Medical Director, Clinical Development - Dermatology/Immunology

Role Summary

We are seeking a Medical Director to oversee clinical execution and medical monitoring of dermatology studies. As part of a growing clinical development team, you will be responsible for seamless execution of studies and supporting the cross-functional development team in forming the clinical strategy with a focus on protocol development and execution, and medical monitor activities. If you thrive in a fast-paced environment and seek the opportunity to advance clinical programs into later stages of development this role is for you!

Responsibilities

• Serve as a 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 Medical Monitoring Plan
• Support the design of trials and develop protocols and other relevant documents for individual studies
• Support all the start-up activities related to the assigned dermatology clinical study
• Oversee day-to-day clinical and medical execution of studies
• 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 clinical operations on site selection, recruitment, and CRO management
• Partner with medical affairs to build and maintain strong relationships with PIs, including support of Advisory and Scientific Boards
• Serve as primary medical point of contact for sites and PIs for the assigned study, as applicable

Qualifications

• Education ‚Äì MD is required
• Experience in clinical development within the Immunology & Inflammation therapeutic areas, ideally dermatology, allergy or rheumatology
• 2+ years‚Äô industry experience as a medical monitor and/or medical director
• Experience working on phase 2 and 3 clinical studies required
• Highly motivated team player with a growth mindset, can-do attitude and willing to learn from others
• Effective communication skills with an ability to present to a variety of stakeholders and tailor message accordingly
• Successfully exhibit Apogee‚Äôs C.O.R.E. values: Caring, Original, Resilient and Egoless
• Ability to travel approximately 15% to All Team meetings, functional meetings, study-related activities, and medical conferences

Skills

• Clinical development strategy and protocol development
• Medical monitoring and safety signal management
• Cross-functional collaboration (clinical operations, regulatory, biostatistics, data management)
• Site and CRO management
• Relationship building with PIs and advisory boards

Education

• MD required

Additional Requirements

• Travel approximately 15% as needed