Everlywell
EverlyWell provides consumer-initiated at-home laboratory testing with easy-to-read and actionable results. We are at the forefront of personalized health, transforming the $25B lab testing industry. We’re here to empower people to take control of their health by making lab testing easy to access, understand, and afford.
ROLE SUMMARY
The Head of Clinical Science will be responsible for overseeing the company’s global clinical research and development organization and all clinical trial programs from early phase testing through Phase III and/or on-market products. He or she will oversee all clinical research activities including development of clinical trial protocols, site selection, accrual strategies to meet enrollment goals, data management strategies and input into regulatory filings to gain product approval. They will participate in team efforts to develop critical regulatory submissions. They will develop functional plans for managing clinical research activities to be performed in-house or through third party relationships and will manage overall operation of clinical studies including supervision of project planning, budget and resource management. The Head of Clinical Research and Development will oversee clinical trial operations staff and manage all aspects of the clinical operation plan. He or she will be responsible for managing the full scope of study protocol and scientific aspects, including natural history studies, and studies required for validation of novel endpoints, as well as additional oversight for biostatistics, drug safety and medical writing.
We are in high growth, startup mode and need someone who is willing to get their hands dirty. If you are passionate about life sciences and looking for an opportunity to learn, build, optimize, and grow, EverlyWell is the place for you.
What You’ll Do:
- Direct and oversee the design and implementation of clinical projects, as a member of the company’s LCM leadership team
- Ensure that the overall scientific and medical content of all clinical programs is sound
- Ensure the integration of pre-clinical and early clinical findings with planned clinical programs
- Work to secure cross functional alignment and/or transparent discussion of risks associated with clear plans to further investigate and track through clinical development
- Provide oversight for the clinical protocol team including interactions with discovery, safety, marketing, patient advocacy, regulatory, research and other functions
- Participate on and/or provide oversight for clinical study team activities, including asset teams, clinical subteams, clinical project teams and third party external vendor (CRO) teams
- Prepare clinical development plans and create/institute properly approved clinical protocols
- Design scientifically rigorous and cost effective clinical development programs
- Working with biostatisticians, lead data analysis of clinical findings
- Prepare and/ or review various official and regulatory documents, such as BLAs, for regulatory and other agencies
- Work with team members to prepare abstracts manuscripts and presentations for external meetings as well as author clinical sections of regulatory documents
- Serve as/or appoint a medical monitor responsible for the safety monitoring of clinical trials and as medical expert for studies, managing the process from protocol development through individual study reports and integrated regulatory documentation
- Contribute and support clinical initiatives to improve the quality and content of all clinical programs as well as the cross-functional/organization process designed to effectively deliver our R&D portfolio
- Manage lifecycle requirements and plans for company products
- Effectively manage, mentor and develop clinical development and clinical operations personnel
Experience & Education:
- Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements
- Prepared for and participated in multiple regulatory authority meetings including product approval and post approval meetings in multiple jurisdictions
- Ability to provide scientific and clinical expertise to a clinical development program and evaluate scientific and clinical strategies for a product
- Advanced understanding of clinical medicine, clinical pharmacology, and associated disciplines (eg, biostatistics) drug development principles; demonstrated experience in all developmental phases, including evaluation of non-clinical data
- Experience with designing and running multiple clinical trials; able to speak to the strategy of the clinical development plan
- Demonstrated ability to manage and motivate internal and external team members
- Strong written communication and presentation skills
We Love Working Here:
- Venture backed by top-tier firms
- The opportunity ahead knows no bounds
- Open vacation policy
- Employee discounts
- Paid parental leave
- Health benefits
- 401(k)
EverlyWell is committed to providing equal employment opportunities in all employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship status, marital status, age, disability, protected veteran status, sexual orientation or any other characteristic protected by law.
HIPAA Disclaimer: This role will be in an environment that has access to protected health information (PHI) and all security standards to protect PHI must be followed.