Kura Oncology, Inc.
Director/Senior Director, Regulatory Affairs Advertising and Promotion Boston, M
Kura Oncology, Inc., San Diego, California, United States, 92154
Director/Senior Director, Regulatory Affairs Advertising and Promotion Boston, MA, San Diego, CA, or remote
The following information provides an overview of the skills, qualities, and qualifications needed for this role.Are you ready to join a team committed to making a meaningful impact on cancer treatment through the discovery and development of precision medicines? At Kura Oncology, you have an opportunity to be a part of something bigger, with a lasting impact that you can be proud of.At Kura Oncology, we are working to change the paradigm and improve the science of cancer treatment. As an organization, we strive to cultivate a diverse and talented professional culture driven to develop precision medicine therapeutics.As we continue to build a leading biotech organization with a strong culture, a patient-focused mindset and a team focused on relentless execution, we are looking for innovative, passionate professionals to join us and make our vision a reality.To succeed at Kura, you will need to have a demonstrated ability for excellence in drug discovery and development and a roll-up your sleeves attitude. The ideal candidate will possess a values-driven work style where integrity and grit drive all behaviors, decisions, and actions.JOB DESCRIPTION:The Director/Senior Director, Regulatory Affairs Advertising and Promotion will play a critical role in enabling the achievement of Kura business objectives by ensuring compliance with governing laws, regulations, and internal policies and procedures. This role will be responsible for review and approval of U.S. promotional and non-promotional materials and will serve as the primary liaison to FDA Office of Product and Drug Promotion (OPDP). This individual will provide commercial regulatory strategic and operational leadership to cross-functional teams.Reporting to the Head of Regulatory Affairs, this role will lead the development of processes and policies and establish commercial regulatory infrastructure in support of Kura’s evolution into a commercial organization. This role requires a deep understanding of industry regulations, excellent leadership skills and the ability to work cross functionally to drive regulatory strategies.ESSENTIAL JOB FUNCTIONS:Ensure U.S. advertising and promotional materials comply with applicable regulatory requirements, standards, and guidelines across all products.Serve as the Regulatory Reviewer and/or chair on promotional review committees and boards.Collaborate with colleagues in Commercial, Medical Affairs, Legal, and Compliance to incorporate regulatory considerations into promotional and non-promotional materials, including the creation of promotional and disease awareness communications, field training materials, and materials and communications used in scientific exchange.Provide creative guidance from a Regulatory perspective on the development of product messages and materials.Conduct risk assessments of U.S. promotional campaigns, providing guidance on potential regulatory risks and developing mitigation strategies.Serve as primary liaison for the FDA Office of Prescription Drug Promotion (OPDP) for assigned products and ensure timely and accurate submissions of promotional materials.Serve as an internal subject matter expert and provide strategic and operational commercial regulatory guidance to internal stakeholders on U.S. Advertising & Promotion issues including scientific exchange.Monitor new or revised legislation, regulations, guidance documents, industry standards, and enforcement actions related to promotional communications, disease awareness, and scientific exchange, and analyze and communicate their relevance to Kura.Drive continuous improvement initiatives within the regulatory affairs function, optimizing processes to enhance efficiency and effectiveness in managing advertising and promotional compliance.JOB SPECIFICATIONS:BS/BA degree; advanced degree desirable but not required.Minimum 10 years pharmaceutical/biotechnology industry experience, 5+ years in a U.S. advertising and promotion role.Advanced knowledge of U.S. advertising promotion regulations and scientific exchange provisions with proficient technical knowledge in aspects of drug development and labeling.Advanced experience with promotional and medical review supporting product communications, liaising with FDA (OPDP) on advertising and promotion matters, and managing regulatory submissions of promotional materials for marketed prescription drug products.Experience serving as the Regulatory Reviewer and/or chairing promotional review committees or other relevant regulatory governance committees.Experience with Veeva PromoMats a plus.Experience with product launches in the hematology/oncology and/or rare disease areas a plus.Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects and/or initiatives.Excellent written and verbal communication skills, with demonstrable proficiency in understanding and communicating scientific, medical and legal concepts and information.The base range for a Director, Regulatory Affairs is $212,000 - $245,000 and Senior Director, Regulatory Affairs is $260,000 - $295,000 per year. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location, and relevant education or training.Kura’s Values that are used for candidate selection and performance assessments:We work as one for patientsWe are goal-focused and deliver with excellenceWe are science-driven courageous innovatorsWe strive to bring out the best in each other and ourselvesThe Kura PackageCompetitive comp packageBonus401K + Employer contributionsGenerous stock optionsESPP Plan20 days of PTO to start18 Holidays (Including Summer & Winter Break)Generous Benefits Package with a variety of plans available with a substantial employer matchPaid Paternity/Maternity LeaveIn-Office Catered lunchesHome Office SetupLifestyle Spending StipendCommuter Stipend (Boston Office)Regular employee social activities, including happy hours, monthly birthday celebrations, Kura Koffee Talks, and much more!Kura Oncology is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.
