Senior Vice President, Early Phase Clinical Development & Clinical Operations

Role Summary

Senior Vice President of Early Phase Clinical Development & Clinical Operations to lead our Early Phase Clinical Development & Clinical Operations strategy and execution of programs. This role is responsible for setting strategy, providing medical direction, management, and review of clinical trials and product development of our early phase clinical programs. The ideal candidate will possess a deep understanding of and demonstrated track record of having successfully led early phase Oncology clinical drug development including translational science and operational excellence, while also having a solid understanding of all phases of clinical drug development.

Responsibilities

• Oversees all early oncology development program activities and is responsible for execution of programs and timelines. Specific tasks include oversight of the strategy and design of clinical development programs for ongoing and new drug candidates, clinical protocol development, medical monitoring of clinical trials (where needed), and analysis of study data and preparation of trial reports and related regulatory documents.
• The individual may also serve as Development Project Leader for specific assets as the department evolves and will interact with most functions to ensure the successful progress of projects and clinical trials.
• Applies disease knowledge to clinical research trial development. Drives and delivers protocol development for clinical studies in collaboration with Clinical Scientists, Clinical Operations, and in close partnership with cross-functional teams
• Works collaboratively with associated clinical functions to oversee and participate in drafting clinical scientific documents such as IND, IND amendments, Investigator Brochures, Annual Reports (DSUR), and other FDA/HA submissions
• Contributes to CSR preparation and finalization
• In association with clinical operations colleagues and clinical scientists, contributes to the development of CRFs and data review plans when needed
• Oversees the Monitoring and review of safety and efficacy data in ongoing studies
• Serves as the key decision maker for clinical questions associated with eligibility, AE management, etc. for clinical studies
• Participates in developing clinical abstracts, and/or presents data at scientific meetings, SIVs, and conducts protocol training where needed
• Develop and participate in advisory boards
• Keeps abreast of hematology/oncology treatments, drug mechanism of action, approaches to drug development and regulatory requirements
• Acts as a clinical representative in variety of cross-functional and executive teams
• Partners with colleagues from Research, Translational/Biomarker and other Preclinical teams to help guide advancement of drug candidates with meaningful safety and efficacy profiles
• Serves as clinical partner for Business Development
• Ability and willingness to perform in IDEAYA‚Äôs working-leader environment where all leaders are expected to demonstrate strategic leadership, role modeling our company values, demonstrating collaboration and teamwork, and rolling up your sleeves on day-to-day deliverables
• Must be highly analytical, and comfortable with formulating and delivering data-driven, fact-based analysis
• Must be resourceful, demonstrate an agile and lean mindset approach, creative problem solver who seeks out and is receptive to new ideas and approaches to solving challenges
• Must fit our IDEAYA culture and be a true team player ‚Äì authentic, humble, professional, and inspirational leadership skills that build a positive team spirit to galvanizes high performance
• Ability to adapt to changes in the work environment, industry, manages competing demands
• Outstanding written and verbal communication skills with the ability to effectively present to and engage with a wide range of audiences
• Strategic thinking with the ability to drive results in a fast-paced and dynamic environment

Qualifications

• Medical degree and medical oncology training required
• Minimum of 15 years of clinical drug development experience within biopharma industry experience required
• Minimum of 10 years of leadership experience required
• Thorough understanding of oncology clinical trial design, including first-in-human Phase 1 studies of small molecules required
• Experience and understanding of clinical trial data monitoring and all aspects of drug development required
• Knowledge of GCP and ICH guidelines required

Personal Strengths

• A proven self-starter and team player with strong interpersonal skills who establishes and nurtures highly effective relationships with colleagues and key stakeholders to support and advance project goals and objectives
• Critical thinker with a solutions-oriented mindset
• Self-motivated to work effectively in a dynamic environment
• Possess strong organizational skills and conflict resolution abilities
• Deep experience and knowledge in oncology clinical development

Education

• Not specified in this description