Senior Director, Medical Writing

IDEAYA Biosciences • South San Francisco, CA

2d • Hybrid

About The Position

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 www.ideayabio.com.

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. This role is responsible for delivering high-quality regulatory and clinical documents that support global development and registration strategies. You will partner closely with Clinical Development, Regulatory Affairs, Biometrics, and Clinical Operations to ensure scientifically rigorous, compliant, and timely documentation. The ideal candidate brings deep oncology expertise, including familiarity with complex trial designs, endpoints (e.g., ORR, PFS, OS), and evolving regulatory expectations. Level will be commensurate with experience. This position is based in our South San Francisco headquarter offices and required to be onsite four days per week per our company policy.

Requirements

• Advanced degree (PhD, PharmD, MD, or MS) in life sciences
• 10-12 years of medical writing experience, in 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 skills, including excellent written and effective communication skills with senior stakeholders which are essential in this collaborative work environment.
• Self-motivated, with initiative and the ability to take ownership of, and follow through on specific tasks, initiatives or programs.
• Ability to manage multiple priorities in a fast-paced environment
• All employees are expected to act with integrity and in full compliance with applicable laws, regulations, and IDEAYA policies, including IDEAYA’s Code of Conduct. Employees must demonstrate good judgement and ethical behavior in all business activities, maintain patient and product safety as a top priority, and report any suspected violations of law or Company policy through appropriate channels

Nice To Haves

• Staff development experience a plus.

Responsibilities

• 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

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree
• Number of Employees: 11-50 employees