Description
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.
- 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.
- Responsible for planning, managing, and aligning medical writing activities and communication across multiple projects and development programs.
- 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.
Requirements
- Bachelor’s degree in life sciences.
- Minimum of 8-10 years of relevant experience in biotech/pharmaceutical industry with at least 5 years of direct medical writing experience.
- 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.
- Experience managing direct reports and/or contractors.
- 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.
Preferred Qualifications
- 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.
