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Apogee Therapeutics · 1 day ago

Medical Director, Clinical Development – Dermatology

United States

Full-time

Remote

Mid, Senior Level

$270K/yr - $310K/yr

2+ years exp

Apogee Therapeutics is a biotechnology company seeking to develop differentiated biologics for the treatment of various inflammatory and immunology indications. The Medical Director will support clinical execution and medical monitoring of dermatology studies, ensuring seamless study execution and contributing to the clinical strategy.

BiotechnologyLife ScienceMedicalTherapeutics

Responsibilities

Serve as a primary Sponsor medical representative for assigned clinical trial, working closely with the CRO medical monitor and cross-functional partners, and pharmacovigilance on study execution including but not limited to safety reporting, escalation for medical issues, development and execution of the Medical Monitoring Plan

Contribute to protocol development, study documents, operational plans, and other relevant documents for individual studies

Support all the start-up activities related to the assigned Dermatology clinical study including investigator training, vendor discussions, cross-functional team reviews

Oversee day-to-day clinical and medical execution of studies including direct medical review of eligibility, safety events, and clinical data

Work closely with cross-functional colleagues, including, but not limited to regulatory, biostatistics, and data management, to ensure timely and flawless execution of clinical plan and study milestones in alignment with business goals

Partner with clinical operations on site selection, recruitment, site relationship management and CRO management

Partner with medical affairs to build and maintain strong relationships with PIs by participating in KOL interactions and scientific engagement activities

Qualification

MDDermatologyClinical developmentStudy designPhase 23 studiesEffective communicationTeam playerGrowth mindset

Required

MD is required

Experience in clinical development and/or study design and execution within the Immunology & Inflammation therapeutic areas, ideally dermatology, allergy or rheumatology

2+ years' pharma/biotech clinical development or medical affairs with study execution experience

Effective communication skills with an ability to present to a variety of stakeholders and tailor message accordingly

Successfully exhibit Apogee's C.O.R.E. values: Caring, Original, Resilient and Egoless

Preferred

Dermatologist strongly preferred

Experience working on phase 2 and 3 clinical studies strongly preferred

Highly motivated team player with a growth mindset, can-do attitude and willing to learn from others

Benefits

Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits

We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave

Commitment to growing you professionally and providing access to resources to further your development