Senior Director, Medical Writing

Job Summary
IDEAYA Biosciences 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 (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.

Location: South San Francisco

Position Summary
Senior Director, Medical Writing – Provide strategic and operational leadership across oncology programs spanning early‑ and late‑stage development. This role is responsible for delivering high‑quality regulatory and clinical documents that support global development and registration strategies.

Job Description
Responsibilities

Lead authoring strategy and oversee the development of clinical and regulatory documents (e.g., INDs, NDAs, BLAs, MAAs, protocols, IBs/DSURs, CSRs, briefing documents) in accordance with 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 fostering openness and trust.

Oversee vendors, budgets and resources for medical‑writing.

Lead a medical‑writing team to successfully meet 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 and team development with high attention to detail and quality focus.

Strong interpersonal and communication skills with senior stakeholders.

Self‑motivated, with initiative and ability to take ownership of projects.

Ability to manage multiple priorities in a fast‑paced environment.

Staff development experience a plus.

Total Rewards
The role offers a competitive total rewards package that reflects our pay‑for‑performance philosophy. In addition to base salary ($245,000‑$302,000), employees are eligible for merit‑based salary increases, company discretionary short‑term incentive plan participation, and company discretionary stock‑option awards. Our benefits include medical/dental/vision coverage (100% company paid for employees, 90% for dependents), 401(k), ESPP, and wellness programs.

Equal Opportunity Employer
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. This position requires employees to be fully vaccinated from COVID‑19, with reasonable accommodations for medical or religious reasons. We are committed to providing reasonable accommodations to qualified individuals with disabilities. For assistance or an accommodation, contact hr@ideayabio.com.

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