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 Medical Director. Title and compensation will be based upon the experience and qualifications of the selected candidate.
This position involves both high level strategic planning as well as hands-on responsibilities to support the growing pipeline. Reporting to the Chief Medical Officer (CMO), you will serve as the primary medical lead for one or more clinical trials, working with cross-functional study teams on clinical trial strategy, design and execution. You will be accountable for the medical oversight of the trial(s), medical data review and communication of data, and medical input into regulatory documents and presentations. As Elevation Oncology continues to grow, this will open up more leadership opportunities for this hire who will work closely with the company’s CMO, dedicated to mentoring and sharing in overall strategic planning for clinical and pre-clinical assets.
- Lead efforts to identify, build relationships and communicate with key investigators and trial sites to ensure successful enrollment of the right patients
- Direct study design, protocol development and execution of clinical research for pivotal cancer studies
- Contribute to the overall medical strategy of the assigned clinical development programs and product pipeline as well as giving in-depth medical 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 and medical 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:
- Medical degree (MD, MBBS) and relevant experience (including academia)
- At least 5 years of clinical development experience in a biopharmaceutical or pharmaceutical company covering early and late-stage clinical trials
- Clinical development experience within oncology/malignant hematology is strongly preferred
- Demonstrated ability to represent the Company in a variety of internal and external settings
- 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
- 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
- Get-it-done-roll-up-your-sleeves attitude and committed to putting patients first
- Ability to develop and maintain relationships with significant key opinion leaders and thought leaders
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 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.