Jobs · Healthcare · California

Senior Director, Medical Writing

BioSpace · South San Francisco, CA · 2 days ago
Healthcare$245k–$302k/yrFull-time

About the role

IDEAYA is a precision medicine oncology company dedicated to developing transformative therapies for cancer. This role is based in South San Francisco and requires being onsite four days a week.

Responsibilities

  • Lead authoring strategy and oversee the development of clinical and regulatory documents (INDs, NDAs, etc.)
  • Manage timelines and resources for multiple programs
  • Collaborate with cross-functional teams to ensure scientifically rigorous, compliant, and timely documentation
  • 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 of medical writing experience, including 5+ years in leadership roles
  • Proven leadership experience supporting INDs and regulatory submissions in oncology
  • Expertise in global regulatory requirements (ICH, GCP, CTD/eCTD)
  • Strong project management and cross-functional team leadership skills
  • Experience with innovative technologies to expedite document preparation
  • Knowledge of scientific medical writing principles, tools, and practices in oncology
  • Strategic thinking, scientific rigor, strong leadership, and attention to detail

Qualifications

  • Advanced degree (PhD, PharmD, MD, or MS) in life sciences
  • 10-12 years of medical writing experience, including 5+ years in leadership roles
  • Proven leadership experience supporting INDs and regulatory submissions in oncology
  • Expertise in global regulatory requirements (ICH, GCP, CTD/eCTD)
  • Strong project management and cross-functional team leadership skills
  • Experience with innovative technologies to expedite document preparation
  • Knowledge of scientific medical writing principles, tools, and practices in oncology
  • Strategic thinking, scientific rigor, strong leadership, and attention to detail

Skills

  • Advanced degree (PhD, PharmD, MD, or MS) in life sciences
  • 10-12 years of medical writing experience, including 5+ years in leadership roles
  • Proven leadership experience supporting INDs and regulatory submissions in oncology
  • Expertise in global regulatory requirements (ICH, GCP, CTD/eCTD)
  • Strong project management and cross-functional team leadership skills
  • Experience with innovative technologies to expedite document preparation
  • Knowledge of scientific medical writing principles, tools, and practices in oncology
  • Strategic thinking, scientific rigor, strong leadership, and attention to detail

Benefits

  • Medical/dental/vision coverage (100% company paid for employees and 90% for dependents)
  • 401(k)
  • 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 including office location, experience, and performance during the interview process.

Schedule

This position is based in the South San Francisco headquarters and requires being onsite four days per week.

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