Phone: (267) 387-0090
Position Overview
Our client is a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need.
We are seeking an experienced biotech industry Clinical Scientist to support the scientific planning and execution of one or more clinical trials focused on COPD or asthma. This role involves working closely with cross-functional teams to design, implement, oversee and analyze clinical studies to advance the development of innovative dermatology therapies. The Clinical Scientist contributes scientific expertise and strategic insights to ensure the successful progression of clinical programs. This position reports to the Vice President of Clinical Development
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.
- 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 dermatology 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
Key Requirements
- 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 our client’s CORE values: Caring, Original, Resilient and Egoless
- Ability to travel approximately 15% to All Team meetings and functional meetings
Location(s)
If interested, please send a MS Word version of your resume to [email protected]
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