Director, Clinical Scientist

Summary

Join Apogee Therapeutics, a Nasdaq-listed biotechnology company, as a Clinical Scientist to contribute to the development of innovative respiratory disease therapies. This role involves designing, implementing, and analyzing clinical trials focused on asthma, collaborating with cross-functional teams, and ensuring regulatory compliance. You will play a key role in study planning, data analysis, and investigator collaboration. The ideal candidate possesses an advanced life science degree, extensive clinical development experience in the biotech/pharmaceutical industry (preferably respiratory), and strong analytical and communication skills. Apogee offers a competitive compensation and benefits package, including a base salary, performance bonus, equity grants, flexible PTO, and professional development opportunities.

Requirements

• Advanced degree in life science field (e.g., PhD, PharmD, or DVM)
• 5+ years’ experience working in clinical development within the biotechnology or pharmaceutical industry, preferably with a focus on respiratory
• Strong understanding of clinical trial design, execution, and data analysis
• Analytical mindset and ability to interpret complex scientific data
• Ability to manage multiple competing priorities with good planning, time management and prioritization skills
• Strong communication, technical writing, and presentation skills, with the ability to effectively convey scientific concepts to diverse audiences
• Proven ability to work in a cross-functional team environment
• Solid knowledge of Good Clinical Practice (GCP) and ethical guidelines governing clinical research
• Successfully exhibit Apogee’s C.O.R.E. values: C aring, O riginal, R esilient and E goless

Responsibilities

• Collaborate with cross-functional teams to develop clinical development plans and study protocols for respiratory-related trials with scientific rigor
• Contribute scientific input into the selection of appropriate endpoints, patient populations, and study methodologies
• Contribute to authoring and review of study documents
• Assist in site selection, investigator meetings, and study initiation activities
• Monitor the clinical trials, ensuring adherence to protocols, timelines, and quality standards
• Address and resolve scientific and operational challenges that arise during study conduct
• Collaborate with data management and biostatistics to develop data collection tools and ensure accurate and timely data capture
• Analyze clinical trial data, interpret results, and provide scientific insights to guide decision-making
• Contribute to the development of clinical study reports and scientific presentations
• Work with regulatory affairs to ensure that clinical trials are conducted in compliance with relevant regulations and guidelines
• Contribute to the preparation of regulatory submissions and responses to regulatory authorities
• Collaborate with pharmacovigilance to monitor and manage the safety of participants in clinical trials
• Participate in safety review meetings and contribute to the development of risk mitigation strategies
• Foster relationships clinical investigators to gather insights, address scientific questions, and promote collaboration
• Stay current with scientific literature and advancements in respiratory and related therapeutic areas
• Collaborate with clinical operations, medical affairs, regulatory affairs, biostatistics, and other teams to ensure alignment of clinical strategies with overall program goals

Preferred Qualifications

Experience in asthma and/or COPD

Benefits

• Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
• Flexible PTO
• Two, one-week company-wide shutdowns each year
• Commitment to growing you professionally and providing access to resources to further your development
• Apogee offers regular all team, in-person meetings to build relationships and problem solve