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Lead Medical Director, Product Development, CVRM
Lead Medical Director, Product Development, CVRMGenentech • Boston, MA, United States
Lead Medical Director, Product Development, CVRM

Lead Medical Director, Product Development, CVRM

Genentech • Boston, MA, United States
[job_card.30_days_ago]
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  • [job_card.full_time]
[job_card.job_description]

Lead Medical Director, Product Development, CVRM

We advance science so that we all have more time with the people we love. 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.

Responsibilities

  • Support the development and implementation of the Clinical Development Plan (CDP) for assigned molecules / indications; gather and analyze data necessary to create the CD plan and participate in the design, development and execution of clinical studies.
  • Act as a medical monitor for assigned studies.
  • Collaborate with a variety of internal and external partners and stakeholders, including business development, research, commercial and legal teams.
  • Provide clinical science input and guidance for early development / Phase I studies and review and provide late-stage input to Phase I & II protocols.
  • Take an active role with other Clinical Science Team (CST) members, regulatory and other internal partners in the completion and submission of regulatory filings and other regulatory documentation and provide clinical science information and input for regulatory submissions.
  • Help support the strategic and operational alignment of the CD plan with the relevant CD strategy, asset team priorities and goals; develop CD plan components such as analytics / data strategy, KOL development, publications strategy, etc.

Qualifications

Required

  • MD / MBBS; board‑certified training (or equivalent) in endocrinology and / or substantial cardiovascular / metabolic / diabetes research and clinical experience.
  • 4+ years of post‑grad relevant clinical / scientific research and / or clinical trial experience.
  • Significant experience with data analysis, interpretation, and clinical relevance and demonstrated experience in scientific writing (manuscripts, grants, protocols).
  • Outstanding communication skills in scientific presentation and short‑form communication of complex scientific topics.
  • Preferred

  • Knowledge of the pharma / biotech industry and multiple functions involved in drug development.
  • Experience with various clinical trial designs (accelerated approval, pivotal, breakthrough, etc.).
  • Ability to collaborate with team members to measure and monitor study progress against objectives and plans, proactively communicate issues and potential strategies to resolve them.
  • Strong interpersonal skills and influencing abilities, building and cultivating important relationships inside the organization and externally, influencing internal partners and stakeholders, thought leaders, national advocacy organizations, national standard‑setting bodies, and other relevant external parties.
  • This position is based onsite in Boston, MA. Relocation benefits are being offered for this position.

    The expected salary range for this position based on the primary location of Boston, MA is $213,000 – $396,000. 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.

    Benefits

    #rochepdcvrm25

    Genentech is an equal‑opportunity employer. We employ, promote, and otherwise treat all employees and applicants on the basis of merit, qualifications, and competence. Our 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.

    #J-18808-Ljbffr

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    Director Product Development • Boston, MA, United States

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