Senior Clinical Trial Manager at Abata Therapeutics

San Carlos, California, United States

Abata Therapeutics Logo
$150,000 – $220,000Compensation
Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Biotechnology, PharmaceuticalsIndustries

Requirements

Candidates must possess a Bachelor's or advanced degree in life sciences, nursing, or a related field, with a minimum of 7 years of experience in clinical trial management within biotech, pharmaceutical industry, or a CRO. Essential skills include excellent leadership, team management, communication (written and verbal), interpersonal, organizational, multitasking, project management, analytical, problem-solving, and decision-making abilities, along with meticulous attention to detail and a strong focus on data integrity. Proficiency with clinical trial management systems (CTMS), Electronic Data Capture (EDC) systems, and standard MS Office software is required, as is a strong understanding of regulatory submission processes and global regulatory requirements. Previous experience as a Clinical Research Associate (CRA) and demonstrated experience with Phase 1-2 trials are preferred.

Responsibilities

The Senior Clinical Trial Manager will lead global, multi-phase clinical trials from initiation through closeout, overseeing vendors and CROs to ensure compliance with GCP and regulatory guidelines, and maintaining trial quality, timelines, and budget. Key duties include developing and implementing operational plans, coordinating all trial-related activities such as site selection and patient recruitment, managing study timelines and budget, conducting progress meetings, ensuring adherence to GCP and regulatory requirements, overseeing trial document creation and maintenance, participating in Health Authority inspections and audits, serving as the primary contact between sponsor, investigators, sites, and functional teams, providing regular study updates to management, and managing external vendor performance. The role involves cross-functional collaboration and up to 25% travel for site visits and trial oversight.

Skills

Clinical Trial Management
GCP
Regulatory Compliance
Study Management
Vendor Management
Cross-functional Collaboration
Project Management
Site Selection
Patient Recruitment
Data Integrity
Budget Management

Abata Therapeutics

Develops therapies for autoimmune diseases

About Abata Therapeutics

Abata Therapeutics develops therapies for autoimmune diseases, focusing on type 1 diabetes. Their main product, ABA 201, is a Treg cell therapy aimed at patients with some remaining beta cell function. This therapy works by utilizing regulatory T cells to improve patient outcomes. Unlike many competitors, Abata targets a specific niche within the autoimmune disease market and collaborates with partners like ElevateBio for process development and manufacturing. The company's goal is to transform treatment options for autoimmune diseases through advanced research and development.

Cambridge, MassachusettsHeadquarters
2021Year Founded
$184.8MTotal Funding
EARLY_VCCompany Stage
BiotechnologyIndustries
11-50Employees

Risks

Intensifying competition from companies like Sangamo Therapeutics may impact Abata's market share.
Stringent FDA scrutiny on manufacturing could delay Abata's clinical trials.
Rising clinical trial costs pose financial risks to Abata's pipeline progression.

Differentiation

Abata focuses on Treg cell therapies for autoimmune diseases like MS and diabetes.
Their lead product, ABA 201, targets type 1 diabetes with remaining beta cell function.
Abata's strategic partnership with ElevateBio enhances their manufacturing capabilities.

Upsides

Recent investment from Bristol Myers Squibb boosts Abata's Treg therapy pipeline development.
FDA's accelerated approval pathways may expedite Abata's clinical trials.
Growing autoimmune disease prevalence increases demand for Abata's innovative treatments.

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