Director, Medical Writing

Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine and a robust preclinical and clinical development pipeline. We are driven by science with a patient-centric and team-oriented culture. Crinetics is known for its inclusive workplace culture. We are also a dog-friendly workplace. This is an exciting time to join Crinetics as we shape our organization into the world’s premier fully-integrated endocrine company from discovery to patients. Join our team as we transform the lives of others.

Position Summary

Reporting to the Senior Director, Medical Writing, the Director, Medical Writing will be responsible for overseeing and managing the scientific medical writing group on a day-to-day basis. The Director, Medical writing will work closely with the Senior Director to ensure the group is adequately resourced and supported to deliver high-quality documents to the program development teams. This individual will also independently contribute to program-based medical writing projects with responsibility for writing, review, and approval of clinical and regulatory documents (e.g., Clinical Protocols, Investigator Brochures, Clinical Study Reports, Regulatory Briefing Documents, and CTD summary and overview sections for INDs and NDAs). Qualified candidates will have experience managing medical writers and collaborating across functions for document development activities. This leader will exercise sound judgement to solve acute challenges while collaborating with the Senior Director to institute iterative improvements to department operations (eg, standard timelines, templates, metrics, SOPs).

Essential Job Functions And Responsibilities

These may include but are not limited to:

Provide day-to-day management, leadership, and support to the scientific medical writing group by exemplifying the medical writing role through actions and behaviors

Focus on immediate and short-term (<2 years) strategic planning horizon

Oversee/develop department policies and procedures to achieve department and corporate goals

Ensure adequate resources are in place to successfully complete medical writing projects

Proactively drive document writing, review, and approval processes through collaboration and best practices development

Provide structure, mentorship, and guidance to individual contributors tasked with new project experiences (e.g., IND, NDA, MAA

Write and oversee the writing of clinical protocols, clinical study reports, investigator’s brochures, annual reports, IND and NDA summary sections, and other regulatory submission documents, as requested

Contribute to the improvement of Medical Writing processes and systems

Participate in the headcount planning process and determine department needs to support ongoing projects/programs

Other duties as assigned

Required

Education and Experience:

• Bachelor’s degree.
• A minimum of 12 years regulatory medical writing experience in the biotech/pharmaceutical industry. (An equivalent combination of experience and education may be considered.)
• A minimum of 8 years of experience in a leadership role is required
• Experience with writing sections of INDs/BLAs/NDAs/MAAs and an understanding of CTD structure and granularity requirements
• Extensive experience with clinical protocols and clinical study reports, including assembly of ICH appendices
• Experience using an electronic document management system as the primary tool to complete document generation, writing, review, and approval
• Knowledge of regulations relevant to medical writing
• Ability to manage/work on multiple writing projects at once while balancing overlapping timelines
• Ability to write clear, scientifically accurate text at a level appropriate to the audience and the project with careful attention to detail
• Demonstrated ability to collaborate across multiple scientific and operational functions to achieve timely document completion
• Solid understanding of statistical analysis as it pertains to clinical trials
• Working knowledge of GCP, GLP, GMP, and ICH guidelines and related FDA/EMA guidance on submission elements and integrated summaries of safety and of efficacy
• Excellent written and verbal communication skills
• Strong project management skills with ability to manage multiple projects and execute in adherence to timelines
• Excellent standard of written English, and ability to communicate fluently and effectively in English, both in writing and verbally
• Ability to quickly learn disease state and therapeutic paradigm to fully support the team in a scientific writing capacity and manage content and messaging across the program
  
  

Preferred

• Advanced life sciences degree
  
  

Physical Demands And Work Environment

Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is typically low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities.

Laboratory Activities (if applicable): Biology and chemical laboratory environment experience needed. Environmental health and safety requirements also apply.

Travel

You may be required to travel for up to 5% of your time.

The Anticipated Base Salary Range: $176,000 - $220,000

In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.

The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience and education. Crinetics Pharmaceuticals is a multi-state employer, and this salary range may not reflect positions that work in other states. Your recruiter can share more about the specific salary range during the hiring process.

Equal Opportunity Employer

Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws.

Vaccination Requirement

Following extensive monitoring, research, consideration of business implications, and advice from internal and external experts, Crinetics requires that all employees and contractors be fully vaccinated and have received the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.