Senior Director, Medical Writing

IDEAYAs Non-Solicitation Policy strictly prohibits agencies and recruiters from any contact and communication with IDEAYA employees managers and leaders to submit unsolicited candidate resumes and/or to solicit business partnerships. Submission of unsolicited candidate resumes by agencies or recruiters with or without a contract in place with IDEAYA Biosciences Inc. will not create any implied obligation. Failure to comply with this policy will result in disqualification from current and future business opportunities with IDEAYA Biosciences. All recruiting and talent agency decisions are strictly managed by the internal IDEAYA Human Resources function. All communication by external agencies and recruiters must be directed to We ask that you only email your interest once.

Job Summary

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 youre 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 .

Location: South San Francisco

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 or San Diego office and required to be onsite four days per week per our company policy.

Reporting to: Senior Vice President Medical Writing and Project Management

Job Description

What youll do:

• Lead authoring strategy and oversee the successful development ofclinical 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

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
• Staff development experience a plus.

All employees are expected to act with integrity and in full compliance with applicable laws regulations and IDEAYA policies including IDEAYAs 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

Total Rewards

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.

The expected salary range for the roleof Senior Director Medical Writing is $ $245000 - $302000. 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.

The Company complies with all laws respecting equal employment opportunities and does not discriminate against applicants with regard to any protected characteristic as defined by federal state and local law. This position requires you to work onsite in the office at the Companys facilities for training & meetings with work-from-home flexibility and the Company requires that all employees working in its facilities be fully vaccinated (except as required by applicable law). Therefore this position requires you to be fully vaccinated from COVID-19 subject to reasonable accommodations for medical or religious reasons and/or as otherwise required by applicable law. The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. The vaccine must have been FDA approved have emergency use authorization from the FDA or for persons fully vaccinated outside of the U.S. be listed for emergency use by the World Health Organization.

IDEAYA is an equal opportunity accordance with applicable law IDEAYA does not discriminate in hiring or otherwise in employment based on race color religion sex national origin age marital or veteran status disability sexual orientation or any other legally protected status. EOE/AA/Vets.

We are committed to providing reasonable accommodations to qualified individuals with disabilities. If you need assistance or an accommodation due to a disability please get in touch with us at