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

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Not SpecifiedCompensation

N/AExperience Level

N/AJob Type

Not SpecifiedVisa

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Requirements

Minimum 5 years of experience in clinical trial management, preferably in a pharmaceutical or biotechnology company
Strong understanding of clinical trial regulations, including ICH/GCP and regulatory compliance
Experience in managing cross-functional teams, including CRO/vendor partners and external service providers
Proven track record of leading and managing clinical trials, with a focus on quality and efficiency
Strong analytical and problem-solving skills, with the ability to identify and mitigate risks
Excellent communication and interpersonal skills, with the ability to interact with internal and external stakeholders
Experience with scenario planning, risk benefit analyses, and models of performance excellence
Strong understanding of clinical trial protocols, study and development plans, and department-level SOPs
Experience with clinical data review and submission activities
Fluency in English and Mandarin

Responsibilities

Manage and support internal and external clinical operations resources
Contribute to strategy, tactics, and driving execution of global clinical studies
Influence, manage, and lead 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
Leads and supports cross-functional study team to successfully manage external service providers
Leads/participates in clinical data review
Develop and operational design, planning, and strategy of clinical trial protocols and study and development plans
Creates/supports scenario planning and risk benefit analyses to make recommendations to align with corporate strategies
Contribute to models of performance excellence by identifying best practices, reviewing measurement systems, and improving operational efficiency
Manage relationships with vendor partners and suppliers in clinical programs to optimize delivery
Ensures efficient and effective communication and exchange of information across projects and reporting functions
May participate in Clinical submission activities
Supports 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

Skills

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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