Senior Director, Medical Writing

Categories: Regulatory
POSITION SUMMARY:
 
Crinetics Pharmaceuticals is seeking an experienced and highly motivated professional to lead the Medical Writing group to support our clinical development programs (Phase 1, 2, 3) and planned future commercial launch. This individual will report to the Head of Regulatory Affairs and be integral to advancing the company’s effort to discover, develop, and commercialize small molecule therapeutics for rare endocrine disorders and endocrine-related-tumors.
 
This is a unique opportunity to work with a proven and well-funded drug discovery and development team in a small company environment in the heart of San Diego’s biotechnology community.
 
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:
 
These may include but are not limited to:
 
  • Provide medical, scientific, and technical expertise for the generation and execution of clinical and nonclinical regulatory documents, manuscripts, grants, and other publications for internal and external use, as required.
  • Ensure that processes and systems are in place to support the authoring, editing, review, and approval of documents including, but not limited to, nonclinical and clinical study reports, protocols, briefing documents, investigator brochures and other documents necessary for regulatory and business needs.
  • Facilitate the planning and coordination of writing activities across the development organization and be accountable for resource planning, the selection and management of independent consultants and vendors, and the execution of all projects requiring writing support.
  • Build the medical writing team and function at Crinetics. Collaborate with internal stakeholders to expand in house writing capability to support all phases of development.
  • Provide guidance and strategy for product teams and direction to senior management on strategies for creation of global documents and dossiers for all Crinetics’ drug development programs.
  • Write clinical protocols, clinical study reports, investigator’s brochures, annual reports, IND summary sections, IMPDs, and NDA summary sections and other regulatory documents as required.
  • Coordinate and manage review cycles to triage, incorporate, and resolve team comments, and lead discussion on document revision and finalization.
  • Write, review, and/or edit publications (manuscripts, abstracts, poster presentations, etc.) as required.
  • Assist in the development and maintenance of SOPs and writing tools, such as templates and style manuals.
  • Provide training on medical writing templates, QC Procedures, SOPs, and processes within the department and across departments.
  • Contribute to the development of electronic document systems and tools.
  • Provide quality control support to other document authors (review of various regulatory and medical communications documents).
  • Ensure writing meets scientific and literary standards and meets objectives.
  • Undertake research in the therapy area to allow effective writing.
  • Monitor, communicate and manage budgets for their functional area.
  • Set clear outcomes/deliverables for projects and own them, staying accountable to the company management team.
  • Develop relationships with external parties (e.g., CROs, consultants, QA and regulatory professionals) and stay current on industry trends and practices.
  • Set high standards on deliverables while managing risks and timelines.
 
ADDITIONAL FUNCTIONS AND RESPONSIBILITIES:
 
Other duties as assigned
 
EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES:
 
  • Minimum BS in biological sciences or related discipline (advanced life sciences degree preferred) with at least 15 years of Medical Writing experience in a biopharmaceutical company with a proven record of significant experience and accomplishments.
  • At least 10 years in a management role overseeing individuals in a high performing team environment.
  • Proven ability to understand and interpret nonclinical and clinical trial data; ability to summarize complex results and present them in a clear, concise, and scientifically accurate manner.
  • Prior IND/NDA/BLA submission experience including use of eCTD.
  • Thorough knowledge and understanding of US CFR requirements and GxP for investigational and commercial products. Familiar with EU and ex-US requirements for clinical trials applications and marketing authorizations.
  • Prior experience working at a small company with wide ranging related responsibilities is desired.
  • Prior experience managing third parties and external service providers (worldwide) and consultants is preferred.
  • Excellent writing skills as they relate to preparation of regulatory documents.
  • Excellent interpersonal skills with strong oral/written communication and presentation skills.
  • Excellent negotiation skills and a tactful approach that leads to high value on outcomes achieved.
  • Excellent problem-solving ability.
  • Leadership and management skills, and, demonstrated qualities in this area.
  • Demonstrated ability to work effectively on multiple projects in a dynamic, complex, and fast-paced team environment.
  • Demonstration of cross-functional understanding related to drug development.
  • Good judge of risks and a keen ability to analyze options and manage outcomes.
  • Well versed with the latest trends in the drug development industry.
 
TECHNICAL KNOWLEDGE REQUIRED:
 
Equipment: PC, scanners, voice mail and e-mail systems, and common office machines, or ability to be trained.
 
Software Knowledge:  Windows, MS Office (Outlook, Excel, PowerPoint) and expert MS Word skills, Adobe Acrobat, EndNote, or other citation software. Proficient working with electronic document management systems use (notably Veeva) with advanced (e.g., superuser) experience preferred.
 
EFFORT REQUIRED/ENVIRONMENTAL CONDITIONS:
 
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. 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.
 
TRAVEL:
 
Travel may be required up to 10% of your time
 
ABOUT CRINETICS:
 
Crinetics Pharmaceuticals Inc. (www.crinetics.com) is a rare endocrine and endocrine-related cancer therapeutics company.  Crinetics’ benefit package includes health insurance, stock options, 401k, ESPP, paid time off, and the company provides a dog-friendly work environment.