Senior/Project Manager Clinical Development

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 Project Manager, Clinical Development position plays a key role in our Clinical Development department. The role is for an experienced project manager that strategically supports the clinical development and business objectives of several therapeutic areas across the product life cycle.

The Project Manager will develop, plan, direct and manage projects associated with implementation of clinical assays and execution of clinical trials.

Responsibilities:

Develop and maintain project plans, timelines, and strategic development plans in collaboration with team leads and cross-functional team members.

Manage project teams with strong communication and interpersonal relationship skills to ensure project objectives and milestones are reached.

Direct and coordinate the activities of internal cross-functional project team members (Clinical Science, Clinical Development, Clinical Operations, Bioanalytical, Biometrics, Non-clinical, Quality Assurance, and Regulatory Affairs), demonstrating a strong ability to function well in a team environment.

Facilitate team meetings, cross-functional communication and decision making, ensuring alignment with internal and external stakeholders.

Conduct regular project meetings with CROs and external collaborators and generate meeting minutes and action items.

Provide decision making methodologies, identify bottleneck and inconsistencies within interdependencies and facilitate brainstorming with the teams to help identify project issues and resolutions.

Guide and assist team in implementation and execution of bioanalytical assays (molecular, biochemical, immunological, and translational biomarkers) and project deliverables within study timelines, while enforcing GxP compliance.

Collaborate with Bioanalytics and CRO's and serve as point of contact as needed in assuring successful method implementation, preparation of study related documentations, and helping ensure the integrity of the data obtained during clinical study conduct.

Support vendor/laboratory engagement and oversight to ensure data quality and integrity.

Assist in budget and contract preparation, review and invoicing.

Assist the team with other similar duties and responsibilities as needed.

Requirements

Must Have/Required

BS/MS degree in life sciences or related field, with 8 years of scientific, clinical, or industry experience, including 4 years in Project Management.

Excellent understanding of Project Management knowledge tools (MS Office Suite, MS Project, Smartsheet, etc.), techniques, and culture.

Strong practical knowledge of bioanalytical method development, validation, troubleshooting, and regulatory and industry guidelines.

Excellent communication skills and ability to lead and influence team members, subject matter experts,

and external collaborators/vendors.

Track record of leading development projects through various phases of research or clinical development.

Excellent organizational skills, including attention to detail and multi-tasking skills.

Capable of motivating others in a dynamic and fast-pace environment. Ability to shift and change priorities as needed.

Must be a self-starter with the aptitude to work independently and use sound judgment and influencing skills.

Knowledge of GCP, GLP, and other regulatory requirements.

May Have/Preferred

Experience in rare diseases, neuromuscular diseases, or in

gene therapy area.

Knowledge of clinical trial methodology, regulatory and compliance requirements.

#LI-SS

Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled

Type

Full-time

Location

IL, Northbrook

Category

Development Project Management

Company info

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