
• Demonstrated customer and collaborator focus with strong relationship management. History of driving value through effective collaboration across multiple interfaces between technical, manufacturing, quality, regulatory and clinical functions. Ability to positively influence multi-disciplinary teams.
• Strategic with a broad understanding of the internal and external environment and application to strategy development. External influence is highly desirable such as experience leading external collaborations with partner companies, CMOs and academic institutions