Position Summary
IDEAYA is seeking a highly motivated, well‑organized, and skilled Senior Director, Medical Writing to provide strategic and operational leadership across oncology programs spanning early‑ and late‑stage development. The position is based in our South San Francisco headquarters and requires onsite presence four days per week. The role reports to the Senior Vice President, Medical Writing and Project Management.
What You’ll Do
- Lead authoring strategy and oversee the successful development of clinical and regulatory documents (e.g., INDs, NDAs, BLAs, MAAs, Protocols, IBs/DSURs, CSRs, Briefing Documents) in accordance with applicable global regulatory requirements.
- Translate complex oncology and biomarker‑driven data into clear, scientifically accurate, compliant, submission‑ready documentation.
- Plan and manage medical writing activities, timelines, and resources across multiple programs.
- Lead cross‑functional document reviews, resolve feedback, and drive documents to approval.
- Work effectively with cross‑functional teams by creating an atmosphere of openness and trust.
- Oversee vendors, budgets, and resources for medical writing.
- Lead a medical writing team to successfully meet the portfolio needs.
Requirements
- Advanced degree (PhD, PharmD, MD, or MS) in life sciences.
- 10‑12 years of medical writing experience in the biotech/pharmaceutical industry, including 5+ years in a leadership role supervising a medical writing team.
- Proven leadership experience supporting INDs and at least one major regulatory submission in oncology.
- Demonstrated expertise in authoring and overseeing a broad range of clinical and regulatory documents.
- Strong knowledge of global regulatory requirements (ICH, GCP, CTD/eCTD).
- Proven ability to manage complex projects and influence cross‑functional teams.
- Experience managing direct reports, contractors, and/or vendors.
- Excellent written and verbal communication skills.
- Experience with innovative technologies to expedite document preparation (e.g., artificial intelligence tools).
- Experience working in small to mid‑sized biotech or fast‑growth environments with novel oncology modalities.
- Advanced knowledge of scientific medical writing principles, tools, and practices in oncology.
- Strategic thinking, scientific rigor, strong leadership, team development, high attention to detail, and quality focus.
- Strong interpersonal skills and the ability to communicate effectively with senior stakeholders.
- Self‑motivated, initiative‑driven, and able to take ownership and follow through on specific tasks, initiatives, or programs.
- Ability to manage multiple priorities in a fast‑paced environment.
- Staff development experience a plus.
Benefits
- Competitive total rewards package including pay‑for‑performance philosophy, merit‑based salary increases, short‑term incentive plan participation, and discretionary stock option awards.
- Medical, dental, and vision coverage (100% company paid for employees and 90% company paid for dependents).
- 401(k) and Employee Stock Purchase Plan (ESPP).
- Wellness programs.
EEO Statement
IDEAYA is an equal opportunity employer. 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.
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.
IDESY/AA/Vets. We are committed to providing reasonable accommodations to qualified individuals with disabilities. If you need assistance or an accommodation due to a disability, please get in touch with us at
#J-18808-Ljbffr