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The following information provides an overview of the skills, qualities, and qualifications needed for this role.Are you ready to join a team committed to making a meaningful impact on cancer treatment through the discovery and development of precision medicines? At Kura Oncology, you have an opportunity to be a part of something bigger, with a lasting impact that you can be proud of.At Kura Oncology, we are working to change the paradigm and improve the science of cancer treatment. As an organization, we strive to cultivate a diverse and talented professional culture driven to develop precision medicine therapeutics.As we continue to build a leading biotech organization with a strong culture, a patient-focused mindset and a team focused on relentless execution, we are looking for innovative, passionate professionals to join us and make our vision a reality.To succeed at Kura, you will need to have a demonstrated ability for excellence in drug discovery and development and a roll-up your sleeves attitude. The ideal candidate will possess a values-driven work style where integrity and grit drive all behaviors, decisions, and actions.JOB DESCRIPTION:The Director/Senior Director, Regulatory Affairs Advertising and Promotion will play a critical role in enabling the achievement of Kura business objectives by ensuring compliance with governing laws, regulations, and internal policies and procedures. This role will be responsible for review and approval of U.S. promotional and non-promotional materials and will serve as the primary liaison to FDA Office of Product and Drug Promotion (OPDP). This individual will provide commercial regulatory strategic and operational leadership to cross-functional teams.Reporting to the Head of Regulatory Affairs, this role will lead the development of processes and policies and establish commercial regulatory infrastructure in support of Kura’s evolution into a commercial organization. This role requires a deep understanding of industry regulations, excellent leadership skills and the ability to work cross functionally to drive regulatory strategies.ESSENTIAL JOB FUNCTIONS:Ensure U.S. advertising and promotional materials comply with applicable regulatory requirements, standards, and guidelines across all products.Serve as the Regulatory Reviewer and/or chair on promotional review committees and boards.Collaborate with colleagues in Commercial, Medical Affairs, Legal, and Compliance to incorporate regulatory considerations into promotional and non-promotional materials, including the creation of promotional and disease awareness communications, field training materials, and materials and communications used in scientific exchange.Provide creative guidance from a Regulatory perspective on the development of product messages and materials.Conduct risk assessments of U.S. promotional campaigns, providing guidance on potential regulatory risks and developing mitigation strategies.Serve as primary liaison for the FDA Office of Prescription Drug Promotion (OPDP) for assigned products and ensure timely and accurate submissions of promotional materials.Serve as an internal subject matter expert and provide strategic and operational commercial regulatory guidance to internal stakeholders on U.S. Advertising & Promotion issues including scientific exchange.Monitor new or revised legislation, regulations, guidance documents, industry standards, and enforcement actions related to promotional communications, disease awareness, and scientific exchange, and analyze and communicate their relevance to Kura.Drive continuous improvement initiatives within the regulatory affairs function, optimizing processes to enhance efficiency and effectiveness in managing advertising and promotional compliance.JOB SPECIFICATIONS:BS/BA degree; advanced degree desirable but not required.Minimum 10 years pharmaceutical/biotechnology industry experience, 5+ years in a U.S. advertising and promotion role.Advanced knowledge of U.S. advertising promotion regulations and scientific exchange provisions with proficient technical knowledge in aspects of drug development and labeling.Advanced experience with promotional and medical review supporting product communications, liaising with FDA (OPDP) on advertising and promotion matters, and managing regulatory submissions of promotional materials for marketed prescription drug products.Experience serving as the Regulatory Reviewer and/or chairing promotional review committees or other relevant regulatory governance committees.Experience with Veeva PromoMats a plus.Experience with product launches in the hematology/oncology and/or rare disease areas a plus.Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects and/or initiatives.Excellent written and verbal communication skills, with demonstrable proficiency in understanding and communicating scientific, medical and legal concepts and information.The base range for a Director, Regulatory Affairs is $212,000 - $245,000 and Senior Director, Regulatory Affairs is $260,000 - $295,000 per year. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location, and relevant education or training.Kura’s Values that are used for candidate selection and performance assessments:We work as one for patientsWe are goal-focused and deliver with excellenceWe are science-driven courageous innovatorsWe strive to bring out the best in each other and ourselvesThe Kura PackageCompetitive comp packageBonus401K + Employer contributionsGenerous stock optionsESPP Plan20 days of PTO to start18 Holidays (Including Summer & Winter Break)Generous Benefits Package with a variety of plans available with a substantial employer matchPaid Paternity/Maternity LeaveIn-Office Catered lunchesHome Office SetupLifestyle Spending StipendCommuter Stipend (Boston Office)Regular employee social activities, including happy hours, monthly birthday celebrations, Kura Koffee Talks, and much more!Kura Oncology is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.
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