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

Remote

Abata Therapeutics Logo
Not SpecifiedCompensation
N/AExperience Level
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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

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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