Lead Medical Director, Late Stage Development, Rheumatology

Genentech•Boston, MA

60d•Onsite

About The Position

Genentech is excited to be expanding its Late Stage Rheumatology team. Our 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). 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. You will collaborate with a variety of internal/external partners & stakeholders, as well as multidisciplinary internal groups, including business development, research, commercial, legal, etc. You may 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. You have a demonstrated understanding of Phase II - III drug development. 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. 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.) You may consult to pharma partnering on relevant acquisitions, joint ventures or other strategic partnerships, as these potentially relate to the assigned therapeutic/disease area(s)

Requirements

MD/MBBS, MD/PhD, 2+ years clinical experience; Board Certified Rheumatologist required
Significant experience working with the principles and techniques of data analysis, interpretation and clinical relevance.
4+ years of pharma/biotech late stage clinical development experience and/or is are recognized as a local expert in the field.
Significant experience designing and conducting clinical trials (i.e. one or more trials)
Demonstrated experience in late stage development; you have the proven ability to use sophisticated analytical thought, identify innovative approaches and act a mentor.

Nice To Haves

Experience publishing results of a scientific study in a peer-reviewed journal
Demonstrated experience working with various clinical trial designs, (e.g. accelerated approval, pivotal, breakthrough etc)
Sound knowledge of the pharma/biotech industry, the multiple functions and roles involved in the drug development process.
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 such
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.

Responsibilities

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.
Collaborate with a variety of internal/external partners & stakeholders, as well as multidisciplinary internal groups, including business development, research, commercial, legal, etc.
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.
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.
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.)
Consult to pharma partnering on relevant acquisitions, joint ventures or other strategic partnerships, as these potentially relate to the assigned therapeutic/disease area(s)

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