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Senior Medical Director, Late Development
3 weeks ago
IDEAYA's Non-Solicitation Policy strictly prohibits agencies and recruiters from any contact and communication with IDEAYA employees, managers, and leaders to submit unsolicited candidate resumes and/or to solicit business partnerships. Submission of unsolicited candidate resumes by agencies or recruiters with or without a contract in place with IDEAYA Biosciences Inc. will not create any implied obligation. Failure to comply with this policy will result in disqualification from current and future business opportunities with IDEAYA Biosciences. All recruiting and talent agency decisions are strictly managed by the internal IDEAYA Human Resources function. All communication by external agencies and recruiters must be directed to We ask that you only email your interest once.
Job Summary
About IDEAYA Biosciences:IDEAYA is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer. Our approach integrates expertise in small-molecule drug discovery, structural biology and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers to develop tailored, potentially first-in-class targeted therapies aligned to the genetic drivers of disease. We have built a deep pipeline of product candidates focused on synthetic lethality and antibody-drug conjugates, or ADCs, for molecularly defined solid tumor indications. Our mission is to bring forth the next wave of precision oncology therapies that are more selective, more effective, and deeply personalized with the goal of altering the course of disease and improving clinical outcomes for patients with cancer.
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
Location: South San Francisco
Position Summary:
We are seeking a Senior Medical Director to join our Clinical Development team. The Senior Medical Director is responsible for providing medical direction, management and review of clinical trials and product development. Specific tasks may include design of 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 with particular expertise in late development, 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.
This position is based in our South San Francisco headquarter offices and required to be onsite four days per week per our company policy.
Reporting to: Senior Medical Director, Late Clinical Development
Job Description
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 sub-team functions
- Drives preparation of clinical development plans in partnership with cross-functional team
- Works collaboratively with Regulatory Affairs; drafts clinical scientific documents such as NDA,, 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 clinical abstracts, and/or presents data at scientific meetings, SIVs, and conducts protocol training
- Develops and participates in advisory boards
- Acts as a clinical representative in cross-functional teams,
- Serves as clinical partner to Business Development
Requirements:
- Medical degree required;
- Experience in Phase 3 trial conduct, design, and development preferred
- Thorough understanding of oncology clinical trial design, P1-P3.
- 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
Total Rewards
Along with our inspiring mission, and highly collaborative and inclusive environment, IDEAYA offers a competitive total rewards package that reflects our pay-for-performance philosophy where employees are eligible to be considered for merit-based salary increases, company discretionary short-term incentive plan participation, and company discretionary stock option awards (based on board approval). Our comprehensive benefits package includes, but is not limited to, medical/dental/vision coverage (100% company paid for employees and 90% company paid for dependents), 401k, ESPP, and wellness programs.
The expected salary range for the role of Senior Medical Director, Late Development is $306,000 - $378,000. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the office location where this open position is located, the final candidates' experience within their profession, experience in the disease areas we are striving to make an impact in as a company, length of time within the industry, educational background, and performance during the interview process.
The Company complies with all laws respecting equal employment opportunities 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 in the office at the Company's facilities for training & meetings, with 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.
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.
