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
We are seeking an Executive Director and Head of Clinical Safety & Pharmacovigilance (PV) who will provide strategic leadership and oversight of the operational execution of a newly established Safety and Pharmacovigilance function.
Reporting to Kinnate’s Chief Medical Officer, the Head of Safety & PV will be responsible for ensuring the medical, scientific & operational excellence of Kinnate’s Pharmacovigilance practice within product development and be responsible for compliance with global safety regulations including legal accountability where called for.
You will be responsible for:
· Ensuring Kinnate’s practices proactive pharmacovigilance for all of its products,
· Ensuring appropriate procedures and resources enabling pharmacovigilance, risk assessment, risk communication and risk management,
· Ensuring global regulatory compliance
· Acting as a spokesperson & point of contact for external agencies and legal/regulatory bodies concerning Kinnate’s Pharmacovigilance and Risk management measures,
· Development, implementation & maintenance of Risk Management Programs,
· Recruitment, hiring, retention, and development of Safety staff,
· Leading change initiatives within the department and in interactions with other departments,
· Development and oversight of Safety budget
Key Responsibilities and Activities
Pharmacovigilance
• Oversee assessment, interpretation and management of potential safety signals.
• Oversight of product Risk Management Plans
• Review and approve PSURs, labeling changes and safety communications.
• Contribute to the development & maintenance of product safety profiles and quantification of risk/benefit profiles.
• Ensure the effective, centralized flow of patient safety information throughout global development
Governance
• Ensure the effective operation of product safety management teams & the Safety Management Teams / Company Safety Committee
• Participate in Kinnate’s product governance forums.
Issues Management
• Review and approve core data sheets and their amendments.
• Facilitate the Safety Management Teams & Company Safety Committee
• Support Corporate risk assessment and management on safety issues
• Oversight of Product Safety Reviews
Development support and liaison to other functions
• Support development of strategic plans for safety differentiation of Kinnate’s products
• Participate in regulatory interactions on product safety issues
• Ensure appropriate communication of safety data and interpretation internally and external parties
• Maintain and improve international collaboration on issues and processes
• Ensure coordination of Safety related interdepartmental processes/procedures
Internal Global Patient Safety Department Development
• Develop and support a global safety function at Kinnate with a singular voice on Global safety issues
• Direct the development and realization of the Safety department’s vision & long range plan
• Hire, manage, mentor, train and develop global safety staff
Qualifications, Experience and Competencies
· Relevant scientific/medical degree with a Higher/graduate degree (eg MD, PhD, PharmD) strongly preferred.
· Fifteen (15) years relevant clinical experience, including training
· Ten (10) years pharmaceutical/biotechnology industry experience
· Previous staff management experience and functional leadership
· Prior experience across pre- & post-market pharmacovigilance practice
· Direct experience of clinical trial development, execution, analysis & reporting
· Mastery of global regulatory requirements for pharmacovigilance
· Clinical knowledge of therapeutic area patient populations and drug class
· Clinical trial & Post-market safety analysis methods
· Exceptional Communication skills (written and oral presentations)
· Scientific and Group Leadership
We offer a competitive total rewards package that provides 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 $297,160 - $334,640. 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
11 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 is proud to be a responsible member 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.