Clinical Research Science Lead
It takes a team to reach the summit.
Join us to build a future in which each patient has access to the right physicians, the right tests, and the right therapeutics to treat their individual tumor.
Elevation Oncology, a clinical stage biopharmaceutical company focused on the development of precision medicines for patients with genomically defined cancers has an opening for an experienced Clinical Research Science leader. Title and compensation will be based upon the experience and qualifications of the selected candidate.
Together with the Chief Medical Officer (CMO) and in collaboration with the Elevation Oncology clinical research and clinical operations teams, the primary role is to deliver early/late-stage clinical trials in patients with cancer. The individual in this role will be a key member of the Clinical Development team, supporting activities associated with the design, execution, and reporting of clinical studies.
- Independently writes/designs protocol outlines, protocols, and amendments of moderate complexity in collaboration with the Clinical Lead, Clinical Operations, and other relevant groups
- Co-lead and oversee clinical development/authorship of informed consent forms, eCRFs, study manuals, clinical study reports, and regulatory submission documents
- Contribute to abstracts and publications that evolve from clinical trial data
- Site-facing activities such as training and serving as primary contact for clinical questions
- Review Clinical data to identify trends, provide updates to key stakeholders and target questions to the CMO
- Review development of site and CRA training materials and presentation at SIV and Investigator meetings and support on Study committee (e.g., DMC) activities
- Work with Clinical Operations to provide oversight of CRO/study vendors’ performance as it relates to study start-up and conduct
- Interact with clinical investigators and Key Opinion Leaders as appropriate
- Work closely with Clinical Operations to track study recruitment and implement action plans to address early impediments to study enrollment
- May act as medical monitor for company sponsored trials
- Conducts medical monitoring reports, safety reviews, site interactions, and reviewing TFLs
- Other responsibilities as agreed upon
Required Skills & Qualifications:
- Advanced degree such as a Masters, PharmD, PhD
- Three years or more of clinical development experience in biotechnology or pharmaceutical industry
- Hands-on experience in the design, execution, and reporting of controlled clinical trials in oncology
- Participated in clinical oncology studies with a biomarker defined population is an advantage
- Experience interpreting clinical data and generation of supporting regulatory submissions of clinical study documents
- Ability to prioritize, respond to directives, work independently with minimal supervision, and perform in a fast-paced and changing environment remotely
- Ability and strong desire to “make things happen”. Must have a results-oriented work ethic and a positive, can-do attitude
- Strong interpersonal, influencing, presentation, and written and verbal communication skills
- Strong organizational and time management skills
25-50% domestic and international travel may be required
Life at Elevation Oncology
Our values lay the foundation for the road ahead:
INTEGRITY: We’re committed to identifying and targeting the genomic targets that can make the most meaningful difference to a patient, no matter how rare. Each tumor is unique, and every patient deserves access to a drug that is made with their tumor in mind, whether made by Elevation Oncology or an industry peer.
COMMUNITY: We celebrate the unity in our shared mission and the diversity of our strengths both as individuals in a team, and as a company in a vibrant precision medicine community. We actively seek and nurture effective collaborations and strive to be a trustworthy corporate citizen.
ADVOCACY: We advocate for the widespread adoption of genomic testing and a cooperative effort supporting patient awareness and education. We believe that only as a unified industry can we can best provide our patients with a clear path forward.
If you share our beliefs and are interested in helping to further our mission, send your resume or CV to firstname.lastname@example.org and tell us how you can help. We look forward to meeting you!
Elevation Oncology is an equal opportunity employer and encourages applications from all individuals.