Astellas is seeking a passionate and driven Medical Director to oversee the design and delivery of clinical trials within late-phase or multiple early-phase Immuno-Oncology programs. This role involves leading clinical study teams, ensuring patient safety, and contributing to the strategic development and execution of clinical trials. The successful candidate will thrive in a dynamic environment, embrace new ideas, and make a tangible impact on patients' lives.

Practice Info

• This position is based in Northbrook, Illinois.

• Astellas offers a hybrid working solution, allowing time to connect with colleagues at the office with the flexibility to also work from home.

Responsibilities

• Oversee the design and delivery of trials within a given late phase program or multiple early-phase programs in the Immuno-Oncology group.

• Serve as Medical Monitor with responsibility for safety monitoring, ensuring patient safety on clinical study is maintained.

• Coordinate with the Safety Officer on the program for appropriate benefit-risk assessments, planning FIH study dose selection, and escalation path for early-phase programs.

• Manage the process of development of protocol and necessary regulatory documents.

• Accountable and responsible for development, implementation, and execution of clinical trials as part of a large complex late phase program or a group of earlier stage programs.

• Acquire public knowledge regarding therapeutic landscape, potential competitor products, and serve as clinical voice regarding potential impact on planned strategies.

• Create and maintain scientific/clinical networks and seek external opinion leaders as appropriate, serving as the clinical interface during advisory boards and investigator meetings.

• Serve as the clinical interface in regulatory authority interactions.

Compensation

• Salary Range: $249,200 - $356,000 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations).

• Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions.

• Long Term Incentive Plan for eligible positions.

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.

• Company fleet vehicle for eligible positions.

• Referral bonus program.

Requirements

• MD or MD/PhD with oncology fellowship complete.

• Board certified with patient treatment experience beyond fellowship preferred.

• Must have 5 years of pharmaceutical industry experience specifically in clinical trial design and execution in a bio-pharmaceutical development organization or a balance of experience at an academic institution and a pharmaceutical company.

• Proven record of designing clinical trials that can produce high quality data in a timely manner for decision making.

• Documented experience planning and managing clinical trials, serving as medical monitor, managing trial execution in coordination with clinical operations.

• Excellent verbal and written communication skills in English.

• Experience working in global teams and a global matrixed, remote working environment.

• Aware of cultural diversity and how to influence and manage in a multi-cultural organization.

• Highest level of scientific integrity and impeccable work ethics.

• Extensive experience in gastroesophageal or thoracic oncology or immuno-oncology in solid tumors (Preferred).

• Prior clinical research experience in an academic setting (Preferred).

• Experience in all phases of Clinical Development and interfaces with Drug Discovery through Marketing (Preferred).

• Direct experience leading global regulatory marketing authorization submissions and defense of those submissions (Preferred).