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About the Role

The Associate Director, Clinical Operations will provide leadership and operational oversight for clinical studies, ensuring milestones, company goals, and budget adherence. This role involves program-level accountability for timelines, budget, quality, risk management, and GCP compliance. The position will collaborate cross-functionally, oversee CROs and vendors, and potentially mentor junior staff. The Associate Director will be a key leader supporting the MAR001 program, driving study start-up, vendor oversight, and delivery of high-quality late-phase clinical data.

Responsibilities

Support program lead with setting and timely executing development strategies for clinical studies.
Provide strategic and operational oversight, management, execution, and delivery of clinical studies for MAR001 and related clinical program activities.
Lead the Study Management Team (SMT) for assigned clinical study.
Resolve and/or escalate issues raised by the clinical operations team or the SMT.
Ensure consistency between studies for the assigned clinical program.
Support vendor selection, including RFP process, bid defense meetings, contract review, and work order negotiation.
Oversee CROs and other selected vendors on a product level, setting and monitoring KPIs, and ensuring successful execution of clinical programs/studies.
Act as the main escalation point of contact for strategic CRO partners and internal stakeholders.
Identify and oversee potential challenges or risks with clinical study conduct and implement mitigation plans.
Develop and execute clinical site engagement and subject recruitment strategies.
Provide input and clinical operations perspective on clinical trial design.
Author, provide input, and/or oversee program and study level documents to support clinical studies and regulatory submissions.
Oversee financial aspects of assigned clinical studies, including operating plans and budget adherence.
Oversee resource planning for assigned studies to support departmental management.
Support departmental strategic initiatives and implementation for process and operational improvements.
Oversee/co-lead inspection readiness activities related to clinical study execution and act as a subject matter expert during inspections.
Support clinical SOP development.
Support ad hoc initiatives to leverage best practices, new technologies, and applications for clinical study conduct.

Requirements

BA/BS or higher degree in a relevant scientific discipline required.
Significant experience (10+ years) of clinical research / clinical operations and organizational management within the pharmaceutical industry; Biotech/small pharma experience preferred.
Global clinical trial research experience preferred.
Experience in phases 1-3 preferred; global phase 2-3 experience necessary.
Experience leading cross-functional teams.
Demonstrated ability to present complex information to management, vendors, and external audiences.
Demonstrated ability to create and manage one or more program budgets, including communication of overspend/underspend.
Demonstrated ability to manage and communicate effectively with vendors, including contract negotiation, RFP drafting/review, scope of work analysis, and inquiry response.
Strong attention to detail and ability to establish priorities for the team.
Demonstrated ability to work in a fast-paced environment with multiple competing tasks and demands, across multiple time zones.
Demonstrated ability to work independently, take initiative, complete tasks to deadlines, and support the Clinical Operations team.
Demonstrated ability to lead, motivate, and mentor staff and teams.
Excellent written and oral communication skills.
High level of professionalism with internal and external stakeholders.
Demonstrated ability to remove barriers to success.
In-depth knowledge of current regulatory requirements and guidelines governing clinical research (e.g., ICH-GCP).
Previous line management or direct management of team members.

Skills

Clinical Operations
GCP Compliance
CRO Management
Vendor Management
Clinical Study Design
Budget Management
Risk Management
Regulatory Submissions
Team Leadership
Mentoring
Communication Skills
Problem-Solving

Location

South San Francisco

Work Type

Full-time
On-site (at least three days per week)

Experience Level

10+ years clinical research/operations experience
Associate Director level
Global phase 2-3 experience

Education Level

BA/BS or higher degree in a relevant scientific discipline

Salary/Compensations

$190,000 - $210,000

About the Company

Marea Therapeutics is a clinical-stage biotechnology company focused on developing first-in-class therapies for cardioendocrine diseases.
The company's lead program, MAR001, is in development for severe hypertriglyceridemia (sHTG) and is approaching Phase 3.
MAR002, a monoclonal antibody targeting excess growth hormone for acromegaly, is progressing into Phase 2/3 development.
A third asset is advancing through research discovery with DC nomination expected this year.
Marea fosters a collaborative, dynamic, and hands-on environment where every team member's contribution is valued.
The company believes in leading by example and supporting growth opportunities for all employees.

Equal Opportunity

Marea Therapeutics does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual’s status in any group or class protected by applicable federal, state, and local law.
Applications are invited from minorities, women, the disabled, protected veterans, and all other qualified applicants.