VP/SVP, Clinical Development - Santa Clara, United States - Bayside Solutions

Description

VP/SVP, Clinical Development

Direct Hire Fulltime Role

Salary Range: $300,000 - $400,000 per year

Location: Redwood City, CA - Hybrid Role

Job Summary:

Report directly to the chief medical officer and provide leadership, clinical development strategy, and oversight of clinical science deliverables for our clinical programs. Additionally, the VP/SVP Clinical Development will provide supervision and management to Medical Directors and Clinical Scientists.

Duties and Responsibilities:

• Responsible for the delivery of clinical strategy for the pipeline
• Standing member of the program governance body
• Responsible for protocols and investigator brochures for clinical-stage molecules
• Develop and manage infrastructure, processes, and budget for the Clinical Science Organization.
• Hire, develop, and oversee the work of direct and indirect reports within the Clinical Science Organization.
• Drive protocol development by leading and partnering with a cross-functional team, including Research, Biometrics, Clinical Operations, Development Diagnostics, and Regulatory.
• Represent clinical with external stakeholders, including investigators, key opinion leaders, and investors.
• Play a leadership role in the design and timely and high-quality implementation of Phase 1-4 clinical studies.
• Play a leadership role in global regulatory submission and registration.
• Partner with cross-functional groups to map out clinical and regulatory strategies
• Collaborate with clinical operations on investigator selection and engagement.
• Partner with the Research and Development Diagnostics groups to ensure alignment of diagnostics strategy, including patient selection and development of companion diagnostics.
• Oversee the review, analysis, and reporting of clinical data in collaboration with biometrics to enable internal decision-making and regulatory filings.
• Lead the preparation and execution of clinical presentations at scientific conferences.

Experience, Skills, and Education:

• MD (or non-US equivalent) or MD/PhD, US board certified.
• A minimum of 10-15 years of experience in the pharmaceutical/biotech industry or academia, preferably the majority in oncology drug development
• A minimum of 5-10 years of leadership and management experience
• Extensive experience in protocol design, implementation, and management of global phase 1-4 clinical trials
• Direct experience interfacing with regulatory agencies, strong working knowledge and understanding of regulatory requirements for drug development, and preferably approval in more than one key region (i.e., US, EU, Japan)
• Outstanding knowledge of industry issues and competitive landscape in oncology
• Anticipate future trends and have a broad perspective of the competitive landscape and regulatory implications on clinical development; able to effectively communicate visions of possibilities and probabilities to executive management and cross-functional teams.
• Excellent track record and reputation in the industry, well-networked influencer and engager who regularly leverages such relationships to extend research, development, and business opportunities
• Experience networking with key opinion leaders in oncology and, more specifically, RAS and mTOR signaling pathways highly preferred
• Outstanding leadership, collaboration, and teamwork in a cross-functional setting; comfortable with a hands-on leadership position
• Effective prioritization and decision-making
• Consistently drive for results by setting aggressive but achievable goals.
• Inspire and motivate others to the highest levels of performance and quality within the Clinical Science Organization and beyond
• Excellent verbal and written communication skills and collaborative interpersonal skills
• Travel required.

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