Lead Medical Director, Product (Late Stage) Development, Immunology

Roche

1d•Onsite

About The Position

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. The Lead Medical Director leads or 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. You will be responsible to ensure strategic and operational alignment of the CDP with the relevant CD strategy, strategic and annual LCP; you will work with other CST members and relevant sub-teams to develop CDP components (e.g., analytics/data strategy, KOL development, publications strategy, etc.)

Requirements

Board Certified/Board Eligible (or its equivalent) MD (MBBS), MD(MBBS)/PhD physician
5+ years of post-grad relevant clinical/scientific research and/or clinical trial experience
At least 2 years of experience in biopharmaceutical clinical 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)
Outstanding 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: has built and cultivated important relationships both inside an organization and externally
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
Sound knowledge of the pharma/biotech industry, the multiple functions and roles involved in the drug development process.

Nice To Haves

Trained rheumatologist and/or have demonstrated training in a related field
Substantial autoimmune-specific research and clinical experience
Academic research experience
Scientific Thought Leadership: A distinguished record of lead authorship (first or senior author)
Demonstrated Funding Success: Success in securing competitive external research funding, including NIH grants (e.g., K-series, R01) or equivalent prestigious international funding bodies (e.g., MRC, ERC, CIHR).
Demonstrated experience as a clinical development lead
Proven ability to use sophisticated analytical thought, identify innovative approaches and act as a mentor.
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

Leads or makes major contributions to the development of the Clinical Development (CD) strategy and plan.
Responsible for effective and efficient execution for the assigned molecule(s)/indication(s).
Supports the development and implementation of the Clinical Development Plan (CDP) for assigned molecule(s)/indication(s).
Gathers and analyzes data and information necessary to create the CD plan.
Collaborates with a variety of internal/external partners & stakeholders, as well as multidisciplinary internal groups, including business development, research, commercial, legal, etc.
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.
Takes 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.
Ensures strategic and operational alignment of the CDP with the relevant CD strategy, strategic and annual LCP.
Works with other CST members and relevant sub-teams to develop CDP components (e.g., analytics/data strategy, KOL development, publications strategy, etc.)