The Vice President, Clinical Development will be responsible for leading the clinical development activities for assigned clinical program(s) within a matrixed environment and provide subject matter expertise and direction to the development and operations of assigned clinical project(s).
Apply knowledge of clinical development and project management to guide the creation of an overall product development plan for assigned clinical asset/s
Establish clear project plans and budget/s, and lead and manage the day to day clinical development activities and resources to efficiently achieve critical clinical development milestones with focus on late stage clinical development
Work with clinical investigators, external medical advisors and subject matter experts to evaluate clinical trial designs/development options and institute path forward to ensure achievement of program objectives
Provide direct managerial oversight and execution of clinical trials
Identify and effectively leverage internal and external capabilities needed to advance clinical milestone activities.
Ensure proper oversight of medical monitoring activities for clinical trials and respond to investigator questions concerning clinical trial conduct
Interpret clinical trial data, and work with the project team/s and investigators to develop scientific conclusions from clinical trial data
Contribute to the writing review and editing of study-related documents including clinical trial protocols, clinical study reports, regulatory documents, presentations and manuscripts for assigned clinical programs
As senior medical/clinical lead directly contribute to the NDA submission pathway and support filing activities as needed.
Prepare and deliver program updates.
Establish collaborative and productive relationships with parent company, internal/external partners and relevant affiliates.
Build, empower and develop team and instill high performance standards.
Develop and manage yearly budget for the department and ensure appropriate alignment to agreed portfolio. Participate and represent area of expertise in the Company’s Mid-term Business Planning process.
Liaise effectively with parent company and other internal stakeholder groups/personnel to advance the Company’s R&D pipeline and promote a highly collaborative operating culture.
Perform other duties as assigned.
M.D. with thorough understanding of the oncology arena.
15 + years of industry experience in clinical drug or program development or equivalent academic experience in clinical trials, especially in phase 1, 2 and 3.
Demonstrated skills working within a matrixed environment.
Ability to work collaboratively with others within and external to the company.
Expert level expertise in the design and conduct of clinical trials and project management in relevant therapeutic areas.
Experience evaluating outcomes of clinical trials and basic knowledge of clinical trial outcome standards.
Ability to evaluate complex clinical development options and propose solutions.
Ability to apply productive program management expertise to drive milestone achievement.
Demonstrated track record of leading by example and leading others in problem solving and finding creative solutions based on sound judgment.
Demonstrated track record of interaction with Health Authorities and filing clinical of clinical documents (e.g. NDA) to Health Authorities.
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.
The base salary range for this role is $327,300 to $385,000 annually. 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.
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
EEO is the Law Poster Supplement