Astellas Pharma Senior Medical Director in Northbrook, Illinois
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 Senior Medical Director opportunity in Northbrook, IL.
Position & 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
Essential Job Responsibilities:
- 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 functions.
- 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 approval.
- Leads APGD 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 Global Development Project Leader (GDPL)).
- 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 Global Project Development Leader).
- 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 needed.
- Responsible, in collaboration with Clinical Sciences, for developing, recommending, adhering to the clinical development budget.
- 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 profile.
- 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 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.
- 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 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.
- 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 clinician.
- 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 environment.
- Additional post doctoral training or additional qualifications such as PhD, PharmD, certificate in Pharmaceutical Medicine highly desirable
- Prior experience in leadership role in EU/US regulatory filing
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled Category Medical & Development