10 months ago
Exciting opportunity to join a mid-size biotechnology company on the cutting edge of muscular disease therapies. Reporting directly to the Chief Medical Officer, you will continue growing the Clinical Operations department and will be responsible for the development and oversight of global clinical trials. With excellent financial standing and industry-leading protocols targeting rare & muscular diseases, this company is bringing on the best and brightest in the market.
- Oversight of clinical operations across all sites and clinical centers, including site selection and management.
- Lead patient recruitment and enrollment activities
- Implement clinical outsourcing strategy and process to select, contract and manage CRO and participating clinical centers
- Develop and implement RFPs, SOPs, internal policies, and quality standards in compliance with all applicable global regulations and ICH/GCP guidelines to ensure quality and timely results
- Ensure that all site and vendor activities are compliant with all applicable global and domestic regulations
- Communicate with health authorities, corporate executives, clinical investigators, scientists, investors, and other external stakeholders
- Maintain clinical trial budget and ensure cost-efficiency and timely delivery
- Proactively monitor, communicate, and resolve any issues
- Bachelor’s Degree in life sciences required
- Advanced degree (Masters, PharmD, or PhD) preferred
- 10+ years Clinical Operations experience within the biopharma or biotechnology industries
- Proven Muscular Disease Drug Development success
- Excellent scientific writing
- Strong leadership and communication skills
- Strategic thinker with the ability to thrive in a collaborative, fast paced environment
- Experience growing, training, and developing Clinical Operations teams
If you are a thought leader looking for an exciting opportunity with room for growth, this is the role for you.
My team and I are working on a number of additional opportunities for a broad portfolio of clients across the US and internationally. If this role isn't for you but you would like to explore your options in the market, I would welcome a confidential conversation at your convenience. Please contact me at (619) 350-6149 or firstname.lastname@example.org.