[Remote] Senior Director, Clinical Operations at Abata Therapeutics

Remote

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

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

Key technologies and capabilities for this role

Clinical OperationsClinical Trial ManagementRegulatory ComplianceICH/GCPPatient RecruitmentTrial Site SelectionTrial Plan OptimizationResource ManagementCross-functional Team Management

Questions & Answers

Common questions about this position

Is remote work allowed for this position?

Yes, the company is open to remote work for this role.

What is the salary or compensation for the Senior Director, Clinical Operations role?

This information is not specified in the job description.

What are the key skills or experiences required for this role?

The role requires experience in oversight of global clinical trials, leadership of cross-functional teams, management of CROs and vendors, strategic planning of clinical programs, and ensuring compliance with ICH/GCP regulations.

What is the company culture like at Dianthus Therapeutics?

The company is building a culture centered on core principles, continuous innovation, high scientific integrity, and elevating patient care, with an experienced team of biotech and pharma executives.

What makes a strong candidate for this Senior Director role?

Strong candidates will have proven leadership in global clinical operations, experience managing CROs and cross-functional teams, strategic planning skills for clinical trials, and a focus on compliance, efficiency, and patient impact.

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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