Executive Director, Medical Lead, Immuno-Oncology Clinical Development

Job Description
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 establishing and overseeing implementation of a global medical development plan on a large complex late-phase project or on a group of complex earlier phases projects.
• Responsible for people leadership of direct reporting Medical Leads including, supervising and coordinating their project activities.
• Influential as a disease area expert both internal and external to Astellas.
• Ensures a seamless transition from exploratory studies (phase 1-2) to phase 3 registrational studies.
• Responsible for designing and conducting a global medical program resulting in quality regulatory submissions.
• Responsible for the Medical Leadership through interface with research, regulatory authorities and the commercial organization
• Provides Medical Leadership on the Global Project Team and chairs the Global Medical Team meetings.
• Supports other projects as required.
• Business requirements may include the need to provide leadership to the TA and to Medical Leads on various projects.
• Position may require representing the company in negotiations on clinical studies with alliance partnerships, meetings with regulatory authorities and meetings with medical expert or industry groups.

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 publicly available 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 and adhering to the Clinical Development budget.
• Motivates and inspires global medical team towards the common goal of submitting approvable regulatory filings (in conjunction with Global Project Development Leader).
• Serves as the Medical Sciences representative at some or most meetings with regulatory agencies worldwide as needed to support product development.
• Informs VP Global Medical Science and TA Head of the regulatory activities and meetings and solicits participation of the VP Global Medical Science TA Head as needed for major regulatory authority interaction.
• Contributes to Global Project Team meetings.
• Responsible for keeping GDPL, other project physicians, VP Global Medical Science and 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 and 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 as appropriate.
• May have responsibility to manage or mentor specific therapeutic area/sub-group within the Global Medical Science function through successful recruitment and retention of a high performing team and individual contributors. May have responsibility to manage the development and deployment of resources, while ensuring optimal oversight and supervision to ensure technical, leadership and team membership skills are maintained. If not directly managing other medical directors, serves as a mentor and works with senior line management to provide feedback and input to career development of junior medical staff.

Quantitative Dimensions:

• Works with a number of Medical Directors across global sites and may have one or more Medical Directors, employees or study physician contractors, reporting directly into this position.
• 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 Sr. Vice President Global Medical Science-Oncology.
• Has direct or indirect supervisor responsibilities for other physicians assigned to the project(s).
• 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 of the Global Project Team.
• Accountable for integrating medical aspects of a project with the Asia Development colleagues and with colleagues running country specific registrational studies.

Requirements
Qualifications
Required

• Medical Degree (MD) or medically qualified with post graduate qualification and specialization in the appropriate specific therapeutic area/or one of the groups preferred.
• At least 7 years of drug development experience specifically in human drug development at a biotech/pharmaceutical company or the equivalent experience at an academic clinical research (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, conducting and reporting clinical studies, to produce both timely and high-quality data.
• Experience managing and leading.
• Proven ability to deliver results in a matrixed management environment.

Preferred

• At least 3 years managing Medical Scientists and/or Medical Leads
• Prior experience in Clinical Development of cellular-based therapies
• Prior experience in Medical Leadership of regulatory fillings globally

Benefits:

• Medical, Dental and Vision Insurance
• Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
• 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