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In light of recent advancements in the field of hematology, we are seeking a highly motivated physician with proven experience in hematology/oncology drug development to join our team. This role is an opportunity to contribute and develop hematology treatments in the non-malignant hematology space, specifically within hemophilia and gene therapy.
Roche/Genentech'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. The Lead Medical Director makes major contributions to development of the Clinical Development (CD) strategy and plan and is responsible for effective and efficient execution for the assigned molecule(s)/indication(s).
The Opportunity
1. You will support the development and implementation of the Clinical Development Plan (CDP) for assigned molecule(s)/indication(s); gathering and analyzing data and information necessary to create the CD plan.
2. You will collaborate with a variety of internal/external partners & stakeholders, as well as multidisciplinary internal groups, including business development, research, commercial, legal, etc and act as a subject matter expert and medical expert for trial related issues and events, health authority interactions, liaison with key opinion leaders in the area and provide publications support.
3. You will participate in meetings, reviews, discussions and other interactions regarding early development/Phase I studies to provide clinical science input & guidance; including reviewing and providing late-stage input to Phase I & II protocols. Within the franchise there is a seamless end-to-end model of collaboration with a very close liaison between early and late-stage functions.
4. You have a demonstrated experience of Phase II - III drug development.
5. You will 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. Provides clinical science information and input for regulatory submissions and other regulatory processes. Includes developing label and packaging language, etc.
6. You will be responsible to ensure strategic and operational alignment of the CD plan with the relevant CD strategy, strategic and annual LCP; you will work with other CST members and relevant sub-teams to develop CD plan components (e.g., analytics/data strategy, KOL development, publications strategy, etc.)
This position is based in South San Francisco, CA, Welwyn, UK and/or Basel, CH. Relocation benefits are not being offered for this position.
Who You Are:
(Required)
7. You have an MD, MBBS, or MD (MBBS)/PhD, 3+ years clinical experience; Board Certified training in Hematology/Oncology space
8. You have significant experience working with the principles and techniques of data analysis, interpretation and clinical relevance.
9. You have 4+ years of pharma/biotech late-stage clinical development experience.
Preferred:
10. Your experience will ideally encompass a strong backbone in non-malignant hematology, such as hemostasis and thrombosis and a good knowledge of the hemophilia / gene therapy drug development landscape.
11. You have a PhD with experience in basic research and a track record of publication in leading scientific journals
12. You have demonstrated experience as a clinical development lead; you have the proven ability to use sophisticated analytical thought, identify innovative approaches and act as a mentor.
13. You have demonstrated experience working with various clinical trial designs, (e.g. accelerated approval, pivotal, breakthrough etc)
14. You have sound knowledge of the pharma/biotech industry, the multiple functions and roles involved in the drug development process.
15. You can 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 such
16. You have strong interpersonal skills: Outstanding interpersonal, verbal, and written communication and influencing skills: has built and cultivated important relationships both inside an organization and externally. Has proven abilities to influence internal partners and stakeholders, thought leaders, national advocacy organizations, national standard-setting bodies, and other relevant external parties. Seamlessly collaborates with colleagues/other parts of the organization.
Relocation benefits are not being offered for this position.
The expected salary range for this position is $233,500 - $433,600 based on the location of South San Francisco, CA. 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.
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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