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 & Scope:
Accountable and responsible for development and implementation of global medical development plans for early phase project(s).
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, commercial, and other key functional teams.
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 key 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 and others).
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 program milestones and ensures clinical development objectives are met.
Motivates and inspires 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 line manager, GDPL, other project physicians, VP Medical Science, and 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 as appropriate.
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.
Reports to the Executive Medical Director Oncology TA.
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 to ensure productive functioning of the Global Project Team.
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 delivery.
Proven record of results through working on teams and in a matrix environment.
Additional post-doctoral training or additional qualifications such as PhD, PharmD, certificate in Pharmaceutical Medicine.
Prior experience in immuno-oncology drug development (e.g. bispecific antibodies) strongly preferred.
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.
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
401(k) match and annual company contribution
Company paid life insurance
Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
Long Term Incentive Plan for eligible positions
Referral bonus program
Category Therapeutic Area - Oncology, Development
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans