Associate Director, Clinical Trial Delivery Unit FSP Oversight Manager
Biogen
17 days ago
Remote friendly (United States)
United States
Clinical Research and Development
What You’ll Do
- Manage up to 20 FSP staff assigned across the portfolio to deliver CTDU’s program and study-level operational objectives.
- Lead resource forecasting and assignment to meet key business drivers and maximize FSP performance within the annual operating plan.
- Develop and revise role-specific SOPs to drive consistency and quality across FSP staff.
- Design and implement training programs in collaboration with FSP vendors and CTDU stakeholders.
- Oversee onboarding and offboarding of FSP resources, ensuring smooth transitions and policy compliance.
- Represent CTDU in FSP vendor governance and oversight activities.
- Monitor and report applicable FSP role performance metrics.
- Partner with CTDU stakeholders to align on goals and promote continuous improvement.
Who You Are
- Proven manager overseeing FSP staff, including resource planning, training, and performance management.
- Extensive clinical operations experience across multiple studies and programs; ability to adapt to an evolving pipeline.
- Strong cross-functional knowledge of drug development and clinical trial phases I–IV across various disease areas.
- Effective line management and mentoring; build strong relationships across organizational levels.
- Strong leadership, communication, organization, problem solving, conflict resolution, and team building.
- In-depth knowledge of GCP, ICH guidelines, and regulatory requirements for clinical development.
- Strong project management skills including risk assessment, contingency planning, and vendor oversight within an insourced FSP model.
- Collaborative mindset with effective internal/external stakeholder partnership.
Required Skills
- Approximately 12 years of clinical research/project management experience, preferably with sponsor and/or FSP vendor managing insourced clinical trials.
- Line management experience (advantageous).
- Excellent communicator and presenter.
- Deep knowledge of project/program management skills.
Preferred Skills
- Experience in a Biotech/Pharma environment.
Benefits
- Medical, Dental, Vision & Life insurances; fitness & wellness programs (fitness reimbursement); short- and long-term disability; paid vacation (minimum 15 days) plus end-of-year shutdown (Dec 26–Dec 31); up to 12 company paid holidays + 3 personal days; sick time; paid maternity and parental leave; 401(k) with company match; employee stock purchase plan; tuition reimbursement up to $10,000/year; Employee Resource Groups participation.
- Manage up to 20 FSP staff assigned across the portfolio to deliver CTDU’s program and study-level operational objectives.
- Lead resource forecasting and assignment to meet key business drivers and maximize FSP performance within the annual operating plan.
- Develop and revise role-specific SOPs to drive consistency and quality across FSP staff.
- Design and implement training programs in collaboration with FSP vendors and CTDU stakeholders.
- Oversee onboarding and offboarding of FSP resources, ensuring smooth transitions and policy compliance.
- Represent CTDU in FSP vendor governance and oversight activities.
- Monitor and report applicable FSP role performance metrics.
- Partner with CTDU stakeholders to align on goals and promote continuous improvement.
Who You Are
- Proven manager overseeing FSP staff, including resource planning, training, and performance management.
- Extensive clinical operations experience across multiple studies and programs; ability to adapt to an evolving pipeline.
- Strong cross-functional knowledge of drug development and clinical trial phases I–IV across various disease areas.
- Effective line management and mentoring; build strong relationships across organizational levels.
- Strong leadership, communication, organization, problem solving, conflict resolution, and team building.
- In-depth knowledge of GCP, ICH guidelines, and regulatory requirements for clinical development.
- Strong project management skills including risk assessment, contingency planning, and vendor oversight within an insourced FSP model.
- Collaborative mindset with effective internal/external stakeholder partnership.
Required Skills
- Approximately 12 years of clinical research/project management experience, preferably with sponsor and/or FSP vendor managing insourced clinical trials.
- Line management experience (advantageous).
- Excellent communicator and presenter.
- Deep knowledge of project/program management skills.
Preferred Skills
- Experience in a Biotech/Pharma environment.
Benefits
- Medical, Dental, Vision & Life insurances; fitness & wellness programs (fitness reimbursement); short- and long-term disability; paid vacation (minimum 15 days) plus end-of-year shutdown (Dec 26–Dec 31); up to 12 company paid holidays + 3 personal days; sick time; paid maternity and parental leave; 401(k) with company match; employee stock purchase plan; tuition reimbursement up to $10,000/year; Employee Resource Groups participation.