The Renal Division of OPKO Health, Inc. (NASDAQ: OPK) focuses on developing proprietary products to treat secondary hyperparathyroidism (SHPT) associated with chronic kidney disease (CKD). We are proud of our lead nephrology product, Rayaldee® (calcifediol) extended-release capsules, launched in 2016 in the US and recently approved for marketing in many other countries. OPKO’s expertise in vitamin D chemistry, biochemistry, metabolism and physiology, combined with its experience in successfully bringing vitamin D therapeutics to market uniquely positions the Renal Division to improve the lives of CKD patients.
The Renal Division of OPKO Health is seeking a Director of Clinical Operations.
Summary: The Director of Clinical Operations will support the clinical development programs for the lead drug product in company-sponsored and investigator-sponsored trials. The successful candidate will provide leadership and program oversight to plan, conduct and manage multiple high quality clinical trials concurrently in accordance with CFR, EMA, and ICH GCP regulations in support of regulatory authority submissions. The Director reports to the Senior Vice President of Research & Development and the role is based in the Design District in Miami, Florida.
Major Responsibilities and Duties
The Director of Clinical Operations will manage all operational aspects of clinical development projects supporting new and expanded indications for the company’s lead pharmaceutical product. Open, effective and proactive communication of these clinical development activities is critical for success in this role. The successful candidate must have an excellent understanding of the international drug development process in order to effectively manage internal and external cross-functional teams. Further, this candidate must have strong communication and analytical skills, excellent attention to detail, capability to manage multiple projects in a fast-paced environment, and be able to work independently and productively.
Responsibilities will include:
- Conduct of pharmacokinetic, bioequivalence and safety and efficacy clinical trials in phases 1 through 4 of the clinical development process.
- Overseeing, leading, and managing cross-functional teams and external service providers (including clinical operations, medical monitoring, safety, data management, auditors, and consultants) to successfully conduct trials on schedule, on budget, in compliance, and to the highest quality.
- Coordination/execution of all operational aspects of clinical studies (including identification and management of vendors, ensuring availability of test drug supplies at the clinical sites, arranging for timely analysis of biological samples at clinical laboratories, overseeing appropriate analysis of clinical data, and preparation of CSRs).
- Working collaboratively with cross functional internal and external teams including regulatory and scientific affairs, medical writing, data management and biostatistics.
- Identifying, qualifying, auditing and managing external vendors, including CROs, taking initiative to escalate issues to senior management when appropriate, and making appropriate changes in project management/logistics in order to ensure trials are conducted in compliance with all applicable regulations and company business objectives.
- Ensuring clinical trial teams and clinical trial sites are properly trained and operating in compliance with company and/or CRO SOPs, CFR/EMA regulations, ICH GCP guidance, and study protocols.
- Identifying any gaps in company/CRO SOPs and developing/revising internal SOPs, as needed.
- Identifying, qualifying, managing, and maintaining strong and productive relationships with clinical trial sites, including personally collaborating with Principal Investigators and field teams on developing robust study operating protocols and patient recruitment programs that deliver enrollment targets. Performing site monitoring with field teams, as needed.
- Facilitating all start-up activities for clinical studies including but not limited to identifying qualified investigational sites, negotiating site and vendor contracts and budgets, and preparing ethics committee submissions.
- Writing, reviewing, and/or approving clinical project deliverables such as scope definition documents, investigational product labeling/kitting, pharmacy manuals, informed consent forms, IRB submissions/approvals, site activations, monitoring plans and tools, CRFs, DMPs, edit checks, safety plans, DSMB charters, close-out plans, and CSRs.
- Assisting with the development of presentations and handouts related to clinical studies, and coordination of Investigator Meetings.
- Ensuring that trials are “audit ready” at all times.
- Working with appropriate team members to ensure that all TMF-related documentation is current, on-file at respective sites, and CRO and sponsor locations throughout trial conduct.
- Notifying and preparing clinical teams for regulatory agency audits and addressing any audit observations appropriately and in a timely manner.
- Performing oversight of trials to ensure that safety concerns and/or adverse events/SAEs are properly tracked and reported.
- Providing regular updates to OPKO management teams, vendors and contract staff concerning status and progress of trials.
- Proactively monitoring and reporting trial progress and performance, timelines, and financial metrics on an ongoing basis to senior management team, including current status of study milestones and forecast budgetary requirements based on scope of work.
- Masters or doctoral degree in health/biological/clinical sciences or related field of study.
- At least 10 years demonstrated experience in clinical operations/ product development/analysis of clinical research in the biotech and/or pharma areas.
- High initiative, demonstrated effective leadership and strong written and verbal communication skills with good attention to detail.
OPKO Health provides an entrepreneurial culture and small company environment with easy access to senior leadership and opportunities for contribution, visibility and recognition. OPKO has a strong history of financial performance. OPKO Health provides competitive salaries, with excellent health and financial benefits. EOE/M/D/V