Clinical Trial Manager en Marea Therapeutics Inc

Description

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

Incubated by Third Rock Ventures, Marea completed a Series B financing in June 2024 and is well funded by a syndicate of life science investors including Sofinnova, Forbion, Perceptive Advisors, Xontogeny, venBio, Omega Funds, Surveyor, Alpha Wave and Third Rock Ventures.  The company’s lead program is in Phase 2 clinical development (MAR001) and a second program is progressing towards clinical development in a rare cardiometabolic disease.  Marea is a fast-growing company looking for extraordinary individuals to join our team who want to make a difference in the lives of millions of people living with cardiometabolic diseases. The company is led by a dynamic team of scientists and company builders with deep knowledge and experience in cardio-endocrine diseases, human genetics, and adipocyte biology.    

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. 

SUMMARY

The Clinical Trial Manager will provide operational and technical expertise to help plan and execute Marea sponsored clinical trials in alignment with corporate goals and objectives.  This individual will initially be asked to manage key operational management components of a global phase 2 trial for Marea’s leading cardiometabolic program under the supervision of the Marea Study Lead and may be asked to provide back-up support for other trials as needed.  This individual will eventually take on a Study Lead role for new trials downstream.  The Clinical Trial Manager will partner with the Clinical Operations Team to build and develop fit-for-purpose internal infrastructure and processes to support Marea-sponsored trials.  

This is a full-time position, with a strong preference for candidates that can work on-site at least three days per week in the San Francisco-based office.  

Requirements

Study Management

·  Support global phase 2 Study Lead to ensure that all key trial milestones and activities are completed on-time and within budget, by managing key components of the trial.  

·  Support the development and maintenance of key trial documents such as protocols, ICFs, study plans, etc. 

·  Lead critical site and trial management activities such as ICF review, site activations, tracking monitoring visit scheduling, review monitoring visit reports. 

·  Generate and maintain internal trial management trackers and reports.  

CRO & Vendor Oversight 

·  Participate in routine CRO meetings to support management of clinical trial(s) to support study start-up, interim, and close-out activities.  

·  Manage ancillary vendors supporting clinical trials; lead routine meetings with ancillary vendors.  

·  Track timely scheduling of monitoring visits; track and review timely completion and monitoring visit reports.  

·  Conduct co-monitoring visits with CRO CRAs as needed.  

·  Oversee eTMF activities at CRO, including final reconciliation of eTMF prior to transfer to Marea at end of trial.  

Clinical Trial Quality & Compliance 

·  Partners with Study Lead to ensure Marea sponsored clinical trials are conducted in accordance with ICH GCPs; contribute to any inspection readiness activities as appropriate for each phase of clinical development.   

·  Partners with internal and external data management lead to ensure high quality and timely data.  

·  Track and identify any trends or signals while performing routine review of study data listings, trackers, or monitoring visit reports.  

Department Support  

·  Lead department process improvement initiatives and SOP development as needed. 

·  Support maintenance of internal organization and storage of study documents and files.  

·  Participate in the interview process for similar or junior roles in Clinical Operations. 

Mentor and support junior staff as needed.  

QUALIFICATIONS

·  Bachelor’s degree required in life science or health related field; advanced degree preferred.

·  At least 5 years of clinical trials management experience at a biopharma sponsor or CRO.  

·  Experience in cardiometabolic or other common disease drug development experience, with strong grasp of fundamentals of clinical trial design and execution as well as the overall clinical development process.  

·  Proven track record of working on ph 1 trials to global ph 2/3 trials.  

·  Working knowledge of ICH guidelines, FDA/EMA regulations.  

·  Experience with managing CROs and clinical trial vendors in a hybrid insource / outsource model, including tracking vendor performance management and managing vendor budgets and invoices.  

·  Requires project management skills, strong organization, and time management skills along with study leadership abilities 

·  Self-motivated, with initiative and the ability to take ownership of, and follow through with specific tasks or assigned projects

·  Work with limited supervision both independently and as part of a team with the ability to handle competing priorities 

·  Flexible and willing to roll up your sleeves and be hands on in a dynamic start-up environment, taking on a wide range of clinical operations tasks as needed.  

·  Travel domestically and internationally as required to carry out responsibilities

·  Ability to read and understand scientific literature

·  Must have excellent interpersonal, written, and verbal communication skills 

·  Strong computer experience and demonstrated proficiency in MS Office (Outlook, G-Suite, MS Word, Excel, PowerPoint)

·  Demonstrated leadership skills and equally able to be a strong team player.  

·  Ability to travel up to 30% as needed.