Senior/Medical Director, Oncology at Abata Therapeutics

New York, New York, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, OncologyIndustries

Requirements

MD, MD/PhD, or equivalent degree, Board Eligible or Certified in Medical Oncology
1+ year of industry experience in a medical monitor/medical director role overseeing oncology clinical program(s). Additional experience running clinical trials as clinical site study investigator is highly preferred
Understanding of the drug development process from target identification to marketing authorization
Strong knowledge of ICH, GCP guidelines, and relevant regulatory requirements
Excellent written/verbal communication, organizational, and problem-solving skills
Based in NYC and requires weekly in office presence, 2-3 days per week

Responsibilities

Work collaboratively with the entire clinical organization to drive the strategy and execution of the overall clinical development plans of the company
Support the design of clinical trials and contribute to writing medically important documents such as protocols, regulatory documents, and study reports
With support from clinical science and consultant/CRO partners, provide medical oversight of clinical trials, including medical monitoring, review of important safety events, and appropriate communications with investigators
Build and maintain strong relationships with clinical study investigators and other external partners
Work closely with translational sciences to ensure successful clinical biomarker plans for assigned clinical studies
Ensure compliance with SOPs, GCP, safety reporting, and other applicable regulations
Travel to critical medical conferences (<10% travel)

Skills

Key technologies and capabilities for this role

OncologyClinical DevelopmentClinical TrialsDrug DevelopmentTrial PlanningTrial ExecutionTrial Analysis

Questions & Answers

Common questions about this position

What is the salary for the Senior/Medical Director, Oncology role?

This information is not specified in the job description.

Is this role remote or does it require office presence?

The job is based in NYC and requires weekly in office presence, 2-3 days per week.

What skills and experience are required for this position?

The ideal candidate works collaboratively, leads by example, is detail-oriented and self-motivated, and has highly relevant experience in oncology clinical development.

What is the company culture like at Volastra Therapeutics?

Volastra is a fast-paced biotech company of passionate employees with ample opportunity for growth and development, including experience with projects outside direct scope.

What makes a strong candidate for this role?

A strong candidate has highly relevant experience in oncology clinical development, works collaboratively, leads by example, and is detail-oriented and self-motivated.

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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