Senior Director, Medical Writing
About the role
IDEAYA is a precision medicine oncology company dedicated to developing transformative therapies for cancer. The Senior Director, Medical Writing role involves leading the development of clinical and regulatory documents that support global development and registration strategies.
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)
- 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 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
- 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)
- 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
- Self-motivated, with initiative and the ability to take ownership of, and follow through on specific tasks, initiatives or programs
- Staff development experience a plus
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 experience supporting INDs and at least one major regulatory submission in oncology
- 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)
- 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
- Self-motivated, with initiative and the ability to take ownership of, and follow through on specific tasks, initiatives or programs
- Staff development experience a plus
Skills
- Strategic thinking
- Scientific rigor
- Strong leadership and team development
- High attention to detail and quality focus
- Strong interpersonal skills
- Self-motivation
Benefits
IDEAYA offers a competitive total rewards package that reflects our pay-for-performance philosophy. Employees are eligible for merit-based salary increases, company discretionary short-term incentive plan participation, and company discretionary stock option awards (based on board approval).
The benefits package includes:
- Medical/dental/vision coverage (100% company paid for employees and 90% company paid for dependents)
- 401k
- ESPP
- Wellness programs
Pay
The expected salary range for the role of Senior Director, Medical Writing is $245,000 - $302,000. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the office location where this open position is located, the final candidates’ experience within their profession, experience in the disease areas we are striving to make an impact in as a company, length of time within the industry, educational background, and performance during the interview process.
Schedule
This position is based in our South San Francisco headquarters and required to be onsite four days per week per our company policy.
Total Rewards
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).
The 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.