[Remote] SVP Clinical Development - Remote Position
Note: The job is a remote job and is open to candidates in USA. Puma Biotechnology Inc. is a company focused on developing innovative cancer therapies, and they are seeking a Senior Vice President of Clinical Development to lead their clinical programs. This role involves directing the clinical development strategy, managing teams, and ensuring compliance with regulatory standards while fostering relationships with key stakeholders.
Responsibilities
• Managing, building, and leading clinical development teams to execute and achieve functional responsibilities and program goals in compliance with GCP, ICH, and other global regulatory requirements
• Playing a key role in defining “go/no-go” decision points, timelines and resources in alignment with the research and development goals and objectives of the collective as well as individual indications
• Playing a critical role in defining and executing clinical development strategy in the context of financial and market environments, clearly articulating and developing opportunities and threats, and evaluating options and plans against anticipated commercial and scientific trends
• Managing and maintaining strong, effective relationships with key external stakeholders and partners (i.e. KOLs and investigators, global vendors, consultants, patient advocacy groups, and other external clinical trial participants) to ensure that the primary goals of the clinical development programs are met
• Leading medical monitoring activities including acting as primary point of contact for day-to-day medical guidance for clinical trial staff at study sites, as well as for regulatory, safety and clinical operations and other functions requiring clinical input
• Providing clinical and medical guidance while working closely on joint projects with the medical affairs team to include IST studies, Scientific Congress/Conference strategy and planning, Advisory Boards, development of educational goals for medical education, publications, Field Force training, review of medical information standard response letters, health economics analyses, and marketing/policy related projects
• Leading in the strategic clinical development plans and execute on same, including, for example managing or assisting with: Scientific literature review and summarization, Protocol development, Regulatory briefing document preparation and review, Investigator meeting preparation and presentations, Clinical study report input, Assistance with writing and preparation of abstracts, presentations, and manuscripts
• Working with the team to identify and evaluate scientific, business licensing, partnership, alliance and outsourcing opportunities
• Working with key scientific and business executives in preparing presentations to the Board of Directors and Advisory Committees
• Effectively communicating clinical information to both technical and non-technical audiences to enable them to create a compelling case for the company’s efforts with potential customers and the investment community
Skills
• 5-10 years related international clinical development experience with a mix of corporate and academic experience required
• Must have a solid understanding of oncology and/or hematology drug development and life-cycle management
• Full working knowledge of Good Clinical Practice guidelines
• Demonstrated familiarity with PhRMA (the Pharmaceutical Research and Manufactures of America) code of conduct and with regulatory guidelines as they pertain to Phase IV activities
• Experience in planning and execution of clinical trials and investigator sponsored trials
• Ability to understand, interpret and explain scientific research and publications, presentations, and dissemination of clinical research data
• Experience supervising technical and managerial staff over a wide range of accountabilities in development
• Experience as a member of a senior management team responsible for achieving corporate goals
• Excellent oral and written communication skills and interpersonal skills
• Strong leadership, team building, negotiation, and ability to execute
• Ability to manage multiple projects in a fast-paced environment
• Ability to cultivate and maintain relationships throughout the organization and with thought leaders around the world and to establish trust through the consistent demonstration of scientific expertise
• Willingness to travel within the US and internationally as required
• Advanced Life Science Degree (MD, MD/PhD, DO or equivalent) strongly preferred
• Board Certification in oncology preferred
• Experience in Oncology is strongly preferred
• Experience in Breast Cancer and/or Small Cell Lung Cancer preferred
Benefits
• Annual bonus target
• Robust benefits package
Company Overview
• At Puma Biotechnology, our focus is on bringing innovative therapies to patients to enhance cancer care. It was founded in 2010, and is headquartered in Los Angeles, California, USA, with a workforce of 201-500 employees. Its website is http://www.pumabiotechnology.com.
Apply Now
Apply Now
Responsibilities
• Managing, building, and leading clinical development teams to execute and achieve functional responsibilities and program goals in compliance with GCP, ICH, and other global regulatory requirements
• Playing a key role in defining “go/no-go” decision points, timelines and resources in alignment with the research and development goals and objectives of the collective as well as individual indications
• Playing a critical role in defining and executing clinical development strategy in the context of financial and market environments, clearly articulating and developing opportunities and threats, and evaluating options and plans against anticipated commercial and scientific trends
• Managing and maintaining strong, effective relationships with key external stakeholders and partners (i.e. KOLs and investigators, global vendors, consultants, patient advocacy groups, and other external clinical trial participants) to ensure that the primary goals of the clinical development programs are met
• Leading medical monitoring activities including acting as primary point of contact for day-to-day medical guidance for clinical trial staff at study sites, as well as for regulatory, safety and clinical operations and other functions requiring clinical input
• Providing clinical and medical guidance while working closely on joint projects with the medical affairs team to include IST studies, Scientific Congress/Conference strategy and planning, Advisory Boards, development of educational goals for medical education, publications, Field Force training, review of medical information standard response letters, health economics analyses, and marketing/policy related projects
• Leading in the strategic clinical development plans and execute on same, including, for example managing or assisting with: Scientific literature review and summarization, Protocol development, Regulatory briefing document preparation and review, Investigator meeting preparation and presentations, Clinical study report input, Assistance with writing and preparation of abstracts, presentations, and manuscripts
• Working with the team to identify and evaluate scientific, business licensing, partnership, alliance and outsourcing opportunities
• Working with key scientific and business executives in preparing presentations to the Board of Directors and Advisory Committees
• Effectively communicating clinical information to both technical and non-technical audiences to enable them to create a compelling case for the company’s efforts with potential customers and the investment community
Skills
• 5-10 years related international clinical development experience with a mix of corporate and academic experience required
• Must have a solid understanding of oncology and/or hematology drug development and life-cycle management
• Full working knowledge of Good Clinical Practice guidelines
• Demonstrated familiarity with PhRMA (the Pharmaceutical Research and Manufactures of America) code of conduct and with regulatory guidelines as they pertain to Phase IV activities
• Experience in planning and execution of clinical trials and investigator sponsored trials
• Ability to understand, interpret and explain scientific research and publications, presentations, and dissemination of clinical research data
• Experience supervising technical and managerial staff over a wide range of accountabilities in development
• Experience as a member of a senior management team responsible for achieving corporate goals
• Excellent oral and written communication skills and interpersonal skills
• Strong leadership, team building, negotiation, and ability to execute
• Ability to manage multiple projects in a fast-paced environment
• Ability to cultivate and maintain relationships throughout the organization and with thought leaders around the world and to establish trust through the consistent demonstration of scientific expertise
• Willingness to travel within the US and internationally as required
• Advanced Life Science Degree (MD, MD/PhD, DO or equivalent) strongly preferred
• Board Certification in oncology preferred
• Experience in Oncology is strongly preferred
• Experience in Breast Cancer and/or Small Cell Lung Cancer preferred
Benefits
• Annual bonus target
• Robust benefits package
Company Overview
• At Puma Biotechnology, our focus is on bringing innovative therapies to patients to enhance cancer care. It was founded in 2010, and is headquartered in Los Angeles, California, USA, with a workforce of 201-500 employees. Its website is http://www.pumabiotechnology.com.
Apply Now
Apply Now