The Senior Medical Director, Clinical Development will support Elevar assets by successful execution of clinical development programs and deliverables in partnership across the organization including cross-functional teams, external vendors, academicians, and collaboration partners and play a critical role in partnering with the Chief Medical Officer (CMO) in defining the clinical strategy for the company. The successful candidate will provide medical and clinical program input on strategy, design, execution, and interpretation of data from late-stage clinical solid tumor programs. The successful candidate will also provide research into strategy and competitive landscape for various assets in the oncology-hematology-immumo/oncology space.
This individual will be responsible for ensuring that all studies under her/his purview are conducted with the highest level of ethical and safety standards and follow GCP and all regulatory policies. Duties include primary interactions with investigators, CROs, other vendors, and development partners, functioning as the medical representative on the integrated project team, and providing medical consultation as needed across the Elevar portfolio of products and studies.
A genuine interest and understanding of the science, desire to work in a highly collaborative organization and deep passion for making a difference in patients’ lives are essential. This is a remote-based position.
- Medical monitoring of one or more clinical trials; review and interpret clinical trial data; medical review of eligibility data
- Author and review of key documents including but not limited to protocol synopsis, protocols, amendments, medical development plan, IB, ICFs, CSRs, CRFs, abstracts, posters, manuscripts, clinical section of INDs, NDAs, MAAs, annual reports, DSURs, clinical narratives, Regulatory Packages, Briefing Documents, Clinical Development Plans, Data queries, and others
- Provide oversight and medical accountability for the company’s clinical trials
- Evaluate scientific information and new ideas to assist in identifying new research opportunities
- Secure, analyze, and report on competitive intelligence related to successful conduct/execution of studies sponsored by other organizations and new data that may impact Elevar programs
- Responsible for resourcing assigned clinical development programs within functional area;
contribute to CDP for one or more assets
- Represent clinical development to KOLs, investigators, and regulatory agencies
- Present findings internally and externally (e.g., investigator meetings, regulatory agency meetings) acting as a spokesperson for Elevar; contribute to determining global strategy for development of oncology assets
- Work cross-functionally with clinical operations, biometrics and data management, drug safety, regulatory, clinical pharmacology, medical affairs, etc.; successfully interface with development partners
- Prepare manuscripts, abstracts, and presentations for scientific meetings
- MD (or equivalent) required with 5+ years’ experience in Oncology clinical development, with experience in small and large pharma. Candidates with exceptional experience in other therapeutic areas will be considered if they demonstrate clear potential to apply their existing skills to Oncology.
- Training in Oncology required; US fellowship and board certification preferred
- Those without an MD or DO, with a Ph.D. or PharmD, may be considered for a Clinical Science title
- Direct experience in co-authoring IND, NDA, (s)NDA, and/or MAA
- Global clinical trial experience, including Phases 1 through 3 studies
- Extensive knowledge of oncology clinical drug development, including FDA regulations, GCP, statistics, safety, HIPPA rules, etc.
- Experience in working with small molecule targeted agents; experience with VEGFR inhibitors a plus
- Excellent written and verbal communication skills
- Willing and able to travel, as needed