Clinical Scientist, Lead
Location: Remote, Experience: 8+ years, Type: Full-time Exempt
Reports to: Sr. Vice President, Therapeutic Area Neurology/Chronic Disease
Vaxxinity, Inc. is a U.S.-based, clinical stage biotechnology company, that aims to democratize health by bringing the efficiency of vaccines to chronic diseases. Vaxxinity has a proprietary technology platform that enables the innovation of synthetic peptide vaccines designed to treat and prevent chronic diseases, including Alzheimer’s, Parkinson’s, migraines, and hypercholesterolemia, as well as infectious diseases, including COVID-19. Vaxxinity has designed its pipeline to achieve a historic global impact on human health. Vaxxinity has locations in New York City, NY and Merritt Island, Florida and offers employee remote work opportunities.
You will collaborate with a group of inspiring colleagues who are working on disruptive projects, solving big problems, and having a huge impact on the world. Be science driven; communicate clearly, openly, and respectfully; unite in teams and collaborations; learn and help others learn; act with integrity and get sh*t done. Expect to grow, expect to be challenged, and expect the unexpected as we embark on this journey of democratizing health for all the world’s citizens.
We are searching for a polished, smart, passionate, caring, self-motivated Clinical Scientist, Lead. The ideal candidate brings wisdom, enthusiasm, integrity, focus and perspective to assist TA Head and or Study Physician, and study team with the clinical/scientific conduct of clinical studies e.g., adjudication support, medical monitoring, imaging data reconciliation, preparation of meeting materials, protocol deviation management; may support a single study or multiple studies; may lead a study with limited scope (e.g., Survival Follow-up); and may interact with internal and external stakeholders (study sites, committees, etc.) in support of clinical study objectives. The Clinical Scientist Lead is involved in the design, monitoring, and data analysis of the Company’s early phase clinical trials studying neurological and or/chronic therapies. As such, the Clinical Scientist Lead is an important and visible member of the Clinical Development Team.
Responsibilities (duties are not limited to the below and may evolve over time depending on business needs and individual expertise).
- Instrumental role in the creation of Clinical Development Plans for the assigned Neuro/Chronic Disease areas
- For clinical trials: design, provide oversight, and support site and subject retention
- Ensure successful completion of documents (including input and creation of clinical trial protocols, investigator brochures. Working collaboratively with Clinical operations in monitoring plans, site training materials, clinical study reports, health authority responses, stand operating procedures, etc. with cross-functional team members
- Participate on study teams and cross-functional teams as appropriate, and as delegated by the Sr. Vice President, Clinical Development Neurology Chronic Diseases
- Ensure consistent use of language and criteria across multiple neurology/chronic disease assigned projects
- Ensure study integrity and track accumulating safety and efficacy data
- Anticipate obstacles within a clinical trial, and implement solutions
- Analyze, evaluate, and support accurate interpretation and reporting of clinical data
- Contribute and create clinical documents, manuscripts, presentations, and regulatory submissions
- Maintain up-to-date knowledge of relevant science, medical information, good clinical practices, and regulatory guidance
- Collaborate with and serve as a clinical research resource for cross-functional colleagues to optimize product development
- Cultivate relationships with investigative sites, clinical consultants, and key opinion leaders to represent the interests of the company
- Support corporate strategic and organizational initiatives
- Assist with business development activities as needed
- Complete assigned tasks thoroughly, accurately, and on time
- Adhere to rigorous ethical standards
- Travel up to 30% domestically and international for scientific meetings
Education / Experience
- BA/BS/MS/Ph.D. in Life Sciences
- 8+ years relevant Clinical Research experience
- At least 8 years of experience with clinical trial design and execution preferred
- At least 8 years of pharmaceutical industry experience in Clinical Development preferred
- Project Management Certification preferred
- Early phase pharmaceutical and clinical drug development experience in a Clinical Scientist or equivalent role as a lead preferred
- Proven ability to effectively manage multiple complex studies
- TA specific experience in Neurology and/or rare disease is beneficial
- Excellent Excel and PP skills required
- Excellent written and oral communication skills
- Excellent Project Management skills
Knowledge / Skills / Abilities
- Strong track record of scientific and clinical inquiry
- Understand statistical concepts and clinical trial design
- Understand the connection between nonclinical data and clinical data
- Possess excellent communication skills (both written and verbal)
- Learn quickly, follow complex directions under pressure
- Multi-task while remaining organized and attentive to detail
- Work hard, be a trustworthy and collaborative team player
- Take initiative and solve problems of moderate complexity
- Demonstrate sound judgement in terms of handling complex, confidential and regulated information
- IND/NDA/BLA filing experience
- Experience with regulatory submissions and interactions
- Lead both directly and by example
- Flexibility to function well within a team environment and within condensed timelines
- Capacity to complete tasks independently
- Ability to stay calm, cool, and focused in stressful times and maintain a professional demeanor.
- Excellent project management and prioritization skills including ability to handle multiple tasks and work in a fast-paced, time-sensitive environment.
- Proven high level capability to concisely communicate complex and controversial issues and drive to resolution.
- Demonstrated capability and passion for developing talent and a culture of innovation, collaboration and engagement.
- Ability to influence decision making with or without authority, facilitate groups with diverse perspectives, across geographies, and bring teams to agreement.
- Humility and the belief you can make the world a better place is highly desired.