Clinical Operations Director

**About Corteria Pharmaceuticals**

Corteria Pharmaceuticals is a privately held company that develops first-in-class drugs in subpopulations of heart failure and obesity. Our strategy involves innovative stratification of patients and selection of our targets based on human validation. We use state-of-the-art methods to stratify patients and identify those who will benefit most from our treatments. Our programs aim to treat worsening heart failure, right heart failure and acute heart failure.

To support the clinical development of our projects, we are looking for a Clinical Operations Director

to manage the clinical operation activities of the company's products according to the defined strategy and in compliance with ICH/GCP/GLP/GMP standards.

**Position Summary:**

The Clinical Operations Director is an expert in clinical trial implementation and drug development. This individual must have a solid understanding of FDA, EMA, HIPAA clinical research regulatory requirements, good clinical practices, project management, ethical standards and data handling that govern both clinical research and patient privacy. S/He must be an instant contributor who is quick-on-their-feet and have the leadership experience to immediately orchestrate multiple internal and external parties to ensure flawless execution of the clinical research trials. S/He must have strong financial acumen and the ability to negotiate and manage clinical trial budgets to ensure expected financial deliverables are attained. S/He must also have strong communication skills and must be able to work in a highly dynamic environment This individual must be able to perform at a high level of autonomy and be able to make strategic decisions through appropriate interactions with direct supervisor.

**Major Duties and Responsibilities:**

**Leadership:**

o Excellent oversight of each external vendors in adherence to ICH E6 (R2) data integrity requirements.

o Escalate issues where appropriate, and make the appropriate changes in order to ensure trial conduct is completed in compliance with company’s business objectives.

o Ensure clinical trial team and clinical trial sites are properly trained and in compliance with company and/or CRO SOPs, CFR/EMA regulations, ICH GCP guidance, and study protocol.

Identify any gaps in company/CRO SOPs and develop internal SOPs as needed

o Establish strong relations with clinical trial sites and external stakeholders to ensure proactive management of risks.

o Collaborate with team to identify and implement best practices for optimizing performance.

**Execution:**

o Identify and contribute to the selection of the most appropriate CROs and external vendors to conduct the clinical trials by assessing contracts and negotiating pricing.

o Evaluate clinical protocols to assess feasibility and optimize study implementation.

o Support the CROs with site recruitment plans based on thorough feasibility assessment

o Support the CRO/s with site set-up activities including field visits, if appropriate.

o Ensure that clinical trials are successfully executed (set up to close out) in a timely manner, within budget, and in compliance with SOPs, regulations and ICH/GCP guidelines.

o Develop and implement performance metrics based on benchmarked KPI (key performance indicators) & KRIs (Key Risk indicators) to track deliverables as per contractual obligations

o Responsible for ensuring the trial is “audit ready” at all times using an audit plan and address any audit observations appropriately and in a timely manner.

o Work with appropriate team members to ensure that all TMF-related documentation is current, on-file at respective site, CRO, and sponsor locations throughout trial conduct.

o Share responsibility with CRO/external vendors for clinical project deliverables such as investigational product brochure, Pharmacy Manuals, informed consent, IRB submissions/approvals, site activations, monitoring plan and tools, CRFs, DMP, edit checks, safety plan, DMC charter, close-out plans, and CSRs.

o Assist with the development of presentations, handouts, and coordination of Investigator Meetings.

Communication:

o Open, effective, and proactive communication of the clinical operations activities (compliance metrics, alliance management) and timelines is critical for success in this role.

o Escalate unresolved issues and risk mitigation plans to direct supervisor.

o Communicates regularly with clinical trial sites to ensure proper execution of the study and proactive mitigation of risks.

o Proficient written and oral communication skills in English is key for this position.

**Requirements/ Qualifications:**

**Education:**

o Bachelor’s degree in life sciences is required. Pharmacist, MD or PhD degree in a related field, such as biology is preferred.

**Experience:**

o Minimum of ten (10) years of relevant clinical research and operations experience required, preferably in a biotech setting

o Must have experience selecting the most appropriate CRO to conduct the clinical trials by assessing vendor proposals and negotiating pricing and contracts.

o Experience in cardiovascular/metabolism clinical research is preferred.

**Setting and reporting structure:**

**Work setting:**

o Hybrid with at least 2 days/week at the office in Massy, France

**Supervision:**

o Reports to the Chief Medical Officer