Director, Clinical Development, Medical Monitoring Lead at Abata Therapeutics

Boston, Massachusetts, United States

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

Versatile, self-motivated team player who thrives in a fast-paced collaborative environment
Ability to manage multiple projects concurrently
Excels at building relationships and trust with key stakeholders, particularly across nonclinical and clinical functions, as well as externally
Knows when to step in and lead and when to offer support

Responsibilities

Lead medical monitoring/reporting and safety activities in partnership with clinical sites and CROs
Act as the medical contact at the company for clinical/medical issues for ongoing studies
Interpret and report on results of clinical studies, in partnership with other internal study stakeholders for all phases of development
Participate or lead in safety review meetings and provide clinical input into adverse event evaluation and reporting
Support or when needed, lead, clinical program design activities, including planning, execution, and completion of clinical trials according to all applicable regulations and guidance, ICH/GCP, and Entrada SOPs
Partner with Clinical Operations to ensure all clinical study activities are completed in accordance with applicable regulations and guidance; ICH/GCP, and Entrada SOPs
Develop and maintain relationships with key opinion leaders and Principal Investigators
Provide management personnel with timely updates on progress and changes in scope, schedule, and resources as required
Ensure compliance with all applicable regulatory standards related to global clinical trials and interactions with physicians
Develop and maintain professional relationships with academic and community-based study sites involved in clinical development programs
Support clinical content of all clinical and regulatory documents, including protocols, INDs, CTAs, investigator brochures, CRF’s, annual IND reports, CSR’s, ISS’s, ISE’s, and clinical expert reports
Support relevant clinical advisory boards, data monitoring committees and medical/scientific meetings, including collaboration in preparation

Skills

Key technologies and capabilities for this role

Clinical DevelopmentMedical MonitoringRare DiseasesCross-Functional CollaborationStakeholder ManagementTherapeutic DevelopmentBiopharmaceuticalsOligonucleotide ProgramsDrug Delivery

Questions & Answers

Common questions about this position

What is the reporting structure for the Medical Monitoring Lead?

The role reports to the Sr. Vice President of Clinical Development.

Is this position remote or office-based?

This information is not specified in the job description.

What salary or compensation is offered for this role?

This information is not specified in the job description.

What key skills and qualities are needed for this position?

Candidates should be versatile, self-motivated team players who thrive in fast-paced collaborative environments, manage multiple projects, build relationships with stakeholders, and provide clinical leadership.

What is the company culture like at Entrada Therapeutics?

Entrada features a tight-knit team of experts in therapeutic development and rare diseases, with a high-energy, dedicated environment focused on getting things done to improve patients' lives.

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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