Associate Director Clinical Operations

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