Who We Are

 

Kinnate Biopharma Inc. is a clinical-stage precision oncology company focused on expanding on the promise of targeted therapies for those battling cancer.

 

The company is developing medicines for known oncogenic drivers where there are no approved targeted drugs and to overcome the limitations of marketed cancer therapies, such non-responsiveness or acquired and intrinsic resistance.

 

Kinnate has two lead clinical programs being studied in solid tumors with RAF, NRAS and FGFR-driven alterations, and is rapidly progressing a pipeline of additional small molecule drug candidates as part of the Kinnate Discovery Engine.

 

The company is driven by the urgency and knowledge that patients are waiting for new, effective cancer medicines.   Come join us to help improve lives.

 

For more information, visit www.kinnate.com and follow us on LinkedIn.

 

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.

 

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

 

 

 

NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

 

We offer a competitive total rewards package that provide our employees with the resources to pursue their goals, both at work and in their personal lives.   The salary reasonably expected to be paid for this role is $248,073 to $263,400.  The actual compensation and seniority level for this position will be determined based on relevant experience and qualifications.  This position is eligible for an annual cash bonus and equity awards.  Our employees are also eligible to receive other benefits including: 

 

·         Unlimited Paid Time Off

·         10 Company Paid Holidays - plus 2 annual paid “Refresher Days”

·         Wide variety of comprehensive health, dental, and vision packages – most with minimal to no out-of-pocket expenses for employees

·         Company contribution to 401k plan

·         Employee stock purchase program

·         Annual Massage Days

·         Free local gym memberships

·         Healthy Lifestyle Reimbursement Program

·         Home Office Reimbursement Program

 

 

 

Kinnate recognizes the importance of balance and flexibility in our work environment. Physical presence at the Kinnate worksites or physical presence in the field is an essential job function of this role which the company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the company culture.

 

Kinnate is proud to be responsible members of our communities. Subject to applicable law, we require all our employees to be fully vaccinated and boosted against the COVID-19 virus. Therefore, all applicants seeking a role located in the U.S. must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. 

 

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.