Director of Medical and Regulatory Writing

Who We Are

We are a dedicated team of professionals who take our work very seriously, but not ourselves too seriously. We are driven to deliver new medicines to cancer patients who desperately need solutions. We are a collection of individuals with diverse backgrounds and personalities, yet all united by this purpose to ignite the precision medicine revolution by delivering targeted therapies for those battling cancers. We are motivated by a profound sense of urgency and passion to create medicines with life-saving potential. If you enjoy co-elevating your colleagues and want to be part of a team of like-minded individuals united by a relentless pursuit to end cancer, then Kinnate may be the home for you.

Your Impact at Kinnate

As the Director of Medical and Regulatory Writing (San Diego or San Francisco based), you will be responsible for the function, and will lead the creation of documents pertaining to clinical studies and regulatory interactions, including (but not limited to) protocols, IBs, ICFs, clinical study reports, CT.gov submissions, briefing documents, INDs/CTAs, summaries for marketing applications, and responses to queries from regulatory authorities. You will develop & own Kinnate corporate templates & writing processes, leveraging industry best practices. You will be responsible for managing vendors that provide medical / regulatory writing and regulatory operations services. This position reports to the VP of Regulatory Affairs and can be based in either our San Francisco or San Diego location.

Kinnate operates under a hybrid model: The majority of your time will be working remotely, with time spent at either our San Diego or San Francisco office. This position can be based in either location and we will consider a fully remote applicant.

Responsibilities

· Independently authors complex documents that are compliant with external regulatory guidance and relevant internal processes and standards. Demonstrates subject matter expertise.

· Analyzes, interprets, and distills data and other information to create documents.

· Manages all aspects of document development process and leads project teams through process. Develops and maintains project timelines.

· Collaborates with project teams and subject matter experts to ensure clear, factual, effective, and concise presentation of analyses and associated discussions in assigned documents.

· Understands the principles of scientific writing, writing with the audience in mind and conveying messages in a clear and concise manner.

· Identifies potential areas for process improvements and possible solutions

· Demonstrate disease state expertise and knowledge of current medical and/or regulatory issues related to the product

· Management and oversight of vendors providing writing and regulatory operations services.

· Occasional travel (up to 10%)

Listed responsibilities are an essential, but not exhaustive, list of the expected initial duties associated with the position. The role will evolve over time and changes to individual responsibilities may occur due to business needs.

The Right Stuff

· BS/BA +12 years; advanced degree preferred: MS/MA +10 years, PhD +7 years of experience in medical / regulatory writing or related field.

· In depth experience of authoring protocols, IBs, CSRs, BBs and other clinical/regulatory documents in support of both clinical trial applications and/or marketing application submissions (NDAs and MAAs).

· Proficiency with global regulatory guidance (especially ICH, FDA, and EMA) relevant to clinical and safety data and submissions. Knowledge of Common Technical Document content templates, electronic document management systems and information technology.

· High fluency in spoken and written English. Strong oral presentation skills, including ability to present and explain data analyses.

· Knowledge of how to use publicly available databases (e.g., PubMed, FDA and EMA sources and guidelines) for literature and information mining to support document content and how to cite such information appropriately.

· Able to interpret analyses of data supporting regulatory/clinical documents and to summarize in clearly written text with minimal guidance from team members.

· Track record of communicating complex information and analyses effectively in writing to a variety of scientific and nonscientific audiences.

· Prior experience with document management systems and collaboration software (including cloud-based systems) and co-authoring principles is preferred.

· American Medical Writing Association (AMWA) certification, with a specialty in Pharmaceutical Writing, or other writing certification is preferred.

· Experience preparing manuscripts for publication in peer-reviewed medical journals, as well as abstracts and posters or oral presentations for scientific congresses

· Experience training or managing staff, managing budgets and vendors is a plus

In December 2020, Kinnate Biopharma Inc. closed a $276M initial public offering and are listed on Nasdaq. Prior to that, we closed three significant venture capital financings, including our $98M Series C round in July and August 2020 and our $74.5M Series B round in December 2019. Kinnate has a passionate and seasoned Team, guided by industry leaders in precision medicine and drug discovery, developing a focused portfolio strategy, and leveraging unique team expertise. Our Research and Development team is based primarily in San Diego, California and a portion of our management team is based in San Francisco, California. We are a small but growing precision oncology company with a bright future.

EEO & Employment Eligibility

Kinnate Biopharma Inc. is committed to building a diverse, equitable, and inclusive company. We provide equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Kinnate Biopharma Inc. also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of applicable law.

Why the Position is Open: New position to support expansion of the company’s clinical and regulatory capabilities.

Recruitment & Staffing Agencies: Kinnate Biopharma Inc. does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Kinnate or its employees is strictly prohibited unless contacted directly by Kinnate’s internal HR Team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Kinnate, and Kinnate will not owe any referral or other fees with respect thereto.