SVP Clinical Operations
Boston, MA (Hybrid)
$260,000 - $310,000
Job Description
EPM is partnered with a client that is pioneering the Rare Disease space by unraveling the complexities of rare and ultra rare diseases with groundbreaking research and innovative technologies. With a product that has already received FDA approval, the mix of financial stability and room for vertical mobility is unmatched. Their commitment extends beyond science, embracing patient advocacy, and fostering collaboration to redefine the landscape of rare disease treatments. They are creating a future where every patients journey is met with tailored solutions for their specific condition. Join this business critical role as a leader and provide strategy and oversight on how to get these treatments to the patients that need them.
Key Qualifications
- Extensive background in rare disease clinical operations, showcasing a proven ability to design and execute efficient and ethical clinical trials within the unique challenges of the rare disease landscape.
- Regulatory Compliance Mastery: In-depth understanding of regulatory frameworks specific to rare disease clinical trials, ensuring seamless navigation through approvals and adherence to stringent regulatory standards.
- Cross-Functional Leadership: Demonstrated success in leading cross-functional teams within rare disease clinical operations, fostering collaboration among diverse experts to drive successful trial outcomes.
- Patient-Centric Approach: A deep commitment to patient-centricity in clinical operations, ensuring that trials are designed and executed with a focus on improving patient experiences and outcomes.
- Strategic Problem Solver: Proven ability to navigate the complexities of rare disease research, developing and implementing strategic solutions to overcome operational challenges and ensure the successful execution of clinical trials.
- Therapeutic Area Knowledge: In-depth knowledge of specific rare diseases and their nuances, enabling the development of tailored operational strategies that address the unique aspects of each disease's clinical trial requirements.
Roles and Responsibilities
- Clinical Trial Design and Execution: Lead the planning and execution of rare disease clinical trials, from protocol development to site selection, ensuring trials are conducted efficiently and ethically.
- Regulatory Compliance: Ensure adherence to regulatory standards and guidelines specific to rare disease clinical operations, collaborating with regulatory affairs to facilitate successful approvals.
- Foster collaboration among various teams, including clinical development, regulatory affairs, and patient advocacy, to integrate diverse expertise and optimize rare disease clinical operations.
- Champion a patient-centric approach in clinical operations, ensuring that trial designs prioritize patient experiences, access, and compliance with the unique needs of individuals with rare diseases.
- Identify potential risks in rare disease clinical trials and develop proactive mitigation strategies, ensuring the smooth progression of trials and minimizing disruptions.
- Oversee relationships with external vendors and partners involved in rare disease clinical operations, ensuring effective communication, budget adherence, and high-quality deliverables.
- Drive continuous improvement initiatives in rare disease clinical operations, incorporating feedback, lessons learned, and emerging best practices to enhance the efficiency and effectiveness of future trials.
Benefits
- 401(k) with percentage match
- Medical, Dental, Vision
- Performance and target based bonuses
- PTO and Holidays
