Director Clinical Affairs

Job content

Clinical Affairs Director (m/w/d), CorFlow Therapeutics AG, Switzerland

About CorFlow Therapeutics AG

CorFlow Therapeutics is a med-tech start-up founded in 2016 by renowned interventional cardiologists and medical device entrepreneurs. The company office is located in Baar (Zug) and Bern. Corflow is developing proprietary technologies for diagnosis and treatment of microvascular obstruction, after myocardial infarction. The company has developed the 1st generation CorFlow console and catheter and is running the First-in-Human multi-center European clinical trial, MOCA I trial. A 2nd generation device is currently under development together with external partners. CorFlow is seeking an experienced Clinical Affairs Director to lead and support the clinical activities, for current and future trials.

As Clinical Affairs Director, you will be part of CorFlow Management Team and your key responsibilities will include:

Lead the development of clinical evidence strategies to best position the company for successful regulatory approvals, marketing claims and commercialization.

Design and lead the execution of clinical studies for regulatory submissions, reimbursement, and market adoption, including protocol, site recruitment, internal compliance approvals, budget and agreement negotiation, study initiation, trial maintenance, data monitoring, data reporting, vendor selection and management, trial master file maintenance, and product and payment tracking.

Create the publication strategy, lead abstract and manuscript writing and submission activities.

Contribute to writing and review of clinical documents in regulatory agency submissions.

Oversee and/or contribute to the preparation of clinical documents, e.g. protocols, investigator brochure, case report forms and clinical study reports, monitoring plans and budgets.

Serve as clinical team expert to provide direction to all project team functions as well as identify and liaise with IRB, CEC, DSMB and KOLs regarding program strategy and scientific advice.

Interpret study data and develop integrated summaries for safety and efficacy.

Utilize communications, reports, EDC, and CTMS systems to proactively identify potential barriers to project completion and data integrity and proactively implement effective strategies to correct/avoid such barriers.

Manage External Research proposals- overseeing corporate approval processes, execution of agreements, completion of milestones and reports, and payments or in-kind contributions.

Contribute to review and approval of risk management plans, design reviews, and IFUs, where clinical input is needed.

Qualifications needed:

Minimum of 10 years’ experience in Medical Affairs and Clinical Operations in medical devices, including monitoring activities and full site management

Tracked records of implemented clinical strategies development to achieve market approval and reimbursement for medical devices in EU and US

Solid European and US interventional cardiology KOL relationships is a plus

Proven ability to interact with competent authorities, ethics committees and investigators

Ability to manage CRO’s, core labs and external vendors

Understanding of device – drug combination products and experience in the field of interventional cardiology is a big plus

Flexibility and ability to interact in a small sized start-up environment

Fluent English language skills orally and in writing, fluency in additional European languages are valued

Proven ability to hire and manage a team to a high performance standard.

We offer a full-time contract with a competitive salary in a pioneering start-up environment with work location in our headquarters in Baar, our laboratory and offices in Bern or from a primary home office location in Europe or US.

If you possess the required experience and qualifications and want the challenge of growing with our company, please submit your application including latest CV and cover letter to Sara Specchia sspecchia@corflow.ch | HR Manager | +41 76 216 27 53

Corflow is an equal employment opportunity employer. Employment and advancement opportunities are available to all individuals regardless of their race, color, national origin, religion, ancestry, citizenship status, sex, sexual orientation, gender identity or expression, age, marital status, family responsibilities, pregnancy, disability, or any other protected characteristic.