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About the Role
Roche’s Clinical Development organization is responsible for developing and executing late-stage clinical strategies. The Lead Medical Director will lead or make major contributions to the Clinical Development (CD) strategy and plan, ensuring effective and efficient execution for assigned molecule(s)/indication(s). This role involves supporting the development and implementation of the Clinical Development Plan (CDP), gathering and analyzing data, and collaborating with internal and external partners.
Responsibilities
- Support the development and implementation of the Clinical Development Plan (CDP) for assigned molecule(s)/indication(s).
- Gather and analyze data and information necessary to create the CD plan.
- Collaborate with internal/external partners & stakeholders, and multidisciplinary internal groups.
- Provide clinical science input & guidance for early development/Phase I studies.
- Review and provide late stage input to Phase I & II protocols.
- Take an active role with other CST members, regulatory and other internal partners/stakeholders in the completion and submission of regulatory filings and other regulatory documentation.
- Provide clinical science information and input for regulatory submissions and other regulatory processes.
- Ensure strategic and operational alignment of the CDP with the relevant CD strategy, strategic and annual LCP.
- Develop CDP components (e.g., analytics/data strategy, KOL development, publications strategy) with other CST members and relevant sub-teams.
Requirements
- Board Certified/Board Eligible (or its equivalent) MD (MBBS), MD(MBBS)/PhD physician in Oncology & Hematology.
- 5+ years of post-grad relevant clinical/scientific research and/or clinical trial experience.
- 3 or more years of experience in biopharmaceutical clinical development with experience in late stage drug development.
- 3+ years of medical monitoring experience within the life sciences space.
- 2+ years of experience engaging with clinical sites, PIs, KOLs etc.
- Solid understanding of Phase II – III drug development.
- Demonstrated ability to foster and promote a highly productive and inclusive team-based culture in fast-paced clinical and/or research settings.
- Significant experience working with the principles and techniques of data analysis, interpretation and clinical relevance.
- Demonstrated experience in scientific writing (e.g. manuscripts, grants, scientific protocols, health authority documents).
- Demonstrated communication skills in both long-form scientific presentation and short-form communication of complex scientific topics.
- Strong interpersonal skills: Outstanding interpersonal, verbal, and written communication and influencing skills.
- Ability to collaborate with relevant team members to measure and monitor study progress against objectives and plans, including any variances, and proactively communicate any issues, challenges and potential strategies to resolve.
- Demonstrated experience working with various clinical trial designs, including outcome trials.
- Sound knowledge of the pharma/biotech industry, the multiple functions and roles involved in the drug development process.
Skills
- Oncology & Hematology
- Clinical Development
- Late Stage Drug Development
- Medical Monitoring
- Clinical Trial Experience
- Data Analysis
- Scientific Writing
- Communication Skills
- Interpersonal Skills
- Influencing Skills
- Collaboration
- Clinical Trial Designs
Location
- Boston, MA (US)
- San Francisco, CA (US)
- Basel, CH
- Welwyn, UK
Work Type
- On-site
Experience Level
- 5+ years of post-grad relevant clinical/scientific research and/or clinical trial experience
- 3 or more years of experience in biopharmaceutical clinical development with experience in late stage drug development
- 3+ years of medical monitoring experience
- 2+ years of experience engaging with clinical sites, PIs, KOLs etc.
Education Level
- Board Certified/Board Eligible (or its equivalent) MD (MBBS), MD(MBBS)/PhD physician
Salary/Compensations
- $213,000 - $396,000
Benefits
- Discretionary annual bonus may be available based on individual and Company performance.
- Benefits detailed at the link provided below.
About the Company
- Roche’s Clinical Development organization is structured by therapeutic area and is responsible for developing and executing the late development (Phase II – III) clinical strategies and plans that deliver medically-differentiated therapies that provide meaningful improvement to patients.
Equal Opportunity
- 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.
- If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.