oracle
Director, Clinical Program Management
Alkermes
Waltham, USA
Full-time
Director · 10+ years experience
Onsite
Discovered 5 days ago
gcp
Key Skills for This Role
gcp
Full Job Posting
Basic Qualifications:
- Bachelor’s Degree in life sciences or healthcare-related field; Master’s Degree preferred.
- Minimum of 10 years of clinical development experience in a pharmaceutical/biotech or CRO setting.
Preferred Qualifications:
- Proven track record of leading global, complex clinical programs across multiple phases, with deep experience in Phase 4/LCM programs
- Strong leadership presence with the ability to influence and drive alignment across cross-functional teams.
- Excellent strategic thinking, organizational, and execution skills with the ability to manage competing priorities.
- Strong knowledge and understanding of GCP/ICH Guidelines and regulatory requirements.
- Physical Demands and Work Environment:
- Ability to travel domestically and internationally (up to 20%)
- The annual base salary for this position ranges from $219,626 to $235,120. In addition, this position is eligible for an annual performance pay bonus. Exact compensation may vary based on skills, training, knowledge, and experience. Alkermes offers a competitive benefits package. Additional details can be found on our careers website: www.alkermes.com/careers#working-here
- #LI-HB1
- Bachelor’s Degree in life sciences or healthcare-related field; Master’s Degree preferred.
Responsibilities
- Responsible for planning, oversight and execution of assigned clinical programs: responsible for timelines, budget, and key deliverables as well as contributing to overall clinical strategy
- Participates on Clinical Teams as operational representative, partnering closely with Clinical Science, Biostatistics, Regulatory, Medical Affairs, Translational Medicine, and other functions to shape and execute integrated clinical development plan
- Responsible for project budget/resource planning, re-forecasting, milestone, payment and variance tracking with Clinical Outsourcing & Finance, and Project Management.
- Establish and monitor program performance metrics, leveraging data and insights to continuously improve execution and inform leadership decision-making.
- Provides strategic input and oversight in development of clinical plans, protocols, SAPs, consent form development, and other program/study related documents.
- Works with clinical outsourcing, legal, and finance in the selection of CROs and vendors, and participates in contract and budget negotiations.
- Manages relationships and establishes strong partnerships with CROs, vendors, investigators and other external partners to ensure delivery of high-quality, timely outcomes.
- Partner with the Study Start-Up team on clinical start-up activities including feasibility, country selection/recommendation, budget & timeline planning, supply chain, and regulatory preparation.
- Provides oversight for project-related data integration/technology activities including IVRS, ePRO, central lab, etc along with data management department.
- Provides oversight and support to direct reports fostering talent development, performance management, and a culture aligned with Alkermes leadership expectations and values.
About Alkermes
Apply for this job in 1 click
Skip the repetitive application forms
Install the Base Career Chrome Extension and autofill job applications across major job boards with your profile.
Trusted by over 500,000 job seekers on Base Career
More from this employer
More jobs at Alkermes
Director, Patient Strategy & Marketing, Alixorexton
Waltham, USA
DirectorFull-time
Discovered TodayView →
Territory Business Manager Psychiatry – Boston South / Rhode Island / Cape Cod
Providence, USA
ManagerFull-time
Discovered TodayView →
Director, Patient Strategy & Marketing, Alixorexton
Waltham, USA
DirectorFull-time
Discovered TodayView →
Territory Business Manager, Rare Disease – Seattle
Seattle, USA
ManagerFull-time
Discovered 3 days agoView →
Territory Business Manager, Rare Disease – Seattle
Seattle, USA
ManagerFull-time
Discovered 3 days agoView →
Manager, Process Development
Wilmington, USA
ManagerFull-time
Qualifications Requirements: Bachelor’s Degree in Pharmaceutical Manufacturing, Chemical Engineering or a related field and ten years of experience in pharmaceutical solid oral dosage processing. Experience must include
Discovered 4 days agoView →
Director, Patient Strategy & Marketing, Alixorexton
Waltham, USA
Discovered TodayFull-time
Territory Business Manager Psychiatry – Boston South / Rhode Island / Cape Cod
Providence, USA
Discovered TodayFull-time
Director, Non-Personal Promotion, Alixorexton
Waltham, USA
Discovered TodayFull-time
Director, Patient Strategy & Marketing, Alixorexton
Waltham, USA
Discovered TodayFull-time
Director, Non-Personal Promotion, Alixorexton
Waltham, USA
Discovered TodayFull-time
Territory Business Manager, Rare Disease – Seattle
Seattle, USA
Discovered 3 days agoFull-time
Territory Business Manager, Rare Disease – Seattle
Seattle, USA
Discovered 3 days agoFull-time
Manager, Process Development
Wilmington, USA
Discovered 4 days agoFull-time