Vice President Roche Bioinformatics Jobs in California

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The Vice President, Global Head Multiple Sclerosis and Neuroimmunology Product Development Clinical Science (PDC) and Disease Area Head (DAH) serves as the senior-most expert of Multiple Sclerosis and Neuroimmunology within PDC and has ultimate ownership and accountability of the DA's clinical development strategy. This individual is responsible for defining, leading, and overseeing the late stage strategic vision, including the clinical development strategy of Multiple Sclerosis and Neuroimmunology, and for providing inspirational leadership to the respective PDC Clinical Science team executing that strategy. Leveraging experience and mastery in influencing across a large, matrixed enterprise this individual provides disease area and development expertise to cross-functional life cycle teams, is the primary point of contact for business development activities in the specified DA, drives the implementation of a comprehensive end-to-end clinical development strategy, guides early and late-stage portfolio asset development and teams, and actively participates in and/or chairs relevant governance bodies. The GDAH is a critical cross-functional connector, working in close collaboration with the Roche Group Research and Early Development organizations, Roche Diagnostics, Pharma Partnering, Pharma Technical Operations, and Global Pharma Strategy teams.

Key Responsibilities

Global Strategy and Leadership

• Spearhead the assigned Disease Area in partnership with the GPS Disease Area Head (DAH). Together with the GPS DAH, establish and lead a fit-for-purpose DA Team with DA leaders from across the Roche Group.

• Together with the GPS DAH, this role is accountable for the definition and execution of the global end-to-end DA strategy, collaborating with Roche Group Research and Early Development organizations, Roche Diagnostics, and Global Pharma Strategy teams to provide disease area and technical expertise.

• Establish DA goals that serve the overarching strategic priorities, and ensure end-to-end prioritization of activities and implementation excellence.

• Represent late-stage development and contribute to the overall portfolio strategy with internal and external stakeholders, such as Research, Early Development, Roche Diagnostics, Medical Affairs, Commercial, Regulatory and Pharma Partnering senior leaders as well as health authorities, therapeutic area societies, patient advocacy groups, and key opinion leaders.

• Lead and/or define, in collaboration with functions across the drug development value chain, and in alignment with the DA strategy, asset strategies, clinical development plans, target product profiles, and clinical development stage transition decision criteria to ensure alignment with the DA strategy andachievement of the internal criteria (i.e. the Bar) for scientific rigor, patient benefit, and value.

• Serve as a standing member of development and business boards, and as PD co-chair of development boards, as assigned, to provide strategic development review and advice, go/no-go recommendations, and guidance towards maximising drug development efficiency and acceptable phase 3 PTS (probability of technical success).

• Be an active member of the therapeutic area leadership team, contributing to the definition and execution of the therapeutic area strategy with an enterprise mindset.

Clinical Development Accountability

• Responsible and accountable for global clinical development. Lead the Global Development Leaders (GDLs), Medical Directors (MD)/Monitors (MM), and Clinical Scientists (CS) in their own organization or advise MDs and/or CSs in the Early Clinical Development organizations, to ensure excellence in clinical development.

• Manage, advise, and support GDLs and oversee clinical development in the assigned Disease Area, including design, implementation, monitoring, and reporting of clinical studies within the Late Stage Development organization.

• Advise, or delegate advice, to RED Project Team Leaders on Clinical Development Plans.

• Interface with key internal (e.g. governance and advisory committees, PD functional heads in regulatory, clinical operations, safety, biometrics, etc, partnering, commercial, global pharma strategy) and external stakeholders (regulatory agencies, KOLs, PAGs, etc.) to align on the path to value and the value proposition to be pursued by asset teams.

• Accountable for strategic oversight, management, and prioritization of molecule enabling activities.

Organization and Culture

• Serve as the late-stage sponsor for cross-functional Disease Area Communities within the Therapeutic Areas, cultivating organizational focus on patients, science, and people.

• Actively manage talent and career development within their team and, as required, advise on and support career development of talent and potential successors outside of their teams.

• Make decisions on proposed promotions within their teams/organizations with input from the Therapeutic Area Head (TAH) and peers.

• Ensure efficient resource utilization and budget management as applicable (e.g. travel budget). Accountable for PDC DA resourcing in collaboration with their team's managers. Determine resource needs and identify opportunities for team members flowing to work during excess capacity.

• With an enterprise-wide mindset, facilitate strategic alliances and resource allocation within and across TAs as appropriate.

Qualifications

• MD or MD/PhD with board certification/eligibility in a neurology specialty is strongly preferred.

• 10+ years of clinical development experience

• Proven leadership in the relevant disease area, which may be demonstrated by 5+ years in a clinical development leadership position within thebiopharmaceutical industry or strong academic track record including clinical/scientific research and publication

• Proven experience with global regulatory submissions (IND, BLA, NDA) and active participation in meetings with Health Authorities strongly preferred

• Proven experience in managing, leading and developing people, including mentoring, coaching, and fostering career growth. Direct management (at least 5 years) of multiple direct reports is preferred.

Technical/Functional Skills

• Excellent understanding of Phase I-IV drug development, with demonstrated expertise in Phase II/III within the assigned DA or Therapeutic Area.

• Experience in evaluating external innovation working with business development colleagues to determine clinical development pathways and transformational benefit to patients strongly preferred

• Strong understanding of molecular drivers, diagnostic methods, and the pathology of the Disease Area.

• Proven track record of managing global clinical development teams strongly preferred

• Proficiency in authoring and reviewing clinical documents, such as clinical protocols and IBs.

• Deep understanding of and demonstrated compliance with GCP requirements.

• Excellent written and verbal communication skills.

• Track record of scientific and clinical presentations at major medical conferences.

Leadership & Key Behaviors

• Ability to lead and inspire cross-functional teams, with strong strategic and analytical skills.

• Effectiveness in a global, cross-functional matrix organization.

• Ability to lead innovation and significant change.

• Ability to influence without authority

• Excellent strategic agility and ability to make sound decisions.

• Strong interpersonal, influencing, and negotiation skills.

• Commitment to developing others and managing talent.

• Strong enterprise mindset.

Travel Requirements

• Domestic and international travel is required (approximately 30%)

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