Associate Director Clinical Development 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 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.

The Role

The Associate Director, Clinical Development will provide clinical leadership on a gene therapy program (role may extend to other gene therapy programs over time). Working closely with the global medical lead, the Director supports the design, implementation, monitoring, analysis, and reporting of clinical studies conducted within the program. In addition, they will collaborate with the cross functional team to develop long-range strategic plans for the program and execute upon these plans. The current focus of drug development 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.

Primary Responsibilities

Work together with the global medical lead to support clinical development activities including preparation of regulatory submissions for the target clinical program.

Support activities related to all current and planned clinical trials (e.g., develop protocols, investigator brochures, and clinical study reports and review clinical trial documents, CRO management, clinical support of regulatory interaction, and study analysis and reporting).

Partner with Research, Regulatory Affairs, Non-Clinical Science, and Medical Affairs to ensure timely and effective clinical and scientific input into overall program.

Support and/or lead investigator meetings and lead site initiation visits with clinical trial investigators, and partner with Clinical Operations and Medical Affairs in driving enrollment into the clinical studies or registries

Represent the company at scientific meetings, patient advocacy events and other public relations opportunities

Study Data Review and Analysis

Provide clinical input into statistical planning, data analysis and interpretation

Perform ongoing review and analysis of study data

Provide clinical leadership and support for publication of data (manuscripts, posters, etc.) and disease or technology related scientific publications

Support efforts to develop strategic partnerships with Key Opinion Leaders

Together with the Global Medical Lead monitor safety and prepare safety related analysis for DMC forums or regulatory submissions

Requirements

Must Have/Required

Advanced degree in a relevant scientific discipline; health science or clinical discipline with 10 years' clinical, scientific/research, pathology or industry related experience or combination of academia and industry.

5 years' biotechnology/pharmaceutical 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

Prior BLA experience in rare/orphan diseases

Experience in scientific research and/or clinical practice (as evidenced by appropriate qualifications, publications and/or relevant accreditation)

Hands on experience managing publications processes and strategy

Strong computer skills including MS Office Suite (Word, Excel, PowerPoint, Outlook, MS Project) and in the use of industry-standard software (eg. electronic data capture systems [RAVE, InForm, etc.]) and proficient in data analysis software (Excel, SigmaPlot, SPSS, R, etc.)

A history of strong collaboration and personal interaction with all levels of internal stakeholders including, Regulatory Affairs, Medical Affairs, Clinical Operations, Biometrics, Research, Preclinical Science and Product Development

Demonstrated success working with and influencing key external stakeholders (KOLs, investigators, researchers) including presenting/responding to health authorities

Knowledge of global pharmacovigilance standards and guidance documents

Comfortable working in a flexible, dynamically changing and (at times) challenging environment

Excellent strategic planning, organizational and communication skills

Highest level of scientific integrity

Models our Core Values: Be Bold, Care Deeply, #GetStuffDone -- is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted

Willingness to travel ~25%, with international travel at times

May Have/Preferred

Ph.D. or PharmD degree

Experience with gene therapy is preferred

Knowledge and proficiency related to medical affairs activities including registries

Knowledge and proficiency related to gene therapy and neuromuscular diseases

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

Company info

Astellas Us, LLC
Website : https://www.astellas.com/us/