Lead Medical Director, Product Development, CVRM

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.) This position will be based on-site in San Francisco, CA (US), Boston, MA (US), Welwyn (UK) or Basel (CH). Relocation support will be provided for this position. Who You Are: (Required) You are a Board Certified/Board Eligible (or its equivalent) MD (MBBS), MD(MBBS)/PhD physician in gastroenterology or hepatology and/or have significant clinical trial/development experience within these disease areas. (This position requires a strong understanding of Gastroenterology and/or Hepatology diseases.) You have 5+ years of post-grad relevant clinical/scientific research and/or clinical trial experience; You have 3 or more years of experience in biopharmaceutical clinical development with a significant level of experience in late stage drug development. You have 3+ years of medical monitoring experience within the life sciences space; you are able to support the senior team members with this responsibility. You have 2+ years of experience engaging with clinical sites, PIs, KOLs etc You have a solid understanding of Phase II – III drug development (e.g trials across different stages of development, or formal education/qualifications in pharmaceutical medicine or drug development); have made significant contributions to an organization’s drug development (whether at Roche or another organization); have identified and created clinical development strategies that have led to label-enabling outcomes You have demonstrated the ability to foster and promote a highly productive and inclusive team-based culture in fast-paced clinical and/or research settings You have significant experience working with the principles and techniques of data analysis, interpretation and clinical relevance, and demonstrated experience in scientific writing (e.g. manuscripts, grants, scientific protocols, health authority documents) You have demonstrated communication skills in both long-form scientific presentation and short-form communication of complex scientific topics

Requirements

Board Certified/Board Eligible (or its equivalent) MD (MBBS), MD(MBBS)/PhD physician in gastroenterology or hepatology and/or have significant clinical trial/development experience within these disease areas. (This position requires a strong understanding of Gastroenterology and/or Hepatology diseases.)
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 a significant level of experience in late stage drug development.
3+ years of medical monitoring experience within the life sciences space; you are able to support the senior team members with this responsibility.
2+ years of experience engaging with clinical sites, PIs, KOLs etc
Solid understanding of Phase II – III drug development (e.g trials across different stages of development, or formal education/qualifications in pharmaceutical medicine or drug development); have made significant contributions to an organization’s drug development (whether at Roche or another organization); have identified and created clinical development strategies that have led to label-enabling outcomes
Demonstrated the 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, and 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

Nice To Haves

Strong interpersonal skills: Outstanding interpersonal, verbal, and written communication and influencing skills: have 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, including outcome trials.
Sound knowledge of the pharma/biotech industry, the multiple functions and roles involved in the drug development process.

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.
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; 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.)