VP or Sr. Director of Clinical Operations - Medical Device
Package: $150,000 - $250,000 base + bonus + equity
Location: Minneapolis, MN
Context:
We are partnered with fast moving, highly innovative start-up aiming to bring a life-saving medical device to market. We are looking for an experienced leader to oversee all aspects of clinical operations, including strategic development, patient recruitment, data management, regulatory compliance, staff supervision, and vendor management (inc CROs).
A few benefits of this role include;
A seat on the board of directors.
Working to bring life-saving technology to market.
Equity in a well-funded start-up at the perfect time for growth and poised for success in a huge market.
Joining a start-up which has a fantastic reputation with physicians.
Transparent, collaborative, reputable team who make quick decisions.
Hands on role in fast-moving start-up environment.
Strategic influence, responsibility and respect.
The list goes on...
*** Please keep in mind that this role is based in Minneapolis and is an ON SITE position. This means a relocation would be required if you do not live in Minneapolis. ***
Responsibiities
The Sr. Clinical Director oversees and manages clinical staff, including Contract Research Organizations (CROs) and consultants. This role involves strategic and tactical implementation of clinical programs, including designing, executing, and analyzing clinical studies, as well as developing and improving internal procedures.
Strategic Development and Clinical Research Oversight
Design and develop pre-market clinical study plans, study protocols, informed consents, case report forms (CRFs), and other study-related materials.
Provide expertise and guidance in interpreting governmental regulations, applicable regulatory guidelines, and internal policies to ensure global compliance with pre-market clinical work.
Develop, maintain, and track detailed project timelines for clinical studies and develop contingency plans.
Serve as a clinical leader, providing feedback and guidance throughout the product development cycle, participating in cross-functional team meetings, and coordinating activities to support clinical study cases and business goals.
Determine costs and resources needed to execute clinical studies and generate budgets for Clinical Operations.
Key Operations Activities
Ultimately responsible for patient recruitment and adherence to clinical study timelines, supporting recruitment strategies to meet study goals.
Ensure timely and efficient data management to maintain scientific integrity and data quality from clinical sites and core laboratories.
Oversee site management and monitoring activities to ensure data quality and site compliance.
Review, write, and approve (or guide others in writing) various reports, including annual, final, safety, DSMB, and clinical sections of regulatory applications.
Oversee DSMB/CEC management.
Assist regulatory teams with timely safety reporting to ensure adherence to GCP, FDA, and other country-specific regulations.
Analyze and evaluate clinical data, presenting information regarding the company's clinical investigations.
Serve as a key clinical representative in risk assessment activities with quality and engineering teams, ensuring that patient and clinician risks are clearly accounted for and realistically assessed.
Provide input and assist in developing materials for training sessions for clinical sites and internal Clinical Field Specialists, assisting with site training and in-services as needed.
Ensure that clinical study registrations on clinicaltrials.gov are maintained according to regulations and reporting requirements.
Supervision of the Staff
Supervise daily activities and workloads of clinical staff, quickly adapting to changing demands and prioritizing work to meet business goals.
Conduct regular performance assessments, including annual reviews.
Oversee departmental training and monitor compliance with SOPs and relevant regulations.
Conduct and participate in meetings with Clinical Operations personnel to establish and review organizational policies, coordinate functions and operations between departments, and establish responsibilities and procedures for attaining objectives.
Identify potential hiring needs and recruit candidates with HR assistance.
Establish, track, and report on performance metrics to present clinical trial progress and performance.
Manage relationships and contracts with CROs, independent contractors, and vendors to ensure efficient operations.
REQUIREMENTS
5 to 10 years of medical science/clinical experience, including designing, executing, analyzing, and presenting clinical trial results.
At least 2 years of CEC/DSMB management experience, including narrative preparation, meeting execution, and results processing, monitoring, and data management.
At least 5 years of direct management experience with the ability to mentor and develop teams.
Proven leadership with IDE studies conducted in the US, EU, and Asia.
Proven hands-on experience in start-up environment. *
If this sounds like you, please send your resume to elliot@plexus-partners.com