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Medical Director Oncology

Employer
Astellas Pharma US, Inc.
Location
Northbrook, Illinois
Salary
Negotiable
Closing date
Apr 25, 2019

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Position
Medical Director
Category
Medical Oncology
Hours
Full Time
Education
MD, MD / PHD

Job Details

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 Medical Director Therapeutic Area opportunity in Northbrook, IL.

Position & Scope:

  • Accountable and responsible for development and implementation of a global medical development plan on an early to late-phase project.
  • Serves as global medical lead (GML) on early stage project or at the indication study level for a larger/complex/multi-indication program.
  • Responsible for designing and conducting a global medical program resulting in quality regulatory submissions.
  • Responsible for the medical interface with drug discovery, regulatory and commercial colleagues.
  • Provides medical leadership on the Global Project Team and may chair the Global Clinical Team meetings; collaborates with other project team members and study team(s) to ensure delivery and quality of clinical trials.
  • Supports other projects as required.

Essential Job Responsibilities:

  • Fulfills the role of Global Medical Lead (GML) and is a member of the APGD Core Team.
  • Responsible for design and recommendations in clinical development plan for their drug, after soliciting appropriate input and review from Medical and Clinical Operations colleagues as well as other contributing line functions (Regulatory Affairs, Statistics. Clinical Operations, Commercial).
  • Leads the medical team for assigned clinical trials to design, implement, conduct and interpret clinical studies to support decisions to advance or halt development of a new drug or to successful filing regulatory submissions.
  • Responsible for execution and delivery of the clinical development plan.
  • Acquires publically available knowledge of competitor products and clinical plans.
  • Negotiates milestones and ensures clinical development objectives are met.
  • Motivates global clinical team towards the common goal of submissions of approvable regulatory filings or next clinical milestone.
  • Attends important meetings with the FDA and, as needed, with regulatory agencies worldwide.
  • Contributes to Global Project Team meetings.
  • Responsible for keeping GDPL, other project physicians and VP Global Medical Science TA Head informed of clinical progress and any critical clinical issues and especially the emerging safety profile.
  • Contributes to clinical documents: protocols, IBs, study reports, statistical analysis plans, publications, CSR and clinical sections of regulatory submissions.
  • Responsible for clinical expert panel meetings and advisory boards to give input on clinical plans
  • Presents to senior management and external audiences on clinical aspects of compound development: including milestones, strategies, recent data.
  • Incorporates Health Economics Outcomes Research requirements into protocol design.

Quantitative Dimensions:

  • Collaborates with Medical Directors across TA and may have oversight of study physician contractors.
  • Budget: allocated to the Global Project Team budget.
  • Responsible for decisions and advice in scientific, clinical and/or technical areas that can impact development timelines/regulatory review periods/acceptance and create significant delay or additional costs.

Organizational Context:

  • Reports to the Vice President Global Medical Science TA Head or to the Executive Medical Director TA Head.
  • Matrixed relationship to colleagues on the Global Project Team, Clinical Operations, Statistics, Regulatory Affairs, Clinical Pharmacology and Medical Affairs.
  • Collaborates with the APGD Global Development Project Leaders in assuring the smooth function of the Global Project Team.

Qualification Requirements:

  • Medical Degree (MD) or Medically Qualified with post graduate qualification and specialization in appropriate therapeutic specialty preferred
  • Should have at least 3 years relevant experience in drug development at a biotech/pharmaceutical company or the equivalent experience at an academic clinical research (NCI, NIH, Academic Research groups etc
  • Significant and demonstrable working-knowledge of regulatory procedures and guidelines in all regions (global scope)
  • Proven track record in clinical study design, monitoring and execution and results analysis
  • Has demonstrated knowledge of designing, implementing and conducting clinical studies, to produce both timely and good quality data.
  • Proven record of working on teams and in a matrix environment.
  • Proven ability to get results in a matrix management environment.

Preferred

  • Additional post doctoral training or additional qualifications such as PhD, PharmD, certificate in Pharmaceutical Medicine.
  • Prior experience in leadership role in EU/US regulatory filing.
  • Experience in development and implementation of global clinical trials for the registration and support of NMEs worldwide.

#LI-VB

Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled

Company

With revenues exceeding $2Bn and approximately 2,000 employees, Astellas Pharma US drives development efforts that offer innovative treatment of unmet medical needs and advancement of good health globally. Astellas is committed to becoming a global category leader in focused areas by combining outstanding R&D and marketing capabilities. In the U.S., Astellas markets products in the areas of immunology, urology, anti-infectives, cardiovascular and dermatology. Our client’s primary products include the antifungal Mycamine, the vascular dilator Andenoscan, enlarged prostate treatment Flomax, and the organ transplant immunosuppressant Prograf. Astellas’ other products include overactive bladder treatment VESIcare and dermatological products Protopic and Amevive. Further expanding upon internal development efforts to enter the oncology space, in 2007 Astellas Pharma Inc acquired Agensys, a biotechnology company specializing in therapeutic antibody research and development. Agensys was founded by an experienced executive team, and renowned UCLA oncologists and cancer scientists to explore drug targets and therapeutic antibody development. By applying differential gene expression technology to human tissues Agensys has identified 30 proprietary targets in 14 cancer types. Astellas is committed to becoming one of the top ten, global pharmaceutical companies by 2015. Critical to this success will be our employees. As such, Astellas is equally committed to being the employer of choice within the pharma industry. Offering first class benefits, an outstanding work environment and challenging development opportunities at every turn, Astellas is a great company for top performers who want to make a difference and be recognized for their contributions.

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