The posting
Roche / Genentech maintains a robust presence across the Respiratory, Allergy and Infectious Diseases, discovering and distributing key treatments for conditions ranging from asthma and cystic fibrosis to viral infections. Our Clinical Development organization is structured by therapeutic area and is responsible for developing and executing the late development (Phase II – IIIA) clinical strategies and plans that deliver medically-differentiated therapies that provide meaningful improvement to patients. The Senior Group Medical Director leads and oversees multiple Clinical Science Teams (CSTs) who are responsible for developing global Clinical Development (CD) strategies and plans and ensuring effective and efficient execution for multiple molecules/indications. Senior Group Medical Directors are typically assigned large and complex portfolios.
We are seeking a Senior Group Medical Director & Global Disease Area Head (GDAH) for Respiratory, Allergy, and Infectious Diseases (AIR). As the senior-most expert within PDC, this leader holds ultimate accountability for the disease area's late-stage clinical development strategy and provides strategic leadership to the PDC Clinical Science team. The role drives end-to-end clinical strategies, guides portfolio asset development, leads business development efforts for the Disease Area (DA), and chairs relevant governance bodies. Serving as a key cross-functional partner, the GDAH collaborates closely with Roche Group Research and Early Development, Roche Diagnostics, Pharma Partnering, Technical Operations, and Global Pharma Strategy teams.
This is an on-site, hybrid position based in San Francisco, CA or Welwyn, UK.
Relocation benefits are available for this role.
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, accountable for the definition and execution of the global end-to-end DA strategy, collaborating with Roche Group Research and Early Development (RED) 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 RED, Roche Diagnostics, Medical Affairs, Commercial, Regulatory and Pharma Partnering senior leaders as well as health authorities, disease 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 and achievement 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 if assigned as PD co-chair of development boards 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 Immunology Therapeutic Area (TA) leadership team, contributing to the definition and execution of the TA 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 REDs, 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 (regulatory agencies, KOLs, PAGs, etc.) stakeholders to align on the path to value to be pursued by asset teams.
- Accountable for strategic oversight, management, and prioritization of molecule enabling activities.
- Oversee the end-to-end (E2E) drug delivery device strategy (where appropriate) for programs in your franchise and ensure each strategy is integrated within the overall clinical development plan and asset strategy for the assigned molecule to ensure seamless execution and regulatory alignment.
Organization and Culture
- Serve as the late-stage sponsor for cross-functional Disease Area Communities within the TA, 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 to flow 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 Respiratory, Allergy, or Infectious Diseases.
- 10+ years of clinical development experience
- Proven leadership in the relevant DA, which may be demonstrated by 5+ years in a clinical development leadership position within the biopharmaceutical industry and/or a 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
- Proven experience in managing, leading and developing people, including mentoring, coaching, and fostering career growth.
- Direct management (at least 3 years) of multiple direct reports is preferred.
- Ability to lead and inspire cross-functional teams, with strong strategic and analytical skills.
- You have the ability to travel approximately 30% of the time (domestic and international)
Technical/Functional Skills
- Excellent understanding of Phase I-IV drug development, with demonstrated expertise in Phase II/III within the assigned DA.
- 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 DA.
- 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.
- Track record of scientific publications and scientific and clinical presentations at major medical conferences.
Preferred:
- You have strong interpersonal skills: Outstanding interpersonal, verbal, and written communication and influencing skills: have built and cultivated important relationships both inside and outside of the organization and externally; have proven abilities to influence internal partners and stakeholders, thought leaders, national advocacy organizations, national standard-setting bodies, and other relevant external parties.
- You have a strong enterprise mindset; you are committed to developing others and managing talent. You have the ability to lead innovation and create change (where needed)
- You have experience working in a global, cross-functional matrix organization; you have strategic agility and the ability to make sound decisions
The expected salary range for this position based on the primary location of South San Francisco, CA is $340,000 - $631,800. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.
This position also qualifies for the benefits detailed at the link provided below. Benefits
Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
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