Medical Director, Clinical Development

Remote

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Pharmaceuticals, Clinical ResearchIndustries

Requirements

Candidates should possess a Medical Degree (MD or DO) with board certification in Internal Medicine or a related specialty, and a minimum of 8 years of experience in clinical development, with at least 5 years in a leadership role within the pharmaceutical or biotechnology industry. Strong knowledge of clinical trial design, regulatory requirements, and data analysis is essential, along with demonstrated experience in overseeing clinical studies and collaborating with cross-functional teams.

Responsibilities

The Medical Director, Clinical Development will support the development of clinical trial protocols, oversee the conduct of clinical trials at study sites, ensure adherence to protocols and good clinical practice (GCP) guidelines, review and interpret clinical data to assess the safety and efficacy of the investigational drug, and author clinical and non-clinical documents required during the clinical development process. They will also provide medical expertise of the therapeutic area, disease state, and potential drug effects, review clinical data to identify and analyze safety concerns and adverse events, and stay current with relevant medical literature and regulatory guidelines.

Skills

Clinical Trial Design

Protocol Development

Data Analysis

Good Clinical Practice (GCP)

Safety Monitoring

Regulatory Documentation

Medical Expertise in Dermatology/Inflammatory Diseases

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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