Senior Clinical Trial Manager

Marea Therapeutics, Inc.; South San Francisco (CA); Presencial; USD 180 000 - 220 000; Tempo integral

Resumo da oferta

Marea Therapeutics, Inc. in South San Francisco is seeking a Senior Clinical Trial Manager to lead day-to-day execution of MAR002 studies, ensuring trials run on time, within budget, and comply with GCP.

The Sr. CTM will oversee trial start-up, enrollment, maintenance, and close-out, manage CROs and vendors, mentor junior staff, and support regulatory submissions for Phase 2/3 activities toward product registration.

Qualificações

• BA/BS or higher degree in a relevant scientific discipline.
• 6–9 years of clinical research/operations experience.
• Global Ph 2–3 trial experience preferred.
• Strong vendor management and cross-functional collaboration skills.
• ICH-GCP knowledge and regulatory awareness.

Responsabilidades

• Lead the Study Management Team (SMT) for assigned clinical study.
• Oversee CROs and vendors on a product level; monitor KPIs and milestones.
• Identify, plan, and mitigate risks in study conduct and recruitment efforts.
• Provide input on trial design and regulatory submissions; develop key study documents.
• Manage study budgets and contribute to process improvements within Clinical Operations.

Conhecimentos

Clinical operations

Study management

Vendor management

Cross-functional teams

GCP compliance

Regulatory submissions

Budget management

Leadership

Formação académica

BA/BS or higher degree

Descrição da oferta de emprego

Marea Therapeutics is a clinical-stage biotechnology company based in South San Francisco with a growing pipeline of first-in-class therapies to address genetically validated cardioendocrine disease targets. Our therapies have the potential to serve as transformative treatment options for significant patient populations living with cardioendocrine diseases.

The company’s lead program, MAR001, is being developed for the treatment of severe hypertriglyceridemia (sHTG), a condition characterized by very high triglyceride levels and elevated risk of acute pancreatitis. Preclinical models with MAR001 demonstrated reduction in triglycerides, remnant cholesterol and ectopic fat, and improved insulin sensitivity. MAR001 has demonstrated strong and a differentiated profile in patients and is approaching Phase 3 development. Our second clinical asset, MAR002, is a monoclonal antibody targeting excess growth hormone produced by the pituitary gland in the rare hormonal disorder, acromegaly. MAR002 has potential to become best-in-disease and is quickly progressing into Phase 2/3 clinical development. We also have a third asset that is swiftly advancing through research discovery, with DC nomination expected this year.

At Marea, we believe in the power of collaboration and the importance of leading by example. We are a tight-knit team that values the contributions of every member, from interns to senior leaders. Our environment is dynamic, with each day presenting new challenges and opportunities for growth. Every role is “Hands-On”, and the successful candidate will be able to work alongside team members, regardless of level, to understand challenges and drive results.

ABOUT THE ROLE

Reporting to the Director of Clinical Operations, the Senior Clinical Trial Manager (Sr. CTM) will lead the day-to-day execution and management of clinical trials, ensuring studies are conducted efficiently, on time, within budget, and in compliance with GCP and regulatory requirements.

This role is a hands-on operational leader at the study level, responsible for driving execution across study start-up, enrollment, maintenance, and close-out activities. The Sr. CTM will work closely with cross-functional partners and oversee CROs and vendors to ensure high-quality delivery of clinical trial milestones. There may be the opportunity to mentor junior members of the Marea team.

In this role, the Sr. CTM will be a key clinical operations leader supporting our MAR002 program, specifically driving the execution of a Ph. 2/3 study to support product registration. MAR002 is a first-in-class- and potentially a best in disease anti-growth hormone receptor antibody monoclonal antibody indicated for growth hormone control (IGF-1 normalization) in acromegaly.

This is a full-time, South San Francisco-based position with the expectation of working on-site at least three days per week.

KEY RESPONSIBILITIES

• Support program lead with setting and timely executing the development strategies for the clinical studies.
• Responsible for the strategic and operational oversight, management, execution, and delivery of the clinical studies for MAR002 and related clinical program activities.
• Lead the Study Management Team (SMT) for assigned clinical study.
• Resolve and/or escape issues raised by the clinical operations team or the SMT.
• Ensure consistency between studies for assigned clinical program.

CRO and Vendor Management

• Support vendor selection, including request for proposals, leading bid defense meetings, critical review of contracts and negotiation of work orders.
• Oversee CROs and other selected vendors on a product level including setting and monitoring key performance indicators and ensuring successful execution of the clinical program/studies and may co-lead operational governance meetings.

Study Planning, Risk Mitigation, and Enrollment

• Identification and oversight of potential challenges or risks with clinical study conduct and implementation of mitigation plans.
• Support the development and execution of clinical site engagement and subject recruitment strategies for assigned study.

Trial Design, Documentation, and Submissions Support

• Provide input and clinical operations perspective on clinical trial design.
• Author, provide input and/or oversee the development of key study level documents as well as provide support for regulatory submissions.

