Vice President, Clinical Development – Remote
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 Vice President of Clinical Development.
Reporting to the Chief Medical Officer (CMO), the VP, Clinical Development role involves high level strategic planning as well as hands-on responsibilities to support the growing pipeline. This role will manage and lead a clinical development and operations team for the program portfolio, including programs at various stages in the development pipeline. This role will serve as the primary clinical lead for one or more clinical trials from protocol development through study execution to completion of study reports, working closely with cross-functional areas towards product registration. As Elevation Oncology continues to grow, this will open more leadership opportunities for this hire who will work closely with the company’s CMO, dedicated to mentoring and sharing in the overall strategic direction for clinical and pre-clinical assets.
- Develop strategic clinical development plans and oversee protocol design, execution, and data analysis/interpretation, in conjunction with other relevant functional leaders
- Manage, build, and lead a clinical development and operations team to execute and achieve functional responsibilities and program goals in compliance with GCP, ICH, and other global regulatory requirements
- Interface with global regulatory authorities, as appropriate, in support of the clinical development objectives; supports the completion and approval of study-related documents including for regulatory authorities, ethics committees, and other related study documents such as study reports
- Lead efforts to identify, build relationships and communicate with key investigators and trial sites to ensure successful execution of clinical studies in compliance with global regulatory requirements
- Direct study design, protocol development, and execution of clinical research for Phase 1 to 3 studies including pivotal cancer studies
- Contribute to the overall clinical strategy of the ongoing clinical development programs and product pipeline as well as giving in-depth clinical development advice on potential new projects (internal and external)
- Generate/review clinical components of key documents in support of regulatory submissions, including clinical section of IND’s and CTA’s, IND safety reports and annual reports for assigned trials, responses to regulatory authorities and Ethics Committees/IRBs, and other documents as appropriate
- Ensure quality of all clinical documents (e.g., Investigators’ Brochure, protocols, study reports, clinical components of regulatory submissions, safety related documents)
- Provide scientific clinical input to study-related documents and analysis plans including Informed consent forms (ICF), clinical research forms (CRF), statistical analysis plans (SAP), clinical pharmacology analysis plans (CPAP), and clinical study reports (CSR).
- Analyze and interpret data expertly, and clearly communicate results both internally and externally
- Act as primary Medical Monitor, monitoring the safety of enrolled subjects on assigned trials
Required Skills & Qualifications:
- Advanced degree in the biological sciences; MD preferred but not required
- 15+ years of clinical development experience in a biopharmaceutical or pharmaceutical company covering early and late-stage clinical trials
- Knowledge and understanding of early and late phase clinical trial design and global regulatory requirements for study execution
- Experience with GCP/ICH/FDA requirements, clinical trial design and strategies, interpretation of clinical data and generation of supporting regulatory submissions of clinical study documents
- Clinical development experience within oncology/malignant hematology is strongly preferred
- Demonstrated ability to represent the Company in a variety of internal and external settings
- Ability to develop and maintain relationships with significant key opinion leaders and thought leaders
- Experience managing physicians and/or scientific staff in a management or team leader capacity highly desirable
- Exceptional interpersonal, influencing, presentation, and written and verbal communication skills
- Trustworthy with highest integrity; committed to ethics and scientific standards
- Ability to prioritize, respond to directives, and work in a fast-paced and changing environment remotely
- Get-it-done-roll-up-your-sleeves attitude and committed to putting patients first
- Must be located within and authorized to work in the United States today and in the future.
25-50% domestic and international travel will 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 email@example.com 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.
Search Firms and Agency Representatives: Elevation Oncology is not accepting unsolicited resumes from search firms or agencies for any job posting. Resumes submitted to any employee of Elevation Oncology by any search firm or agency without an applicable contract in place will be the property of Elevation Oncology and no fee will be paid.