Description

The Senior Medical Director, Clinical Development is a very hands-on role supporting 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 plays a critical role in partnering with the SVP, Clinical Development 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 clinical programs. The successful candidate will also provide research into strategy and competitive oncology landscape.

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. This is a remote-based position located in the United States.

Responsibilities:

• Internal SME, Clinical program oversight; medical monitoring of one or more clinical trials; review and interpret clinical trial data
• Author and review 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, 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 strategies 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., conferences, 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
  
  

Requirements

• MD or DO required with 3+ years’ experience in clinical development, with a combination of experience in small and large pharma as well as previous bedside care preferred
• Proven strategic management experience demonstrating business acumen, developing and delivering strategy and vision, delivering results, championing innovation, coaching and developing subordinates including remote teams
• Experience in solid tumor oncology preferred, exceptional experience in other therapeutic areas will be considered if the candidate demonstrates clear potential to apply their existing skills to Oncology
• Direct experience in co-authoring IND, IB, NDA, (s)NDA, and/or MAA, CSRs, abstracts, manuscripts
• Global clinical trial experience, mid-late stage, and post-commercial studies is preferred
• Extensive knowledge of clinical drug development, with deep oncology experience, including FDA regulations, GCP, statistics, safety, HIPPA rules, etc.
• Experience in working with small molecule and biologics is preferred
• Understanding of drug safety and pharmacovigilance and biostats related to clinical trial design
• Travel up to 20% based on company needs
• Ability to demonstrate Elevar’s core values by holding ourselves and each other accountable for the work we do, taking time to collaborate effectively while working remotely, making space for ingenuity in work and thought, and staying grounded in compassion
  
  

The anticipated annual base salary range for this role is $300,000 to $345,000. Final compensation depends on multiple factors including but not limited to, relevant experience, skillset, depth and breadth of knowledge, internal equity, and external market factors. Elevar Therapeutics is a rapidly growing biotech company that offers competitive wages and benefits package including medical, dental, vision, time off, a retirement plan, and other voluntary benefits for employees.