Vice President, Clinical Science

Company: Iovance Biotherapeutics
Location: San Carlos
Posted on: June 12, 2021

Job Description:

Overview

This VP, Clinical Science is responsible for generating clinical development strategies and plans, covering phases from preIND to registration and overseeing the Clinical Science team in the direction, planning, execution, and interpretation of clinical trials and data collection.

Specific Responsibilities:

• Fully accountable to lead and oversee the clinical development team in the design and execution of all clinical studies across the full clinical and preclinical portfolio
• Designs and manages clinical development projects and teams, including working cross-functionally with all disciplines necessary for successful drug/therapy development: pre-clinical, manufacturing, quality assurance, regulatory, medical affairs, medical writing, marketing, legal, biostatistics and data management, pharmacovigilance, clinical operations and program management
• Identifies, interacts and builds collaborative relationships with key opinion leaders and academic organizations to assure incorporation of latest methods and guidelines into clinical development plans
• Interacts closely with the pre-clinical team, to understand the scientific basis of targeted therapy, and to apply this knowledge to articulating therapeutic strategies
• Leads the Clinical Science team in Clinical Development Plan creation and maintenance for the covered projects and indications, with a clear vision for how to enable data driven decisions (prioritization, Go/NoGo) in the context of the portfolio
• Directs and oversees clinical development team during protocol implementation including supporting the creation and reviewing key documents, site identification and communication, attendance and presentation at investigators' meetings, correspondence with sites including IRBs and interaction with operations teams
• Is accountable for and ensures highest quality of monitoring of clinical trials by clinical leads, medical monitors and clinical scientists, including data review and querying (patient profiles, data listings, other clinical outputs) in collaboration with data management, and oversight of all aspects of trial conduct and safety, contact with investigators and site study staff
• Ensures optimal collaboration of Clinical Science team with Clinical Operations during all phases of clinical trial execution, including development and execution of enrolment strategies
• Reviews safety and efficacy data, leads the clinical science team team through analysis and interpret the study results, and makes recommendations as to appropriate next steps. Monitors and explores data from clinical trial portfolio in real-time and is able to summarize and present current status on short notice.
• Supports clinical science team in data analysis and assembly, including clinical study report writing, contributes to the preparation of abstracts, presentations, and manuscripts
• Interacts closely with Medical Affairs in support of ISTs and publication strategy and plan, ensures clinical science team delivers highest quality of clinical data and output as member of publication team
• Collaborates with commercial teams, through the communication of medical issues to the commercial group, and by helping to formulate medical opportunities for the marketing team
• Interacts closely with the Regulatory group and regulatory agencies, taking part in regulatory submissions, investigator brochure authorship and communication with US and international regulatory agencies
• Hires, retains and manages staff for the company's clinical organization and engages and inspires the teams through communication of strategic plans and vision

Education and Qualifications:

• Board Certified MD with 10+ years of industry experience
• Subspecialty training in oncology preferred
• Outstanding academic achievement and significant clinical trial experience preferred
• Effective oral and written communication skills and excellent interpersonal skills with demonstrated ability to work with a team
• Experience in leading clinical development programs within a research-driven pharmaceutical or biotech company.
• Track record of leading projects through successful clinical development, registration and launch.
• Demonstrated independence, initiative and the ability to work well in a fast-paced environment
• Strong analytical and organizational skills with the ability to manage multiple projects effectively and simplify large amounts of complex information to draw valid conclusions, present strategic options, and communicate recommendations.
• Experience managing resources and budgets
• Keen ability for creative problem solving in executing project objectives.
• Demonstrated people management and cross-functional collaboration skills by proven accomplishments on previous manager and (matrix) leadership roles.
• High degree of organizational awareness and understanding of change management.
• Proven leadership skills including managing, developing, and mentoring direct reports.
• Travel time is approximately 15% to 25% including visits to investigative sites, regulatory agencies, and attendance at major oncology meetings

Physical Requirements:

• Sit for an extended time in front of a computer

Keywords: Iovance Biotherapeutics, San Francisco , Vice President, Clinical Science, Other , San Carlos, California