[Remote] Senior Clinical Trial Manager- APAC at Abata Therapeutics

Remote

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

BiotechnologyIndustries

Requirements

Undergraduate (Life Sciences preferred) degree, RN degree, or equivalent; advanced degree desirable
Experience in the pharmaceutical or biotechnology industry (inferred from context)
Fluency in English and Mandarin

Responsibilities

Manage and support relevant internal and external clinical operations resources while contributing to strategy, tactics, and driving execution of global clinical studies
Influence, manage and lead the planning, budgeting, and study management processes in global clinical studies
Accountable for oversight and management of CRO/vendor partners contracted to the study/region assigned
Lead and support the cross-functional study team to successfully manage external service providers (including CRO(s), vendors, and subcontractors), ensuring project deliverables are executed on time and within budget, while taking on clinical trial management (CTM) role as needed
Lead/participate in clinical data review
Contribute to the development and operational design, planning, and strategy of clinical trial protocols and study and development plans
Create/support scenario planning and risk benefit analyses to make recommendations aligning with corporate strategies
Contribute to models of performance excellence by identifying best practices, reviewing measurement systems, and improving operational efficiency in the department
Manage relationships with vendor partners and suppliers in clinical programs to optimize delivery
Ensure efficient and effective communication and exchange of information across projects and reporting functions
May participate in clinical submission activities
Support the development and implementation of department-level SOPs for clinical trials and related activities
Interface with departments within and outside of Dianthus, including Finance, Regulatory, Quality, and Tech Ops
Represent the company at Investigator Meetings
Other such duties as may be determined or assigned

Skills

Key technologies and capabilities for this role

Clinical Trial ManagementGCPICHPatient RecruitmentSite ManagementClinical OperationsProject ManagementMandarin

Questions & Answers

Common questions about this position

What language skills are required for this role?

Fluency in English and Mandarin is required to be successful in this role.

Is this position remote or does it require a specific location?

This information is not specified in the job description.

What is the salary or compensation for this position?

This information is not specified in the job description.

What does the company culture emphasize?

The company emphasizes continuous innovation with high scientific integrity, core principles at the center of operations, and elevating patient care.

What experience makes a strong candidate for this role?

Strong candidates have experience managing clinical trials, overseeing CROs and vendors, leading cross-functional teams, and ensuring compliance with ICH/GCP regulations, particularly in APAC for Phase II/III studies.

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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