We are looking for a Director Clinical Operations at EpiEndo Pharmaceuticals, is that you?
EpiEndo is a clinical stage pharmaceutical company with a unique focus on impairment of epithelial barriers as a common mechanism of many inflammatory conditions such as the airway, GI tract and skin. Our lead program EP395 is currently in Phase 1 but will expand into Phase 2 in 2022. We are therefore seeking a Director Clinical Operations to join us on this exciting journey.
EpiEndo is in part a virtual company, with offices in Iceland, but with the majority of people working remotely from home across Europe. However, we try to meet regularly face to face and we have a great team working closely together despite long distance!
As the Clinical Operations Director you will:
· Provide overall clinical operational leadership and oversight, including management of EpiEndo Clinical Project Managers
· Develop appropriate budgets and manage the budget in order to ensure the clinical studies and development plan meet the agreed timelines and quality standards
· Monitor study progress and ensure proper resource planning and allocation for successful project deliverables against company goals and timelines
· Be accountable for the development and writing of study protocols, protocol amendments, Informed Consent, Case Report Forms (CRF), study summaries, Clinical Study Reports (CSR) and any other key documents related to the execution of the clinical studies
· Lead and support data management activities for clinical studies, e.g. maintain oversight of organization/structure of clinical and safety databases, monitor data management compliance activities including data quality and integrity, data formatting (e.g. CDISC) as required per ICH and regulatory guidelines.
· Lead site selection/site qualification discussions with Clinical Project Managers, and Clinical Research Organization (CRO)
· Lead CRO and clinical vendor selection and management
· Provide detailed CRO and vendor oversight of any trial-related duties and functions
· Contribute towards development and implementation of quality processes and procedures to ensure clinical studies are managed within a robust regulatory and operational framework to ensure data validity and quality
· Maintain oversight and co-ordination of internal and external vendors including Safety/Pharmacovigilance, Data Management, Regulatory submissions, Quality Assurance, Medical etc for preparation, execution and reporting of clinical studies
· Support the development of clinical development plan(s), target product profiles (TPPs) and support the ongoing assessment of the clinical strategy and timelines
· You will be part of the Clinical Development Management Team and of the extended EpiEndo Leadership Team.
Qualification, Education and Experience Requirements highlights
· A Bachelor’s degree or equivalent in Life Sciences as a minimum
· Preferably specific relevant training and education in project management and clinical development or equivalent
· Minimum of 5-10 years senior responsibility in clinical development operations roles across all phases of drug development
· Building, developing and leading clinical operation teams and study teams
· Preferably experience in working in small start-up life science companies
· Managing global clinical development programs and studies and demonstrable professional knowledge of regulatory requirements, managing CROs and compliance practices
· Previous experience of clinical trials in the respiratory therapy area is desirable but not essential
Preferred Skills and Competencies
· Ability and willingness to operate at both leadership level and operational execution level
· Excellent oral and written communication skills in English
· Self-motivated and able to work independently and have strong organizational skills
· Detail oriented with high standards for quality
· Ability and drive to deliver on goals, objectives and timelines
· Proficiency in computer applications such as Word, PowerPoint, Excel, Outlook, etc.
EpiEndo is a clinical-stage biopharmaceutical company with a unique approach to inflammatory disorders that focuses on enhancement of epithelial barrier integrity as a causal pathophysiological factor underlying the etiology of several major diseases. Epithelial cells are a key component of the barrier that makes up human skin and lung tissue, as well as the intestinal tract and genitalia. Compromised integrity of this barrier is implicated in the progression and non-resolution of inflammation.
EpiEndo is developing a proprietary portfolio of orally available drug candidates with promise as first-in-class disease-modifying therapeutics, to address the huge global burden of chronic respiratory diseases and other significant unmet medical needs.
EpiEndo’s lead drug candidate, EP395, aims to be the first on-market oral, disease modifying, barrier strengthening and anti-inflammatory drug for COPD.
For more information, please visit www.epiendo.com
Application & Contact
Please send your CV and cover letter to firstname.lastname@example.org.
Should you have any questions, please email HR@epiendo.com or call +354 454 0090 and ask for Maria Bech (CEO) or Ginny Norris (CMO).
Closing day for applications is 22 December, 2021.
No agencies or recruiters please.