Medical Director (Early Development)
South San Francisco, CA, USA
Posted on Friday, February 9, 2024
IDEAYA Biosciences (NASDAQ: IDYA) is a public, clinical-stage precision medicine oncology company committed to the discovery and development of targeted therapeutics for patient populations selected using DNA sequencing and other molecular diagnostics. Our approach integrates extensive capabilities in identifying and validating translational biomarkers with small molecule drug discovery to select patient populations most likely to benefit from the therapies we are developing. We are applying these capabilities across multiple classes of precision medicine, including direct targeting of oncogenic pathways and synthetic lethality – which represents an emerging class of precision medicine targets. We believe this diversified approach will enable us to deliver the right medicine to the right patient to drive a more robust clinical response. IDEAYA has an industry leading platform and pipeline in precision medicine / synthetic lethality. IDEAYA wholly-owns or controls its three most-advanced clinical programs. It has established strategic collaborations with GSK, Amgen, Pfizer and Gilead supporting certain clinical and preclinical pipeline programs.
When you're at IDEAYA, you will be in the midst of brilliant minds working on precision medicine therapies to help cancer patients. We are passionate and committed about being on the forefront of oncology medicine, which means we all have a high internal drive that is at the very core of every person at IDEAYA. We are inquisitive, ask deep questions, and are data-driven innovators who like to collaborate and use team work to move science forward. For more information, please see www.ideayabio.com.
The Medical Director is responsible for providing medical direction, management and review of clinical trials and product development. Specific tasks may include design of a clinical development program plans, as well as clinical protocol development, medical monitoring of clinical trials, and analysis of study data and preparation of trial reports and related regulatory documents. The individual may also serve as a Development Project Leader for a specific asset and will interact with most functions to ensure the successful progress of projects and clinical trials. This individual will have a solid understanding of all phases of clinical drug development, translational science, and operational excellence. Excellent written and effective verbal communication skills, ability to influence across functions and levels, and flexibility/adaptability to work in a fast-paced environment are essential.
What you'll do:
- Applies disease knowledge to clinical research trial development
- Drives protocol development for clinical studies in collaboration with Clinical Operations and other clinical subteam functions
- Drives preparation of clinical development plans in partnership with cross-functional team
- Works collaboratively with Regulatory Affairs; drafts clinical scientific documents such as IND, IND amendments, Investigator Brochures, Annual Reports (DSUR), and other FDA/HA submissions
- Contributes to CSR preparation and finalization
- Contributes to development of CRFs and data review plans
- Monitors, and reviews safety and efficacy data in ongoing studies
- Serves as primary clinical point of contact (eligibility questions, AE management…) for clinical trial sites
- Develops abstracts, and/or presents data at scientific meetings, SIVs, and conducts protocol training
- Develops and participates 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 teams, including early stage Research teams
- Serves as clinical partner to Business Development
- Medical degree required; hematology/oncology training and/or practice experience
- Experience in industry in early phase development preferred
- Thorough understanding of oncology clinical trial design, including first-in-human Phase 1 studies as well as mid and late stage trials
- Experience and understanding of clinical trial data monitoring and all aspects of drug development
- Knowledge of GCP and ICH guidelines
- A proven self-starter and team player with strong interpersonal skills who establishes & 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
The salary range is an estimate and may vary based on the Company’s compensation practices.
The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law. This position requires you to work onsite at the Company’s facilities, with partial work-from-home flexibility, and the Company requires that all employees working in its facilities be fully vaccinated (except as required by applicable law). Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for medical or religious reasons, and/or as otherwise required by applicable law. The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.
Along with our highly collaborative and inclusive environment, IDEAYA offers a comprehensive and competitive benefits package that includes (but is not limited to) medical/dental/vision coverage (100% company paid for employees and 90% company paid for dependents), retirement benefits, ESPP and wellness programs. All full-time employees will also be eligible for an annual bonus and equity refresh.
IDEAYA is an equal opportunity employer. In accordance with applicable law, IDEAYA does not discriminate in hiring or otherwise in employment based on race, color, religion, sex, national origin, age, marital or veteran status, disability, sexual orientation, or any other legally protected status. EOE/AA/Vets.