Director, Clinical Scientist - Respiratory
We are seeking an experienced biotech industry Clinical Scientist to support the scientific planning and execution of one or more clinical trials focused on asthma. This role involves working closely with cross-functional teams to design, implement, oversee and analyze clinical studies to advance the development of innovative respiratory disease therapies. In addition to day to say study management in collaboration with the medical monitor, the Clinical Scientist also contributes scientific expertise and strategic insights to ensure the successful progression of clinical programs.
Key Responsibilities
Clinical Study Design and Planning:
- 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
Protocol Implementation and Oversight:
- 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
Data Collection and Analysis:
- 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
Regulatory Compliance:
- 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
Safety Monitoring and Risk Management:
- 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
Investigator Collaboration:
- Foster relationships clinical investigators to gather insights, address scientific questions, and promote collaboration
Scientific Literature Review:
- Stay current with scientific literature and advancements in respiratory and related therapeutic areas
Cross-Functional Collaboration:
- Collaborate with clinical operations, medical affairs, regulatory affairs, biostatistics, and other teams to ensure alignment of clinical strategies with overall program goals
Ideal Candidate
- Advanced degree in life science field (e.g., PhD, PharmD, or DVM)
- Must have 5+ years’ experience working in clinical development within the biotechnology or pharmaceutical industry, preferably with a focus on respiratory; experience in asthma and/or COPD highly desired
- 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: Caring, Original, Resilient and Egoless
- Position requires approximately 15% travel to All Team meetings and functional meetings
The anticipated salary range for candidates for this role will be $200,000 to $250,000 per year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.
- A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless
- Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
- 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
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