25 Oct
Astellas Pharma
Markham
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians.
If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world.
We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families.
Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world.
For more information on Astellas,
please visit our website at
www.astellas.com .
This position is based in Northbrook, Illinois.
Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines.
Candidates interested in remote work are encouraged to apply.
Purpose and Scope: The primary objective for the Medical Lead is to provide medical and strategic leadership into the planning, design, and conduct of clinical trials enabling successful development, registration, and access of an asset to patients.
Job Responsibilities: Accountable and responsible for design and final recommendations in clinical development plan for their investigational product (s), after soliciting appropriate input and review from colleagues within Regulatory Affairs, Commercial, and Medical Affairs (Global and Regional), Manufacturing, Clinical Pharmacology, Statistics, Health Economics and Outcomes Research and other line functions.
Leads the global development team(s) to design,
implement and conduct multi-phase development studies globally to support filing of successful regulatory submissions and supplemental filings post approval.
Leads CGTD medical programs when required as part of post marketing requirements.
Accountable and responsible for execution and delivery of the clinical development plan (in conjunction with Asset Lead.
Acquires public knowledge of present and future competitor products and how they impact the internal medical and commercial strategy.
Negotiates milestones and ensures clinical development objectives are met (in conjunction with Asset Lead).
Plans for resources required both within the CGTD organization and in conjunction with the Asset Lead and the Clinical Operations Lead (COL)
to accomplish the objectives in a timely and resource-efficient fashion.
This includes the number of employees and contractors needed.
Responsible, in collaboration with Clinical Operations, for developing, recommending, adhering to the clinical development budget.
Motivates global development team towards the common goal of submitting approvable regulatory filings (in conjunction with Asset Lead).
Responsible for keeping Asset Lead, other project physicians and scientists, and management informed of clinical progress and any critical medical issues and especially the emerging safety profile.
Coordinates and authors protocol synopses, major protocol amendments and communicates upcoming changes to the Medical Head of CGTD.
Provides input and medical review of clinical documents, including protocols, IBs, study reports, statistical analysis plans, publications, CSR and clinical sections of regulatory submissions.
May plan and convene clinical expert panel meetings and advisory boards that provide input into drug development plans.
Presents to senior management and external audiences' various medical aspects of drug development, including milestones, strategies, and recent data and anticipate obstacles to or changes to approved plans.
Incorporates Health Economics Outcomes Research requirements into protocol design.
Oversee medical monitoring strategy and escalate potential safety signals and concerns to the Medical Head.
Serve as a people manager to monitor employee's performance, offer feedback, and encourage them to reach their professional, corporate, divisional, and asset team goals.
Required Qualifications
Medical Degree (or Medically Qualified) with completion of residency in Ophthalmology, Neurology, Cardiology, Immunology or Internal Medicine/Pediatric Subspecialty with active or prior Board Certification
Willingness to work across different indications
Should have at least 8 years relevant experience in drug development in a biotech/pharmaceutical company or equivalent experience in an academic clinical research institute (NCI, NIH, Academic Research groups, etc) with at least 5 years working in clinical development
Proven record of being a successful medical leader and in study design.
Excellent writing skills with experiencing writing regulatory documents and attending Health Authority interactions
Experience managing drug development programs.
Experience designing and planning clinical studies, to produce both timely and high-quality data.
Proven ability to get results in a matrixed management environment.
Proficiency with ICH/GCP guidelines and other applicable regulatory rules and guidelines as well as of medical terminology, drug development, clinical trials, and clinical research.
Experience managing one or more direct reports
Preferred Qualifications
Experience working in at least one other therapeutic area outside trained subspecialty
Experience working in cell or gene therapy drug development
Benefits: Medical, Dental and Vision Insurance
Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
RRSP
Company paid life insurance
Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
Long Term Incentive Plan for eligible positions
Referral bonus program
#LI-TD
Category Cell and Gene Therapy Development
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans