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Astellas is announcing a Medical Director/Senior Medical Director, Oncology opportunity in our Deerfield, IL location.

The Senior Medical Director plays a leadership role in the strategic development and implementation of drug development programs for novel compounds from P0 through global approval. The Senior Medical Director may serve as global medical lead (GML) on Astellas Pharma Global Development (APGD) Core teams, or may support global development as an extended team member. The Senior Medical Director plays a key role in the design, conduct, analysis, and reporting of clinical trials including protocol development, evaluation of safety information from ongoing studies, data analysis and interpretation, and report writing. The Senior Medical Director may serve as medical expert in interactions with regulatory authorities. S/he will collaborate with the project team in developing the clinical strategy, preparation of key regulatory documents, and representing Astellas in meetings. The candidate must have significant pharmaceutical development experience; specific expertise in a oncology area is helpful. The candidate must demonstrate an ability to manage multiple projects, outside their therapeutic area if necessary, and to work independently on assigned projects. The candidate must demonstrate a track record of designing experiments/trials, analysis and interpretation of scientific data, and taking projects to completion. In addition to clinical trial implementation, the candidate will: organize and lead Advisory Boards; support and enhance professional relationships with investigators, consultants, and key opinion leaders; contribute to the evaluation of new products for licensing or acquisition; and provide medical and scientific input to internal teams regarding unmet medical needs, and input on mid-long term research strategies.

POSITION DUTIES:
Provides medical/scientific strategic input in clinical development program including target product profile, key go/no-go criteria, and risk management. In conjunction with study team, designs rigorous clinical protocols that address key strategic issues. Provides medical/scientific input in study objectives, selection of study populations, variables, data analysis, interpretation and completion of study reports. Facilitates meaningful interpretation and assessment of trial data, and decision making. Responsibilities may include programs at both early and late–stages of development.

Manages program and protocol risk based on target product profile, MOA, clinical pharmacology and preclinical data. Reviews and assesses safety data for subjects in clinical studies and from post-marketing reports.

Prepares and/or reviews updates to regulatory documents including Investigator’s Brochures, IND updates, PSUR’s, briefing documents, NDA’s, sNDA’s, and other regulatory documents. Provides medical/scientific expertise during regulatory interactions and negotiations.

Develops and maintains an up-to-date knowledge base for assigned project(s), including analysis of competitive drugs in development and marketed products. Knowledgeable about oncology specialty to ensure target product profile is appropriate from a medical/scientific perspective.

Facilitates communication and information sharing across project team, other functional areas in Astellas both locally and globally. As a global medical lead, leads the medical and safety management teams. Serves as liaison with medical consultants

Accountable for medical and scientific assessment of new chemical entities/licensed products for potential in-licensing and acquisition

Maintains an up-to-date knowledge of drug development regulations, good clinical practice guidelines (i.e., GCP, ICH), and compliance issues (eg: PhRMA guidelines).

May manage other employees in Medical Sciences.

Other related duties as assigned.
 

Position Requirements M.D. degree or equivalent; Board Certified or Board Eligible in oncology highly desirable
Minimum 6 or more years experience in the pharmaceutical industry or equivalent academic experience.
Strong working-knowledge of regulatory procedures and guidelines (preferably global)
Experience in P1-3 clinical development; prior EU/US regulatory filing experience expected.
Holds others accountable
Strong industry acumen, vision and perspective
 

 

Please visit our website at www.us.astellas.com to apply.