Instagram
youtube
Facebook

Clinical Scientist, Cvrm

1-2 years
Not Disclosed
10 Feb. 14, 2025
Job Description
Job Type: Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Clinical Scientist, CVRM
Location: South San Francisco, CA (USA), Boston, MA (USA), Basel (Switzerland), Welwyn (UK)
Category: Research & Development
Job Id: 202502-103718


Position Overview

Roche/Genentech’s Clinical Science organization is seeking a Clinical Scientist to contribute to the late-stage clinical development strategy for cardiovascular, renal, and metabolism (CVRM) therapies. In this role, you will work within cross-functional teams to support the Clinical Development Plan (CDP) for the molecule/indication, leading clinical studies, providing scientific inputs, and ensuring effective execution of clinical strategies.

Key Responsibilities

  • Clinical Development:
    • Lead or support clinical studies within the late-stage development phase (Phase II-III).
    • Contribute to the clinical science aspects of the Clinical Development Plan (CDP) strategy and documentation.
    • Act as a key point-of-contact for clinical science inquiries at the study level.
  • Study Leadership & Coordination:
    • Participate in study planning and protocol writing, including CRF development and training of study site personnel.
    • Collaborate with internal and external stakeholders, including investigators and therapy area experts (TAEs).
    • Support interactions with Health Authorities (HAs) under guidance from the Clinical Science Lead (CSL).
  • External Interaction:
    • Present clinical science findings at meetings such as investigator meetings, advisory boards, and scientific forums.
    • Contribute to regulatory submissions and scientific communication, such as abstracts, posters, and journal manuscripts.
  • Cross-Functional Collaboration:
    • Collaborate with multidisciplinary teams to ensure integration of individual studies into the broader CDP context.
    • Ensure clinical development strategies align across various functions.

Qualifications & Requirements

  • Education:

    • Advanced clinical or scientific degree (e.g., PhD, PharmD, MPH, or Master's degree).
  • Experience:

    • 1-2 years of experience in late-stage (Phase II/III) or early-stage (Phase I/II) clinical development.
    • Experience or knowledge of global clinical trial execution regulations (GCP, ICH, FDA, EMA).
  • Skills:

    • Strong knowledge of clinical trial design and protocol writing.
    • Ability to contribute to regulatory submissions and external interactions with Health Authorities.
    • Excellent interpersonal and communication skills, with the ability to influence and build relationships with key stakeholders.

Preferred Qualifications

  • Therapeutic Expertise:

    • Experience or potential in the endocrine, metabolism, or diabetes therapeutic area.
  • Study Conduct:

    • Ability to independently carry out study conduct responsibilities and contribute to study teams.
  • Cross-Functional Collaboration:

    • Proven ability to integrate and contribute to a global study strategy.

About Roche/Genentech

Genentech, a member of the Roche Group, has been a leader in the biotechnology industry for over 40 years, using human genetic information to develop groundbreaking therapies for cancer and other serious diseases. At Genentech, we prioritize diversity, equity, and inclusion to create a work environment where everyone can thrive and contribute to meaningful patient care.