[Remote] Senior Clinical Trial Manager / Associate Director at Abata Therapeutics

Remote

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

Minimum 5 years of experience in clinical trial management, preferably in a pharmaceutical or biotechnology company
Proven track record of managing complex clinical trials, including global studies
Strong understanding of regulatory requirements, including ICH/GCP and clinical trial regulations
Excellent leadership and project management skills, with the ability to lead cross-functional teams
Strong analytical and problem-solving skills, with the ability to identify and mitigate risks
Experience with clinical trial data management systems and electronic data capture (EDC) tools
Strong communication and interpersonal skills, with the ability to interact with external partners, including CROs and vendors
Experience with scenario planning, risk benefit analysis, and performance excellence models
Bachelor's degree in Life Sciences, Nursing, or a related field
RN degree or equivalent experience

Responsibilities

Manage and support clinical operations resources, including CRO/vendor partners, vendors, and subcontractors
Lead and support cross-functional study teams, including CROs, vendors, and subcontractors
Develop and implement clinical trial protocols and study and development plans
Create and support scenario planning and risk benefit analyses to inform business decisions
Identify and implement best practices, review measurement systems, and improve operational efficiency
Manage relationships with external partners, including CROs and vendors
Ensure efficient and effective communication and exchange of information across projects and reporting functions
Participate in clinical submission activities
Support the development and implementation of department-level SOPs for clinical trials
Interface with departments within and outside of Dianthus, including Finance, Regulatory, Quality, and Tech Ops

Skills

Key technologies and capabilities for this role

Clinical Trial ManagementClinical Project ManagementGCPICHPatient RecruitmentTrial Site ManagementTrial Plan OptimizationResource Management

Questions & Answers

Common questions about this position

What is the reporting structure for this role?

You will report to the Executive Director, Clinical Development Operations and work with cross-functional team management.

Is this position remote or does it require office presence?

This information is not specified in the job description.

What is the salary or compensation for this role?

This information is not specified in the job description.

What are the key responsibilities of this position?

The role involves oversight and management of clinical trials at a regional or global level, including managing CROs/vendors, leading cross-functional teams, ensuring compliance with ICH/GCP, and contributing to study planning and execution, particularly for the Phase III CIDP study.

What is the company culture like at Dianthus Therapeutics?

The company is driven by continuous innovation with high scientific integrity, building a team that holds core principles at the center of operations to elevate patient care.

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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