Senior Clinical Development Manager, Immunology

Vor 2 Tagen


Basel, Basel-Stadt, Schweiz Roche Vollzeit
Job Description:

The Position
We advance science to improve patient outcomes.

Genentech's Product Development Clinical Science organization is structured by therapeutic area and focuses on developing and executing late-stage development strategies to deliver innovative therapies. The Lead Clinical Scientist plays a critical role in the clinical science aspects of study teams, Study Leadership Teams, or project teams, contributing to the effective execution of the Clinical Development Plan for molecules/indications.

Main Responsibilities:
- Contribute to the clinical science aspects of the CDP strategy and documentation.
- Represent the CDP on relevant sub-teams and forums.
- Lead training for study site personnel and act as a primary point-of-contact for CDP-related inquiries.
- Conduct ongoing medical/safety data reviews and provide clinical science inputs into study reporting.

Interactions with external stakeholders, including investigators, Therapy Area Experts, and vendors, are also required. In addition, the Lead Clinical Scientist may participate in interactions with Health Authorities.

You will be responsible for developing outlines for internal/external clinical presentations and communications, presenting at meetings, and contributing to manuscripts for peer-reviewed journals.

Experience in trial design, protocol writing, constructing CRFs, and coordinating cross-functionally is essential. You must understand the integration of individual studies into the broader CDP context and align with the Clinical Science Team.

Required Skills and Qualifications:
  • ">
  • Advanced Degree: PhD, PharmD, Master's Degree, MPH etc.
  • Clinical Development Experience: 2+ years of late-stage (phase II/III) and/or early-stage (phase I/II) industry experience.
  • Governing Laws and Regulations: demonstrated knowledge of global clinical trial execution regulations, GCP, ICH, FDA, EMA, and other relevant guidelines.
  • Multidisciplinary Functions: understanding of the functions involved in drug development, including therapeutic area-relevant clinical trial experience or clear potential to assimilate.

Benefits:
  • ">
  • Competitive Salary: $141,000 - $262,000 based on location.
  • Annual Bonus: discretionary bonus based on individual and Company performance.
  • Global Grade: SE6.


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