Astellas Diversity Jobs

Job Information

Astellas Pharma VP Medical Science Oncology in Northbrook, Illinois

Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture. There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company. Astellas is announcing a Vice President, Medical Sciences opportunity in Northbrook, IL.

Summary:

Responsible for implementation of drug development programs, including strategic in-put in clinical development plans at local and global level and oversight of protocol review process. This physician plays a role in the design of clinical trials, data analysis including analysis of both safety and efficacy, and review of documents. The VP for Medical Sciences will ensure adequate resources for development programs by recruiting, hiring, training and supervising competent physicians and ancillary staff and appropriate management of financial resources. The VP for Medical Sciences must have a sound knowledge of drug development issues, experience with interacting with regulatory agencies including document submissions, and ability to lead a diverse team.

Essential Job Responsibilities:

  • Supervises medical directors/senior medical directors across multiple therapeutic areas for development and post-marketing support of Astellas products
  • Assigns staff to local and global project teams to support R&D and organizational initiatives/programs
  • Encourages training and development to ensure readiness and competence of staff for future program needs and compliance with GCP and Astellas SOP's
  • Plans resources and budgets to meet programmatic needs
  • Reviews development plans and provides input on protocols, briefing documents and regulatory documents associated with development and support of marketed products
  • Prioritizes projects/programs reflecting global strategic direction
  • Establishes and contributes to strategic direction and design of clinical development programs to achieve regulatory and business objectives in concert with standards of other functional areas
  • Reviews licensing and product acquisition opportunities
  • Reviews and authorizes travel requests, payment of invoices and reimbursement of business expenses for direct reports, consultants, and contractors
  • Chairs Protocol Review Committee (PRC) and oversees administrative functions of protocol review including review of amendments and administrative changes. *

Quantitative Dimensions:

Scope

  • Recruits, develops, and retains staff to support clinical development programs
  • Assures adequacy of studies to support proposed indications and overall clinical development plan for compounds in development
  • Effectively manages resources to ensure protocols, development programs meet timelines, budget and objectives
  • Ensures timely and effective review of protocols by Protocol Review Committee focusing on safety, efficacy, and adequacy for overall development plan
  • Reviews and critiques clinical development plans, regulatory documents and strategic positioning
  • Represents Astellas in interactions with regulatory agencies, professional organizations, business partners, and the media per scope of activities
  • Interacts with external consultants and internal customers to improve development plans, R&D processes
  • Maintains and expands knowledge of current issues in drug development and proactively plans for anticipated changes in R&D
  • Leads and participates in process improvement initiatives for Medical Sciences, R&D and Astellas organizations

Challenges

  • Applying a dynamic scientific/medical knowledge base to current drug development
  • Developing and maintaining an effective working knowledge of diverse areas of medicine and drug development
  • Managing multiple and complex programs in diverse therapeutic areas
  • Working in a varied and complex cultural environment
  • Appropriately managing budgets, resources to optimize outcomes

Supervisory Responsibility:

  • Senior medical directors/medical directors (approx 7-9)
  • Senior Clinical Development Administrator (1)
  • Executive assistants (approx 2)

Qualifications:

Required:

  • MD degree (required)
  • Board certified in specialty (highly desirable)
  • State Licensure to practice medicine (highly desirable)
  • Minimum 3-5 years clinical experience
  • Minimum 2 years laboratory or clinical research experience
  • Minimum 5 years experience in pharmaceutical industry
  • Minimum 5 years managerial experience
  • Strong working knowledge of US regulatory procedures and guidelines including GCP; ex-US regulatory experience/knowledge highly desirable
  • Effective leadership skills in a matrixed R&D environment
  • Able to work independently on all aspects of assigned projects
  • Excellent organizational skills
  • Effective written and oral communication skills

#LI-VB

Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled Category Clinical Development

DirectEmployers