Abata Therapeutics

Therapeutic Area Head - Clinical Development – Dermatology

Remote

Not SpecifiedCompensation
Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Biotechnology, PharmaceuticalsIndustries

Position Overview

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Apogee Therapeutics, Inc. is a well-funded, Nasdaq-listed biotechnology company founded in 2022. We are seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease, and other inflammatory and immunology indications with high unmet need. Our antibody programs aim to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering. We are committed to building an exceptional company culture founded on our C.O.R.E. values: Caring, Original, Resilient, and Egoless.

Role Summary

We are seeking a Therapeutic Area (TA) Head - Clinical Development. This newly created position is primarily responsible for developing and executing an integrated clinical development strategy and clinical trial programs in dermatology. This leadership role offers the opportunity to guide and mentor a team of experienced Medical Directors and Clinical Scientists. You will provide clinical expertise, obtain scientific advisory input from external experts, work cross-functionally to develop clinical studies, lead clinical aspects of regulatory interactions, and partner with the clinical operations team to provide medical and strategic input for operational excellence. The TA Head will have expertise in dermatology and/or immunology, demonstrated collaborative skills across various phases of clinical development (emphasis on Phase 2 and beyond), and serve as a medical expert for multiple cross-functional teams. Building relationships with investigators, including meeting with sites for collaboration and training, is essential. The TA Head will oversee programs across the dermatology portfolio and reports to the SVP, Head of Clinical Development.

Requirements

  • Expertise in the treatment and management of dermatological conditions.
  • Demonstrated effective collaborative skills to work across various phases of clinical development with an emphasis on later stages (Phase 2 and beyond).
  • Serve as a medical expert for multiple cross-functional teams.
  • Building relationships with Investigators is essential for this role.

Responsibilities

  • Lead and mentor a team of experienced Medical Directors and Clinical Scientists focused on bringing innovative treatments to patients.
  • Apply expertise in the treatment and management of dermatological conditions to advance the strategy and clinical development of Apogee’s medicines for the benefit of our patients.
  • Work cross-functionally with Program Leadership/Management, Clinical Strategy Office, Biometrics, Medical Affairs, Clinical Pharmacology, Regulatory Affairs, Research & Translational Medicine, Commercial, and other functions to develop the overall clinical development strategy in dermatologic indications.
  • Collaborate with Clinical Operations, Biometrics, Pharmacovigilance, and other functions to execute and successfully complete clinical trials across development phases leading to BLA filings and approvals.
  • Help establish and maintain a network and relationships with dermatology experts, investigators, and opinion leaders.
  • Contribute to the scientific communication strategy of Apogee Therapeutics via publications, manuscripts, abstracts, posters, and scientific presentations.
  • Participate in medical review of adverse events.

About Apogee Therapeutics

Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics, Inc. is a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need. Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless. If this sounds like you, keep reading!

Skills

Clinical Development
Medical Leadership
Regulatory Strategy
Clinical Trial Design
Team Mentoring
External Scientific Advisory

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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