Vice President, Clinical Development at Abata Therapeutics

San Diego, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

MD or DO with a subspecialty in Oncology, specifically in the treatment of genitourinary cancers is required
Successful completion of post-graduate training or residency in Oncology, along with board certification or board eligibility is highly desirable
Minimum 8 years of experience within biotechnology, pharmaceutical or relevant academic institutions required
Expert level understanding of early drug development and clinical trial processes with a track record of leading clinical development programs is essential
Knowledge of GCP and ICH guidelines and regulatory requirements for the conduct of Oncology clinical trials, particularly in the treatment of prostate cancer
Strong ability to critically evaluate data, literature, and presentations
High level of communication skills is expected

Responsibilities

Provide strategic oversight and direction for one or more clinical trial programs, ensuring alignment with organizational goals and regulatory requirements
Lead the design, development, and implementation of clinical trial strategies and plans in partnership with Pre-clinical R&D, Clinical Operations, Regulatory Affairs, Quality Assurance, and Janux’s Management Committee
Oversee the execution of clinical development programs, including protocol development, data interpretation, and decision-making at key program milestones
Serve as a source of medical expertise and provide high-level guidance to cross-functional teams, clinical project staff, and investigative sites
Perform the duties of a Medical Monitor as needed to ensure clinical integrity and patient safety, while delegating operational aspects where appropriate
Provide subject matter expertise and medical review and/or input within the preparation of medical components of clinical trial and regulatory documents
Contribute to CRO, clinical site and investigator training; actively interact with CROs, clinical sites and investigators regarding study implementation
Respond to clinical questions from sites, IRBs/IECs, Health Authorities and CROs
Review, interpret and present clinical data to both internal and external key stakeholders
Establish and maintain relationships with KOL’s, medical experts and investigators in the area of Immuno-Oncology and more importantly, within the genitourinary disease areas

Skills

Clinical Trial Leadership

Clinical Strategy

Data Interpretation

Regulatory Requirements

Protocol Development

Medical Monitoring

Medical Expertise

Clinical Development Plans

Clinical Study Reports

Investigator Brochures

SAE Narratives

INDs

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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