Medical Director, Clinical Development

Astria Therapeutics - Boston, MA

Full-time - Senior

Hybrid - Boston, MA

Chemical Manufacturing

About the position

Astria Therapeutics is dedicated to bringing hope with life-changing therapies to patients and families affected by allergic and immunological diseases. Astria's pipeline includes our lead program, Navenibart, a monoclonal antibody inhibitor of plasma kallikrein in clinical development for the treatment of hereditary angioedema, as well as STAR-0310, an OX40 monoclonal antibody antagonist currently in pre-clinical development for atopic dermatitis (AD) and being explored for other allergic and immunological diseases. Astria is seeking a creative individual who is driven by patients and science to advance our pipeline. The Medical Director, Clinical Development will report to the VP, Late Clinical Development and be responsible for supporting clinical development, functioning as the medical lead and Astria medical monitor for clinical trials, and working with cross-functional multidisciplinary study teams on clinical trial strategy, design, and execution. The ideal candidate will have deep expertise in immunology and dermatology (rendering a thorough understanding of target and disease biology), as well as experience as a medical monitor in early- to late-stage clinical trials.

Responsibilities

• Provide medical, disease-specific, and development perspective into specific research programs or broader research initiatives
• Support the design of trials and develop protocols, Investigational Brochures, and other key study documents in conjunction with other functional areas; ensure alignment of protocols across a program
• Support start-up activities (informed consent forms, eCRF design, etc.) related to the assigned clinical studies
• Serve as Astria medical monitor, working closely with the CRO, clinical operations, and pharmacovigilance on study execution including but not limited to safety reporting, point of escalation for medical monitoring matters, development and execution of the CRO Medical Monitoring Plan
• Work closely with cross-functional colleagues, including, but not limited to, clinical operations, regulatory, biostatistics, and data management, to ensure timely and flawless execution of clinical plan
• Partner with medical affairs to build and maintain strong relationships with PIs, including support of Advisory and Scientific Boards
• Serve as primary Astria medical point of contact for sites and PIs for the assigned studies, as applicable

Requirements

• Ability to work a hybrid schedule of 2-3 days a week in our Boston office
• MD / DO or equivalent
• 2+ years' clinical experience in dermatological immune-mediated / inflammatory diseases (dermatology, allergy, or immunology trained - residency or fellowship)
• 2+ years' experience as a medical monitor and/or medical director
• Experience designing mid- and late-phase clinical trials and comfortability with advanced clinical trial design and statistical methodologies
• Experience with execution and analysis of clinical trials
• Capable of analyzing research data and publications; working knowledge of biostatistics; working knowledge of GCP, scientific and clinical research methods and clinical study design
• Highly organized, outcome-oriented, self-motivated performer; demonstrates creativity, determination and ownership
• Team player with a growth mindset, can-do attitude and willingness to learn from others
• Effective oral and written communication skills with an ability to present to a variety of stakeholders and tailor message accordingly
• Excellent interpersonal skills, ability to develop important relationships with key stakeholders across a variety of disciplines, good conflict management and negotiation skills
• Ability to travel up to 15%, domestic and international