IDEAYA Biosciences (NASDAQ: IDYA) is a public, clinical-stage synthetic lethality-focused 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 Synthetic Lethality. IDEAYA has established strategic collaborations with Amgen and Pfizer supporting its pipeline programs, and also has wholly-owned or controlled clinical and preclinical programs. For more information, please see www.ideayabio.com
We are seeking a highly motivated, well-organized, and skilled Senior Medical Writer to lead cross-functional teams in content preparation for submission to regulatory authorities; partners closely with key stakeholders, applies critical thinking, scientific writing, data interpretation, and knowledge of regulatory content life cycle.
Position level will be commensurate with experience.
What you’ll do:
- Lead the preparation of clinical and regulatory documents (e.g. Protocols, Investigator Brochures, IND Reports, Briefing Documents) in accordance with applicable guidelines, IDEAYA standards/SOPs and content management principles
- Plan content in partnership with functional leads and create timelines for the production of assigned documents. Ensure proper planning and resourcing of documents across development programs, including work to be outsourced
- Responsible for organization, clarity, scientific standards, formatting and consistency of content within and across all documents for a product or within a clinical dossier
- Lead document adjudication meetings and resolve issues with cross-functional contributors.
- Manage the review and approval process, including liaising with development partners
- Serve as publishing point of contact
- Work effectively with cross-functional, geographically and culturally diverse teams and establish strong collaborative relationships by creating an atmosphere of openness and trust
- Bachelor’s degree in life sciences
- Successful candidates will have a minimum of 3 years of relevant experience in biotech/pharmaceutical industry
- Demonstrated ability to produce clear, high-quality writing in the English language AND demonstrated experience in the preparation of a broad range of complex clinical and regulatory documents and global submissions
- Experience with the planning, authoring, review, and approval of clinical and regulatory documents including, but not limited to protocols, clinical study reports, IND/NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions
- Strong project management and team facilitation skills to lead complex projects in a fast-paced matrix environment
- Ability to influence without authority and foster the productive exchange of ideas amongst colleagues
- Experience managing projects of increasing scope and complexity
- Understanding of the interdependencies of various contributing functions (e.g., clinical pharmacology, biomarkers, health outcomes).
- Demonstrated ability and willingness to adjust behaviors and priorities based on a changing environment and competing priorities
- Highly effective communication skills and the ability to present ideas and data clearly to a group, including key stakeholders at a senior level
- Familiarity with approaches to expedite document preparation such as review tools and automation
- Master’s or doctorate degree in life sciences; oncology experience strongly preferred
- Ability to quickly assess complex situations, apply scientific, operational, and submission development knowledge and implement effective solutions.
- High-level technical, statistical, and computer skills, and the ability to interpret complex clinical data.
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.
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.
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.California Job Applicant Privacy Notice