Associate Director, Clinical Pharmacology and Exploratory Development Science - Medical

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:

• Provide science and strategic support to a set of clinical pharmacology studies and projects within a TA

• Provide for strategic Clinical Pharmacology (CP) and Exploratory Development direction and as a core team member leading a CP extended team for assigned projects from project kick off to commercialization.

• Provide for scientific and strategic recommendations and/or decisions important in successful drug development plans: a) innovative study designs, b) innovative data evaluation techniques, c) extrapolation of animal safety, pharmacodynamic and ADME data for dose selection in humans, d) innovative methods for assessment of exposure response relationship for PK parameters and efficacy and safety measures including bio-markers and e) can successfully interface and collaborate with scientific disciplines in non-clinical and clinical across Astellas Pharma Global Development.

Essential Job Responsibilities:

• Provide Clinical Pharmacology (CP) & Exploratory Development (ED) expert input to the development strategy of Astellas compounds with a global company perspective.

• Provide scientific leadership in design of clinical pharmacology studies and development of CSR

• Design and ensure delivery (through scientists and CP Ops) to core teams of creative, effective early clinical development strategies up to and including Proof of Concept and later on Clinical Pharmacology strategies leading to successful regulatory filings

• Provide clinical, (medical) scientific input to Translational Science Plans

• Be actively involved in Translational Science discussions

• Represent CPED on Core Project Teams.

• Knowledgeable of certain Disease Areas in order to ensure availability of state-of-the art knowledge and experience in Translational Science for practical application in clinical development.

• Provide clinical input to Safe First Dose document to guarantee the safety of first dosing to man.

• Be the Global Clinical Pharmacology Science Lead (with supervision) for in-house discovered or in- licensed compounds. This requires evaluating the input from a cross functional team of 15 -- 25 experts in toxicology, pharmacology, ADME, PK, MS, CP Ops.

• When required represent CPED in Due Diligence activities

• Maintain a current awareness of trends and developments in various expert fields of the department.

• Act in a global perspective with authorized responsibility in the fields of CPED disciplines.

• Publishes study results as appropriate.

• Responsible for having significant scientific input into the various sections of regulatory documents, such as IB, IMPD and CTD.

• May lead various working groups or initiatives to improve internal processes or best practices with the goal of improving CPED expertise and efficiencies

Quantitative Dimensions:

• Design at least 2-3 Exploratory Development or Clinical Pharmacology strategies per year.

• Contribute to on average 3-5 Translational Science Plans on projects.

• Provide (medical)/scientific contributions to 1-2 Safe First Dosing documents for compounds proposed to be entered first to humans.

• Contribute to on average at least 2-4 IB/IMPD/IND regulatory documentations.

• As a GCPL, provide the (medical) scientific lead for a cross-functional team of 15 - 25 people (e.g. scientists from PK, Translational Science, Toxicologist) in the design and delivery of Exploratory Development strategies to Proof of Concept or Clinical Pharmacology strategies through registration.

• Supervise at least 1-3 junior CPED scientists on the delivery of strategies

• Coach 1-2 new staff members on company and project team related procedures within APGD, US.

Organizational Context:

Reports to Senior Director or Executive Director, CPED Science

Qualifications:

Required

• Requires minimum 5 years post-graduate experience, in pharmaceutical industry, preferably from another (major) Pharma Company with a good understanding of Drug Discovery and Development.

• Preferred MD/ PhD /PharmD or MS with exceptional experience

• Expert knowledge of disease biology and relevant clinical disease knowledge required to design early development strategies up to and including PoC.

• Experience interacting with regulatory authorities and preparation of IND, IMPD, NDA, etc

• Expert technical knowledge of Clinical Pharmacology

• Operate with minimum of supervision within a project.

• Up to date with latest ICH-GCP guidelines and other relevant regulations.

• Highly developed sense for ethical conduct of Clinical Development

Preferred:

• Hands on quantative modeling experience

• Cell/Gene Therapy experience is a nice to have

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

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Category Clinical Pharmacology and Exploratory Development (CPED)

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans