Director/Senior Director of Regulatory Strategy

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.

Kinnate provides top class benefits including unlimited vacation time; highly subsidized health benefits with a wide variety of providers and options, non-contributory 401k, new hire and annual stock options awards; Employee Stock Purchase Plan at a discount to current market prices; flexible and remote work options; free gym memberships and Healthy Lifestyle reimbursement program; Home Office equipment allowance; and commuter benefits for certain locations.

Your Impact at Kinnate

Kinnate is seeking an experienced and highly motivated regulatory professional to support our clinical development programs and future commercial launches. As the Director/Senior Director of Regulatory Strategy (San Diego or San Francisco), you will be the Global Regulatory Affairs Strategic Leader on one or more global oncology programs, responsible for developing and implementing innovative regulatory strategies for assets that have the potential to address critical unmet needs for patients with cancer. You will provide proactive cross-functional leadership and direction, have an ambitious outlook and drive a sense of urgency, and ensure effective communications internally and with regulatory authorities and other external stakeholders. This position reports to the VP/Head of Regulatory Affairs and may have direct reports.

Kinnate operates under a hybrid model: The majority of your time you will have the option of working remotely, with 10-20% of time spent at either our San Diego and/or San Francisco office. This position can be based in either location.

Responsibilities

· Primary regulatory strategic advisor & team member for the product development team(s). Translates complex regulatory issues into actionable strategies

· Manages the preparation, review and approval of global regulatory submissions and associated documents, providing primary authoring and hands-on support as needed

· Develops trusted relationships with FDA and other key regulatory authorities. Leads meaningful Health Authority interactions, defining strategy and project managing execution to achieve optimal outcomes in line with corporate objectives and timelines

· Evaluates opportunities to accelerate development. Anticipates and mitigates regulatory risks impacting development programs, providing clear guidance and recommendations to teams and to management

· Develops strong relationships with a network of regulatory service providers located worldwide

· Proactively maintains knowledge of the regulatory environment impacting the company, including emerging industry trends and changing regulatory expectations

· Contributes to the strategic leadership and growth of the regulatory function, including developing processes and best practices commensurate with a rapidly growing company

· Provide guidance/tutoring and train staff members as necessary. Provide regular feedback and coaching for their professional development.

· Occasional travel (up to 25%)

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

· Minimum Bachelor’s degree in chemical or biological sciences or related discipline with at least 10 years of Regulatory Affairs experience in the biopharmaceutical industry with a proven record of significant regulatory accomplishments

· At least three years in a management /supervisory role overseeing individuals in a high performing team environment

· Detailed knowledge and understanding of US FDA regulatory regulations, guidance and procedures for investigational and commercial products; a good knowledge of requirements in EU, Japan, China and other key territories.

· Experience with both early and late-stage drug development

· Capable and competent in setting strategies as well as taking a hands-on approach to all regulatory activities

· A successful track record of preparing regulatory documents including new INDs, NDAs/BLAs, MAAs, CTAs, IMPDs, PIPs, amendments, safety reports, annual updates, and documents for other regulatory submissions

· Regulatory affairs degree or RAC certification or equivalent is preferred

· Prior experience working at a small company with wide ranging related responsibilities is an advantage.

· Prior experience managing third parties and external service providers (worldwide) and consultants is preferred.

· Excellent problem-solving ability.

· Good command of GXPs (eg, GMPs, GLPs and GCPs).

· Good judge of risks and a keen ability to analyze options and manage outcomes.

· Strong leadership and experience in working with multiple functional areas in a matrixed team environment required

· Familiar with eCTD, e-publishing systems for preparing regulatory submissions a plus

· Strong verbal and written communication skills; ability to clearly articulate regulatory viewpoints to a diverse audience

· Ability to thrive in a collaborative and fast-paced team environment

Kinnate is a science-driven company. We expect every employee to be vaccinated against the COVID19 virus, and we require that vaccination to work in the office.

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.

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.