Medical Director, Medical Specialties (Development)
Company: Astellas
Location: Northbrook
Posted on: January 16, 2021
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Job Description:
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, Medical Specialties (Development) 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
publicly 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 Head, Medical Specialties
and Therapeutic Area 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 Medical
Specialities 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 Head, Medical Specialties or to the
Executive Medical Director within Medical Specialties.* 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.Required Qualifications:Required * 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 * Prior regenerative
medicine development experience* Training in ophthalmology*
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-NB
Equal Opportunity Employer Minorities/Women/Protected
Veterans/Disabled
Keywords: Astellas, Chicago , Medical Director, Medical Specialties (Development), Executive , Northbrook, Illinois
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