Senior Director, Medical Writing Job at BioSpace in south san francisco

Job Summary

IDEAYA is seeking a highly motivated, well-organized 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.

Location: South San Francisco. This position is based in our South San Francisco headquarters offices and is onsite four days per week per company policy. Reporting to: Senior Vice President, Medical Writing and Project Management.

What you’ll do

• 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, 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.
• Collaborate with cross-functional teams to foster openness and trust.
• Oversee vendors, budgets, and resources for medical writing.
• Lead a medical writing team to meet portfolio needs.

Qualifications

• 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 supporting INDs and at least one major regulatory submission in oncology.
• Expertise in authoring and overseeing a broad range of clinical and regulatory documents.
• Strong knowledge of global regulatory requirements (ICH, GCP, CTD/eCTD).
• 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 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, leadership, and high attention to detail and quality.
• Strong interpersonal skills and ability to communicate effectively with senior stakeholders.
• Self-motivated with initiative and ownership of tasks and programs.
• Ability to manage multiple priorities in a fast-paced environment.
• Staff development experience is a plus.

Total Rewards

IDEAYA offers a competitive total rewards package with merit-based salary increases, discretionary short-term incentive participation, and discretionary stock option awards (based on board approval). Benefits include medical/dental/vision coverage (100% company-paid for employees and 90% for dependents), 401k, ESPP, and wellness programs. The expected salary range for the role is $245,000 - $302,000. Final salary will depend on factors such as office location, experience, disease-area expertise, education, and interview performance.

The Company complies with all laws respecting equal employment opportunities and does not discriminate based on protected characteristics. EOE/AA/Vets. IDEAYA provides reasonable accommodations to qualified individuals with disabilities. For accommodations, please contact

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