Senior Director, Medical Writing
IDEAYA Biosciences
2 months ago
On-site
South San Francisco, CA
Clinical Research and Development
Position: Senior Director, Medical Writing
Location: South San Francisco (onsite 4 days/week)
Reporting to: Senior Vice President, Medical Writing and Project Management
What you’ll do:
- Lead authoring strategy and oversee development of clinical and regulatory documents (e.g., INDs, NDAs, BLAs, MAAs, Protocols, IBs/DSURs, CSRs, Briefing Documents) per 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 openness and trust
- Oversee vendors, budgets, and resources for medical writing
- Lead a medical writing team to meet portfolio needs
Requirements:
- Advanced degree (PhD, PharmD, MD, or MS) in life sciences
- 10–12 years medical writing experience in biotech/pharmaceutical industry, including 5+ years supervising a medical writing team
- Proven leadership experience supporting INDs and at least one major regulatory submission in oncology
- Expertise authoring/overseeing 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 using innovative technologies to expedite document preparation (e.g., AI tools)
- Experience in small to mid-sized biotech or fast-growth environments with novel oncology modalities
Preferred/Plus:
- Staff development experience
Total rewards (as stated):
- Expected salary range: $245,000–$302,000
- Medical/dental/vision (100% company paid for employees; 90% for dependents), 401(k), ESPP, wellness programs
Application instruction (as stated):
- Email interest once to humanresources@ideayabio.com.
Location: South San Francisco (onsite 4 days/week)
Reporting to: Senior Vice President, Medical Writing and Project Management
What you’ll do:
- Lead authoring strategy and oversee development of clinical and regulatory documents (e.g., INDs, NDAs, BLAs, MAAs, Protocols, IBs/DSURs, CSRs, Briefing Documents) per 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 openness and trust
- Oversee vendors, budgets, and resources for medical writing
- Lead a medical writing team to meet portfolio needs
Requirements:
- Advanced degree (PhD, PharmD, MD, or MS) in life sciences
- 10–12 years medical writing experience in biotech/pharmaceutical industry, including 5+ years supervising a medical writing team
- Proven leadership experience supporting INDs and at least one major regulatory submission in oncology
- Expertise authoring/overseeing 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 using innovative technologies to expedite document preparation (e.g., AI tools)
- Experience in small to mid-sized biotech or fast-growth environments with novel oncology modalities
Preferred/Plus:
- Staff development experience
Total rewards (as stated):
- Expected salary range: $245,000–$302,000
- Medical/dental/vision (100% company paid for employees; 90% for dependents), 401(k), ESPP, wellness programs
Application instruction (as stated):
- Email interest once to humanresources@ideayabio.com.