Director/Senior Director, Clinical Science

Title:                                        Director/Senior Director, Clinical Science
Reports To:                         Vice President, Clinical Development - Oncology
Location: Redwood City, California
Classification:                  Exempt

Overview:   

The Director/Senior Director, Clinical Science will drive the design, planning, implementation and execution of clinical development plans and programs in accordance with company processes, guidelines, study protocols and regulations. This role will work on cross functional programs to provide clinical development strategy, clinical program oversight and clinical interactions with regulatory agencies on program specific activities.

Principle Responsibilities and Duties:

• Partner with cross-functional program team members and key R&D stakeholders to contribute to the clinical strategy and creation of clinical development plans for one or more candidate clinical drug products.
• Provide clinical support for clinical study conduct, including operational feasibility, data management, communication plans, safety and medical monitoring, preparation of meeting materials and study updates.
• Perform medical and safety/efficacy data reviews. Prepare and communicate clear overviews of trial results.
• Identify issues related to study conduct and/or subject safety. Provide preliminary assessments and recommendations and collaborate with the clinical team to develop solutions ensure resolution.
• Provide organizational support for data review committees including operationalizing the charter, preparing updates and data reviews, development of meeting materials and data reports and execution of meetings.
• Author protocols and contribute to authoring of clinical study reports, IBs, ICFs, training documents, and other clinical and regulatory documents
• Interact with internal and external stakeholders (study sites, vendors, KOLs, etc.) in support of program-level strategy as well as clinical trial objectives
• Act as recognized clinical expert for assigned programs.
• Lead development of abstracts, posters, and content for scientific meetings, conferences and publications.

Experience and Education:

• PhD degree in health science field, PharmD, MD or non-US equivalent, or other relevant advanced degree in a health science field. 
• Minimum 7+ years of experience for Director, 12+ years of experience for Senior Director at a pharmaceutical, CRO or biotechnology company as a clinical scientist or related role.
• Experience in oncology or oncology immunotherapy clinical trials preferred
• Early stage drug development experience required.

• Experience with data analysis and interpretation

• Thorough understanding of the drug development process
• Broad understanding of functional areas of drug development, including preclinical, regulatory, pharmacovigilance, drug supply, data sciences (data management, biostatistics, programming), and clinical operations (including site selection, study start-up, …