Study Budget Management & Operational Excellence

• Oversee financial aspects of assigned clinical study, including preparing related operating plans and ensuring adherence to planned study budgets.
• Support Clinical Operations department head with strategic initiatives and the implementation of those initiatives for process and operational improvements.

Inspection Readiness, Quality, and SOP Support

• Oversee/co-lead inspection readiness activities as it relates to clinical study execution and act as subject matter expert during regulatory inspections.
• Support Clinical Operations department on ad hoc initiatives to leverage best practices as well as new technologies and applications for clinical study conduct.

KEY RESPONSIBILITIES

Study Execution Leadership & Management

• Support program lead with setting and timely executing the development strategies for the clinical studies.
• Responsible for the strategic and operational oversight, management, execution, and delivery of the clinical studies for MAR002 and related clinical program activities.
• Lead the Study Management Team (SMT) for assigned clinical study.
• Resolve and/or escape issues raised by the clinical operations team or the SMT.Ensure consistency between studies for assigned clinical program.

CRO and Vendor Management

• Support vendor selection, including request for proposals, leading bid defense meetings, critical review of contracts and negotiation of work orders.
• Oversee CROs and other selected vendors on a product level including setting and monitoring key performance indicators and ensuring successful execution of the clinical program/studies and may co-lead operational governance meetings.

Study Planning, Risk Mitigation, and Enrollment

• Identification and oversight of potential challenges or risks with clinical study conduct and implementation of mitigation plans.
• Support the development and execution of clinical site engagement and subject recruitment strategies for assigned study.

Trial Design, Documentation, and Submissions Support

• Provide input and clinical operations perspective on clinical trial design.
• Author, provide input and/or oversee the development of key study level documents as well as provide support for regulatory submissions.

Study Budget Management & Operational Excellence

• Oversee financial aspects of assigned clinical study, including preparing related operating plans and ensuring adherence to planned study budgets.
• Support Clinical Operations department head with strategic initiatives and the implementation of those initiatives for process and operational improvements.

Inspection Readiness, Quality, and SOP Support

• Oversee/co-lead inspection readiness activities as it relates to clinical study execution and act as subject matter expert during regulatory inspections.
• Support Clinical Operations department on clinical SOP development.
• Support Clinical Operations department on ad hoc initiatives to leverage best practices as well as new technologies and applications for clinical study conduct.

QUALIFICATIONS

• BA/BS or higher degree in a relevant scientific discipline required.
• Significant experience (6 - 9 years) of clinical research / clinical operations and organizational management within the pharmaceutical industry; Biotech/small pharma experience preferred.
• Global Ph 2 – 3 clinical trial experience required
• Experience leading and working on cross functional study execution teams.
• Demonstrated ability to present complex information to management, vendors and external audiences.
• Demonstrated ability to manage and communicate effectively with vendors including negotiating contracts, drafting and reviewing request for proposals, analyzing scope of work, responding to inquiries and complaints.
• Strong attention to detail and ability to generate high quality work outputs (e.g. presentations, reports, dashboards, etc.)
• 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 Clinical Operations team in doing the same.
• Excellent written and oral communication skills.
• High level of professionalism with internal and external stakeholders.
• Demonstrated problem-solving skills and conflict management skills.
• In-depth knowledge of current regulatory requirements and guidelines governing clinical research (e.g., ICH-GCP).

• BA/BS or higher degree in a relevant scientific discipline required.
• Significant experience (6 - 9 years) of clinical research / clinical operations and organizational management within the pharmaceutical industry; Biotech/small pharma experience preferred.
• Global Ph 2 – 3 clinical trial experience required
• Experience leading and working on cross functional study execution teams.
• Demonstrated ability to present complex information to management, vendors and external audiences.
• Demonstrated ability to manage and communicate effectively with vendors including negotiating contracts, drafting and reviewing request for proposals, analyzing scope of work, responding to inquiries and complaints.
• Strong attention to detail and ability to generate high quality work outputs (e.g. presentations, reports, dashboards, etc.)
• 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 Clinical Operations team in doing the same.
• Excellent written and oral communication skills.
• High level of professionalism with internal and external stakeholders.
• Demonstrated problem-solving skills and conflict management skills.
• In-depth knowledge of current regulatory requirements and guidelines governing clinical research (e.g., ICH-GCP).

PAY RANGE

The salary range for this role is $180,000. - $220,000. Compensation and title will be competitive and commensurate with the candidate's experience, qualifications, and the responsibilities of the position.

WORKING CONDITIONS

• Prolonged periods of being at a stationary desk or work computer
• Ability to occasionally adjust, handle, or move objects up to [20] pounds
• Transparently and timely communicating with others to exchange information
• Occasional travel as required to meet business objectives

We do 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. We invite applications from minorities, women, the disabled, protected veterans, and all other qualified applicants.

We invite applicants to share their demographic background. If you choose to complete this survey, you will be provided a short questionnaire that is voluntary and will not be considered in the hiring process or otherwise. The information collected will be aggregated and reported as required under the Equal Employment Opportunity Commission and relevant laws relating to the reporting of demographic data.

As set forth in Marea Therapeutics’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.