Director Clinical Development Immunology Gene Therapy

Profile

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 ****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.
The Role
The Director, Clinical Development - Immunology role is for a scientific expert in immunology that strategically supports the development and business objectives of several therapeutic areas across the product life cycle. This role will require an in depth understanding of immunology, cell biology, and translational biomarkers to support implementation and interpretation of clinical study outcomes. This role will collaborate closely with the Astellas Pharma Global Development cross functional team including Clinical Development, Clinical Science, Research, Regulatory Affairs, Biometrics, and Quality Assurance. The current focus of drug development at Astellas is in the development and commercialization of highly innovative gene therapy technology in diseases where there is unmet medical need and for children and adults with serious, rare genetic diseases. Importantly, the needs of the patient and family are uppermost in our minds as we progress our programs, and this philosophy is one that needs to be embodied in all colleagues at Astellas.
Primary Responsibilities:
Contribute to innovative and efficient study designs of gene therapy drug products and clinical development plans with clear data-driven decision rules.
Provide expertise and guide implementation of superior immunology-based assays for clinical studies and post-marketing needs.
Manage multiple immunology work streams and integrate results from a wide breadth of immune assays for gene therapy-based therapeutics.
Identify, recommend, help implement, and troubleshoot cell based and in vitro immunological assays for clinical trial sample testing of gene therapy-based therapeutics (i.e. T-cell response, anti-drug antibody).
Author and review internal documents pertaining to immunology related activities, sample analysis, and data analysis and interpretation.
Author and review relevant sections of clinical documents and publications pertaining to immunological assessment (e.g. Protocols, Reports, Investigator Brochures, manuals, and manuscripts) and documentation for submission to regulatory agencies (IND, BLA).
Develop and maintain relationships with corporate counterparts in Early Development, Research, Regulatory Affairs, Clinical Operations, Biostatistics, Medical Affairs, Commercial, and other groups to support nonclinical and clinical development programs.
Identify and highlight acceleration, innovation, and transformational opportunities where projects can offer highly significant benefit to patients.
Interface with and influence a range of scientific external experts (e.g. consultants, investigators, CROs, regulators) in order to deliver clinical programs that align to business strategy and address patient needs.
Serve as a scientific expert to medical affairs and commercial partners, as appropriate to support activities such as advisory boards, investigator meetings, and training initiatives including preparation and delivery of presentations.
Identify, gain access to, and develop professional relationships with targeted Key Opinion Leaders (KOLs), external partners such as clinical investigators, clinicians, scientists, and vendors in therapeutic areas of commercial and research interests.
Conducts review of published literature and clinical and preclinical reports in the field to provide the context for clinical development programs.
Maintain strong scientific knowledge and awareness of advances in the field of immunology as it related to gene therapy and neuromuscular diseases.
Requirements
Must Have/Required
A PhD degree in Immunology or related field with 12 years of clinical, scientific/research or industry related experience.
Relevant experience in clinical drug development (early stage development through approval) from initial study design, study execution and regulatory submissions (INDs, BLAs, NDAs) with US and OUS regulatory agencies.
Strong scientific background and experience in immunology and immune response assessments.
Knowledge of clinical trial methodology, regulatory and compliance requirements. governing clinical trials and experience in the design of study protocols is desirable.
A history of strong collaboration and personal interaction with all levels of internal stakeholders including, Regulatory Affairs, Medical Affairs, Clinical Operations, Biometrics, and Research.
Ability to understand and effectively communicate scientific, medical and regulatory information.
Strong leadership skills, with proven ability to inspire high performance from cross-functional teams.
Strong practical knowledge of method development, troubleshooting, and validation in accordance with regulatory and industry guidelines.
Comfortable working in a flexible and dynamically changing environment.
Excellent technical writing and communication skills; able to articulate complex scientific concepts to diverse functional groups and external stakeholders.
Proficient in data analysis software (SigmaPlot, GraphPad, etc.) and data presentation.
Ability to travel up to 10% domestic and international.
May Have/Preferred
Experience/education with therapeutic knowledge in gene therapy products.
Experience in conducting clinical trials in rare diseases in the neuromuscular disease area
Continually educates self on global market issues / trends and product knowledge as it pertains to specific business responsibilities in key therapeutic areas.
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
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled
Type
Full-time
Location
IL, Northbrook
Category
Development

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