[Remote] Senior Director, Clinical Operations at Abata Therapeutics

Remote

Abata Therapeutics Logo
Not SpecifiedCompensation
N/AExperience Level
N/AJob Type
Not SpecifiedVisa
N/AIndustries

Requirements

  • Over 10 years of experience in clinical operations, preferably in a biotechnology or pharmaceutical company
  • Proven track record of managing global clinical trials, including overseeing project timelines, budgets, and resources
  • Strong leadership and management skills, with experience in directing cross-functional teams
  • Excellent communication and interpersonal skills, with the ability to effectively manage relationships with external partners and internal stakeholders
  • Experience with regulatory compliance, including ICH/GCP and regulatory submissions
  • Strong analytical and problem-solving skills, with the ability to identify best practices and optimize operational efficiency
  • Bachelor's degree in a life science, business, or a related field
  • Professional certifications, such as CRO or CMO, are a plus
  • Experience with clinical trial management systems (CTMS) and electronic data capture (EDC) systems
  • Strong understanding of pharmaceutical regulations, including FDA guidelines and GMP requirements

Responsibilities

  • Oversee and direct relevant clinical operations resources
  • Contribute to strategy, tactics, and driving execution of multiple global clinical programs
  • Influence, oversee, and lead planning, budgeting, and study management processes in global clinical studies
  • Leads direct reports to successfully manage external service providers and internal cross-functional colleagues
  • Develop and implement department-level SOPs for clinical trials and related activities
  • Interface with departments within and outside of Clinical, including Finance, Regulatory Affairs, Legal Affairs, and Business Development
  • Represent the company at Investigator Meetings
  • Participate in clinical data review and submission activities
  • Develop training plans and conduct performance reviews for direct reports
  • Manage relationships with pharmaceutical partners and suppliers in clinical programs

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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