Associate Director, Clinical Programs
Location: Waltham, MA 02451, Hybrid preferred
Pay Rate: Up to $140 an hour or about $288,000 a year
Job Type: Long Term Contract
Position Overview
The Associate Director, Clinical Programs is responsible for leading a critical pipeline program, ALKS 4510, an investigational orexin 2 receptor agonist being developed to treat fatigue associated with Multiple Sclerosis and Parkinson's disease.
This is a newly created, standalone role built specifically to support the program as it transitions from Phase 1 into Phase 2—a pivotal stage where trial complexity, scale, and urgency increase significantly (more patients, sites, and operational oversight).
This position requires a hands-on, operational leader who can take full ownership of a study and drive execution in a fast-paced, build-from-scratch environment.
Key Responsibilities
- Serve as the clinical operational lead for the ALKS 4510 program, owning study execution from startup through closeout
- Partner closely with the Clinical Program Manager (CPM) to drive study strategy, timelines, and deliverables
- Lead Phase 2 trial scale-up activities, including site expansion, patient recruitment strategy, and vendor oversight
- Provide hands-on leadership in early and transitional phases where processes and infrastructure are still evolving
- Develop and manage study budgets, including forecasting, accrual tracking, invoice reconciliation, and financial reporting
- Oversee CRO and vendor selection, including RFP processes, contract negotiation, and ongoing performance management
- Act as a key decision-maker in vendor selection and study execution strategy
- Lead cross-functional collaboration across Clinical Ops, Data Management, Regulatory, Safety, and external partners
- Direct study start-up activities, including feasibility, site selection, TMF setup, and regulatory documentation
- Ensure timely and high-quality data collection, UAT, database readiness, and database lock activities
- Monitor study performance, metrics, and timelines, proactively identifying and resolving risks
- Serve as the primary point of contact for study-level updates and stakeholder communication
- Contribute to SOP development, process improvements, and mentorship of junior team members
- Independently manage complex, high-visibility clinical studies with minimal oversight
What They’re Looking For
- Associate Director-level Clinical Trial Manager with true end-to-end study ownership (not just delegated responsibilities)
- Proven ability to operate as a hands-on, proactive leader in fast-moving clinical environments
- Experience leading studies through Phase 1 → Phase 2 transitions strongly preferred
- CNS / Neurology experience highly preferred (MS, Parkinson’s, or related areas)
- Open to other small molecule therapeutic backgrounds; candidates with oncology-only or large molecule-only experience will not be considered
- Prior experience within a CRO environment is acceptable if accompanied by deep study ownership
- Strong ability to build and operationalize programs from the ground up
Qualifications
- Bachelor’s degree in a scientific or healthcare-related field required; advanced degree preferred
- 10+ years of clinical research experience within pharma, biotech, or CRO settings
- Strong working knowledge of GCP/ICH guidelines and global clinical trial regulations
- Demonstrated success managing complex, multi-site clinical trials
- Excellent leadership, organizational, and communication skills
- Strong problem-solving ability with a detail-oriented and execution-focused mindset
General Notes
- This is a high-impact, program-critical role tied directly to the success of a Phase 2 clinical trial
- Ideal for candidates who thrive in fast-paced, evolving environments and enjoy building structure from ambiguity
- Massachusetts-based candidates strongly preferred due to long-term hybrid expectations
- Opportunity to transition into a permanent leadership role within the organization
