Clinical Development Strategist
vor 8 Stunden
At Genentech, we advance science so that we all have more time with the people we love. We are a leading biotechnology company dedicated to delivering innovative medical solutions. Our Clinical Development organization is structured by therapeutic area and is responsible for developing and executing late-stage development clinical strategies and plans to deliver medically differentiated therapies that provide meaningful improvement to patients.
The OpportunityWe are seeking an experienced Lead Clinical Research Scientist to join our team in San Francisco, Boston, Welwyn, or Basel. As a key member of our Clinical Development team, you will be responsible for the clinical science aspects relative to the study team, Study Leadership Team (SLT) or project team. This includes contributing to the clinical science aspects of the Clinical Development Plan (CDP) strategy and clinical documentation, representing the CDP on appropriate sub-teams and forums, leading training of study site personnel, acting as a primary point-of-contact for questions and enquiries to the CDP at a study level, conducting ongoing medical/safety data reviews, and providing clinical science inputs into study reporting.
Key Responsibilities- Contribute to the development of clinical trial protocols, informed consent forms, and case report forms.
- Lead the clinical science aspects of study teams, including the development of clinical development plans and strategic documents.
- Represent the Clinical Development organization on external forums, including advisory boards and investigator meetings.
- Collaborate with cross-functional teams, including Study Leadership Teams, Global Development Teams, and vendors.
- You hold an Advanced Clinical/Science Degree (e.g., PhD, PharmD, MSN, MPH, etc.).
- You have 2+ years of clinical development industry experience in both early and late-stage R&D drug development.
- You have demonstrated knowledge of governing laws, regulations, guidelines, and Roche SOPs on global clinical trial execution, as well as some knowledge of medical aspects of Good Clinical Practice (GCP), International Conference on Harmonization (ICH), FDA, EMA, and other relevant guidelines and regulations.
- You have a demonstrated understanding of the multidisciplinary functions involved in drug development, including therapeutic area-relevant clinical trial experience or clear potential to assimilate with some support.
- You have demonstrated clinical/research experience and/or clinical trial experience within the metabolic/diabetes space.
- You have the ability to independently carry out the majority of study conduct responsibilities.
- You have the ability to effectively integrate and contribute to cross-functional study teams in order to support global study strategies.
Genentech is a leader in biotechnology, with a rich history of innovation and a commitment to improving lives through science. We are an equal opportunity employer and value diversity, equity, and inclusion in all aspects of our business.
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