Global Clinical Pharmacology Lead
Company: Astellas Pharma Inc.
Location: Northbrook, Illinois (Remote work permitted from certain states)
About Astellas
At Astellas, we are driven to develop innovative therapies that bring value and hope to patients and their families. With operations in over 70 countries, our commitment to addressing unmet medical needs is at the core of our mission. To learn more about us, visit Astellas' website.
Purpose and Scope
The Global Clinical Pharmacology Lead is responsible for overseeing clinical pharmacology from first-in-human studies through to approval, including post-marketing activities. This role focuses on therapeutic optimization and individualization by applying advanced scientific principles and quantitative frameworks (e.g., MIDD) to evaluate exposure-response relationships.
Essential Job Responsibilities
Serve as a subject matter expert on cross-functional project teams from candidate nomination through approval and post-marketing.
Lead cross-functional sub-teams to achieve Clinical Pharmacology goals throughout the development phases.
Oversee clinical pharmacology aspects of clinical trials, including study design and interpretation of results.
Collaborate with various disciplines and mentor junior team members.
Author and review clinical protocols, analysis plans, study reports, and regulatory submissions.
Develop high-quality clinical pharmacology plans for global regulatory submissions, including INDs, IBs, NDAs, MAAs, and pediatric plans.
Present clinical pharmacology components of the global clinical development program at internal and external meetings, including discussions with health authorities.
Qualifications
Required:
PhD or PharmD with a fellowship in clinical pharmacology.
At least 7 years of post-graduate experience in the pharmaceutical industry.
Thorough knowledge of scientific standards and global regulatory requirements.
Strong understanding of early development, clinical methodologies, and clinical endpoints.
Excellent written and oral communication skills with the ability to convey complex technical information clearly.
Expert knowledge of clinical pharmacology and experience with clinical dose setting and PK/PD relationships.
Experience integrating modeling and simulation activities (e.g., population PK, exposure-response) to support clinical pharmacology plans.
Adaptability and curiosity to learn about new modalities and apply clinical pharmacology principles to novel therapeutics.
Confidence to present to and influence senior leaders.
Preferred:
Experience in biologics or novel modalities in oncology drug development across all phases.
Benefits
Medical, Dental, and Vision Insurance
Generous Paid Time Off, including Vacation, Sick time, and national holidays
401(k) match and annual company contributions
Company-paid life insurance
Annual Corporate Bonus and Quarterly Sales Incentives for eligible positions
Long Term Incentive Plan for eligible positions
Referral bonus program
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Karnataka :
Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Punjab :
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Delhi | India | New Delhi | PAN-India |Assam :
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Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Arkansas | Remote Australia |New South Wales :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Kyiv |Lima Region :
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Lyon | Paris |South Africa :
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