Job Information
Sumitomo Pharma VP Clinical Development, Oncology in Topeka, Kansas
Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=3440496098&u=https%3A%2F%2Fwww.us.sumitomo-pharma.com%2F&a=https%3A%2F%2Fwww.us.sumitomo-pharma.com+) or follow us on LinkedIn (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=2504638834&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fsumitomo-pharma-america%2F&a=LinkedIn) .
Job Overview
We are seeking an experienced VP Clinical Development, Oncology to fulfill a critical and highly visible role to help shape the future of development at SMPA. This role is responsible for the successful strategic positioning and tactical advancement of the clinical programs, and liaises with Clinical (including Clinical Operations), Biometrics, Regulatory, Early Clinical Development, Pre-clinical research, Medical Affairs and Commercial functions. The VP Clinical Development, Oncology will be responsible for leading and designing clinical programs in Oncology at SMPA.
The ideal candidate will need deep expertise in Oncology with strong leadership skills, scientific rigor, and the ability to collaborate effectively with cross-functional teams. The VP Clinical Development, Oncology is expected to cultivate relationships with scientific leaders and serve as an outward-facing representative of the company to the scientific community. This role will report to the Chief Medical Officer- Oncology and will have functional responsibility for all clinical development activities in Oncology across all stages of development.
Job Duties and Responsibilities
Overview
Strategic Leadership: Lead the strategic and clinical direction of the cross-functional teams from preclinical experiments to the end of the product’s life cycle.
Clinical Trial Oversight: Develop and oversee clinical trial strategies, ensuring alignment with corporate objectives and regulatory requirements for SMPA and the future oncology initiatives.
Medical Expertise: Deep knowledge and expertise in Oncology, scientific rigor and understanding of the different cross functional teams to interact for the best outcomes for SMPA.
Team Management: Lead and coordinate cross-functional teams to drive collaboration, enhance productivity and achieve goals effectively.
Regulatory Engagement: Interface with regulatory authorities, including the FDA, EMA, and other global agencies, to secure trial approvals and navigate the regulatory landscape.
Data Analysis and Reporting: Oversee data interpretation, ensuring accurate and timely reporting to internal stakeholders, regulators, and the scientific community.
Strategic Leadership:
Provide medical vision and clinical leadership for the strategy and plan to advance SMPA’s current and future product portfolio
Develop and execute the overall clinical development strategy for Oncology, aligning with SMPA’s overall goals and regulatory requirements.
Lead the medical and scientific aspects of clinical trials, including protocol design, study endpoints, and data analysis.
Provide medical expertise to cross-functional teams, including regulatory, commercial, and clinical operations.
Provide day-to-day practical and overarching strategic guidance for Oncology clinical programs, ensuring that the design, implementation, and conduct of the clinical studies provide unambiguous data and information that allows for clear decision making and advancement of development efforts.
Clinical Trial Oversight:
Manage the full lifecycle of clinical trials, from feasibility assessment and site selection to data analysis and reporting.
Provide leadership to cross-functional teams to create scientifically rigorous and innovative trial protocols.
Oversee clinical trial execution, ensuring quality, patient safety, and compliance with GCP standards.
Develop and execute corporate clinical strategy for global development projects in Oncology
Monitor clinical trial progress, identify and mitigate risks, and make necessary adjustments to study protocols.
Medical Expertise:
Provide medical vision and clinical leadership for the strategy and plan to advance SMPA’s current and future product portfolio.
Collaborate with key opinion leaders and investigators to ensure optimal clinical trial design and execution.
Provide clinical and medical expertise across all stages of drug development, from preclinical transition to post-marketing.
Stay abreast of emerging clinical trends and scientific advancements within Oncology.
Interpret clinical data, evaluate safety and efficacy, and make informed decisions regarding study continuation or termination.
Maintain understanding of competitors and clinical development in relevant areas of Oncology by attending scientific meetings and tracking literature.
Team Management:
Lead and mentor a team of clinical development professionals, including clinical project managers, medical monitors, and data analysts.
Oversee, plan, and manage the budget for Oncology clinical development activities.
Partner with Translational Research, Regulatory Affairs, Clinical Operations, and Medical Affairs to ensure the clinical program aligns with broader business goals.
Provide leadership and clinical expertise to the overall development organization including the clinical development, clinical operations, biometrics, clinical pharmacology, and non-clinical teams.
Regulatory Interactions:
Prepare and present clinical data to regulatory agencies (FDA, EMA) during IND submissions, clinical study reports, and NDA/MAA filings.
Collaborate with regulatory affairs team to ensure compliance with regulatory requirements.
Key Core Competencies :
A proven, impact-focused, builder and leader of high performing teams. Lead, mentor and manage a high-performing clinical development team, fostering collaboration and innovation
Ability to develop and successfully execute strategies at an organizational level.
Ability to collaborate effectively and build relationships with key stakeholders.
Capacity to make strategic decisions that have potential long-term positive impact.
Impeccable integrity, dependability, and a keen sense of urgency to achieve results.
Ability to adapt and quickly pivot according to business needs.
Ability to influence at all levels of the organization is a must.
Ability to manage, develop, and motivate a diverse team.
Ability to analyze complex clinical data and present findings clearly.
Significant experience with global clinical trials and regulatory process.
Credibility within the global medical and scientific community. Ability to forge solid personal and professional relationships with key opinion leaders is desired.
Sophisticated scientific management skills and business judgment with an ability to evaluate alternatives, establish priorities and apply resources effectively.
Strategic thinker with a hands-on approach.
Strong interpersonal and communication skills.
Excellent written and oral communication skills
Education and Experience
Medical Degree (MD) required
Additional training or certifications in clinical research, drug development, or Medical Oncology is highly desirable.
Minimum of 15 years of clinical development experience.
Experience with proven leadership in leading teams and progressing therapies in oncology through clinical development stages.
Experience leading programs through regulatory pathways, including IND and NDA filings and experience in interacting with regulatory agencies.
Experience in both large and small to mid-sized biotech companies preferred.
Experience presenting to a wide variety of audiences including internal teams, Executive Leadership, Board of Directors, medical and scientific communities.
The base salary range for this role is $ 329,600 to $412,000. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes unlimited paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
Confidential Data : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.
Compliance :Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.
Mental/Physical Requirements : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.
Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) and Affirmative Action employer
Sumitomo Pharma America (SMPA) is committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
For more information about EEO and the Law, please visit the following pages:
Equal Employment Opportunity is THE LAW (https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf)
EEO is the Law Poster Supplement
Pay Transparency (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf)
Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=3440496098&u=https%3A%2F%2Fwww.us.sumitomo-pharma.com%2F&a=https%3A%2F%2Fwww.us.sumitomo-pharma.com+) or follow us on LinkedIn (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=2504638834&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fsumitomo-pharma-america%2F&a=LinkedIn) .
At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company’s cultural pillars.
Our Mission
To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people worldwide
Our Vision
For Longer and Healthier Lives, we unlock the future with cutting edge technology and ideas