Medical Director/Sr. Medical Director, Immuno-Oncology
Company: Astellas Pharma
Posted on: March 20, 2023
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Director/Sr. Medical Director, Immuno-Oncology - #22-POS00055209 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:
- Accountable and responsible for development and implementation
of a global medical development plan on a large complex late-phase
project or on a group of complex earlier-phase projects.
- Serves as global medical lead (GML) on one or multiple Astellas
Pharma Global Development (APGD) Core teams including late stage
and complex projects.
- Responsible for designing and conducting a global medical
program resulting in quality regulatory submissions.
- Responsible for the medical interface with research through
regulatory authorities and the commercial organization.
- Provides medical leadership on the Global Project Team and
chairs the Global Clinical Team meetings.
- Supports to other projects as required.
- Accountable and responsible for design and final
recommendations in clinical development plan for their drug (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
- Leads the global medical team(s) to design, implement and
conduct multi-phase development studies globally to support filing
of successful regulatory submissions and supplemental filings post
- Leads APGD medical programs when required as part of post
- Accountable and responsible for execution and delivery of the
clinical development plan (in conjunction with Global Development
Project Leader (GDPL)).
- Acquires public knowledge of present and future competitor
products and how they impact the internal medical and commercial
- Negotiates milestones and ensures clinical development
objectives are met (in conjunction with Global Project Development
- Plans for resources required both within the Medical Sciences
organization and in conjunction with the Global Development Project
Lead (GDPL) and the Global Development Operations Lead (GDOL) to
accomplish the objectives in a timely and resource-efficient
fashion. This includes the number of employees and contractors
- Responsible, in collaboration with Clinical Sciences, for
developing, recommending, adhering to the clinical development
- Motivates global medical team towards the common goal of
submitting approvable regulatory filings (in conjunction with
Global Project Development Leader).
- Contributes to Global Project Team meetings.
- Responsible for keeping GDPL, other project physicians, VP
Global Medical Science TA Head informed of clinical progress and
any critical medical issues and especially the emerging safety
- Coordinates and authors protocol synopses, major protocol
amendments and communicates upcoming changes to the Vice President
Global Medical Science TA Head.
- Provides input and medical review of clinical documents,
including protocols, IBs, study reports, statistical analysis
plans, publications, CSR and clinical sections of regulatory
- May plan and convene clinical expert panel meetings and
advisory boards that provide input into drug development
- 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.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.
- Accountable for integrating medical aspects of the project with
the Asia Development colleagues and with colleagues running country
specific registrational studies. Location(s) Northbrook, IL
- Medical Degree (or Medically Qualified) with post graduate
qualification and specialization in the appropriate specific
therapeutic area/or one of the groups preferred
- Should have at least 5 years relevant experience in drug
development in a biotech/pharmaceutical company or equivalent
experience in an academic clinical research role (NCI, NIH,
Academic Research groups, etc)
- Proven record of being a successful medical leader and a study
- Experience managing drug development programs.
- Experience designing, implementing and conducting clinical
studies, to produce both timely and high-quality data.
- Proven ability to get results in a matrixed management
- Experience working in Oncology and Immuno-Oncology
- Additional post-doctoral training or additional qualifications
such as PhD, PharmD, certificate in Pharmaceutical Medicine highly
- Prior experience in leadership role in EU/US regulatory
- Medical, Dental and Vision Insurance
- Generous Paid Time Off options, including Vacation, Sick time,
plus national holidays including Heritage Days, and Summer and
- 401(k) match and annual company contribution
- Annual Corporate Bonus and Quarterly Sales Incentive for
- Long Term Incentive Plan for eligible positions
Keywords: Astellas Pharma, Chicago , Medical Director/Sr. Medical Director, Immuno-Oncology, Executive , Northbrook, Illinois
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