Director Clinical Operations US
Breath Therapeutics GmbH, Home-Based, US Eastern
Opportunity

As the successful candidate, you will be joining a clinical stage biopharmaceutical company specializing in advanced inhalation therapies for severe respiratory diseases with high unmet medical need. You will play a key role in the execution of an international late-stage program. As such, you will be the face of the company at all European study sites and coordinate all key players on-site. Your job is essential to ensure assigned studies are delivered in line with all set timelines and budgets, but also to establish the company as a recognized player in lung transplant medicine. We are a startup company with a virtual team working in Europe and the US. Currently, we are preparing one of the most interesting inhaled products at the intersection of pulmonary, orphan and transplant medicine for phase 3 studies. For this purpose, we are building a world-class team with a focus on innovation, teamwork and the desire and ability to change the way our patients live. Our company will place great value on the unique skills, talents and qualities that each of our employees brings to us. You can expect an exciting and varied role that will offer a whole host of new challenges alongside fantastic career development opportunities. As such, we are seeking a very pro-active, highly motivated individual with proven management expertise in the area of respiratory orphan and clinical late-stage development alongside with excellent communication and analytical skills.

Responsibilities

You are the central point of contact for the management towards our study sites. As such, you are the on-site manager of all clinical trial activities in the US. In close collaboration with your EU counterpart you will assure the successful execution of our pivotal trials according to timelines and budget. Your role is also key to establish sustainable business relationships with regard to an optimal preparation of the product commercialization phase. Among others, this job encloses the following tasks:

  • Support of the selection process of eligible study centers in the study preparation phase in coordination with the CRO, including planning and execution of investigator meetings
  • Enhancement of recruitment during the execution phase by active management of PI and other key study persons, close interaction, oversight and support of CROs in terms of review and commenting of status and monitoring reports, project-specific administration and further by archiving, documentation of all interaction in CR Database
  • Planning and execution of training of study sites for protocol compliance, correct use of drug and device. This includes device and data management testing, preparation of training material for CROs, physicians, patients along with organization of device data management on-site and with central read-out
  • Oversight and coordination of local processes on-site including management of all third-party providers, e.g. clinical and ancillary supplies management
  • Reporting and co-operation in quality management plans in compliance with GCP and all other relevant regulatory guidelines

Based on your position, experience and communication skills, you are presenting the company and its clinical program on-site and in the community of transplant medicine - this includes:

  • Management of KOL and other stakeholders along with relationship management with international study partners
  • Assure excellent coordination between European and US centers by appropriate measures, e.g. preparation and regular publishing of study newsletter, centralized training sessions on device use etc.
  • Organization of international and local events for study partners and presentation of the company at scientific congresses
  • Align management with patient organizations and medical societies (e.g. ISHLT)
  • Provide ideas and concepts to build up patient registry data (e.g. centralized FEV1 data)
  • Close interaction with Chief Medical Officer and Chief Scientific Officer in terms of medical affairs, e.g. initiation and coordination of publications
Qualification
  • Required Bachelor’s Degree with Masters in life sciences, healthcare or related field
  • Minimum 10 years of experience within the pharmaceutical/biotechnology industry in scientific product management and managing clinical late-stage programs along with experience in medical affairs and KOL management, preferably in respiratory and/or orphan indications
  • Profound knowledge of regulations to conduct international clinical late-stage studies in drug development, familiar with GCP regulations in theory and practice
  • Ideally knowledge of medical devices for inhaled drug delivery and/or lung function testing and/or hands-on experience in patient training
  • Demonstrated strong communication and leadership skills and the ability to work successfully in a matrix team environment in a global setting
  • Strong pro-active and creative worker with excellent written skills, as well as conflict management, time management and organizational skills
  • Competent handling of MS-Office applications (in particular MS Excel, MS Word, MS Project, PowerPoint
  • Fluent English (oral and written), with knowledge of other European languages a plus
  • Ability and willingness to travel, estimated at 50 % with overnight stays including trips to investigational sites and conferences in Europe and USA
About Breath Therapeutics

Breath Therapeutics is a clinical stage biopharmaceutical company specializing in advanced and first-in-class inhalation therapies for severe respiratory diseases with high unmet medical need. For our clinical development, we are using new proprietary drug formulations optimized for inhaled administration with exclusively licensed, high performance nebulizers. Our patient-centered drug development approach is focusing on integrated therapy solutions in the interaction between diagnostic, therapy and eHealth therapy monitoring.

Breath Therapeutics´ lead development program BOSTON is addressing the treatment of Bronchiolitis Obliterans in patients after lung transplantation. With proceeds from a USD 46 million Series A financing by top-tier European investors Sofinnova Partners, Gimv and Gilde Healthcare, we are currently initiating Phase 3 studies in the US and Europe. PARI Pharma, a worldwide leading nebulizer company, is our strategic development partner and licensor for the eFlow® nebulizer technology for the BOSTON program.

Breath Therapeutics is Germany and US based with offices in Frankfurt, Munich and Boston. 

Additional Information

Breath Therapeutics is an Equal Opportunity Employer and will judge all applicants based on their qualifications for the job, without regard to race, color, sex, religion, national origin, age, disability or any other characteristics protected by applicable federal, state or local law.

Unsolicited resumes from agencies should not be forwarded to Breath Therapeutics. Breath Therapeutics will not be responsible for any fees arising from the use of resumes through this source. Breath Therapeutics will only pay a fee to agencies if a formal agreement between Breath Therapeutics and the agency has been established. The Management of Breath Therapeutics is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.

Please note that we review every submission and we will keep all submissions on file for six months. 

Contact:

Breath Therapeutics Inc

90 Canal Street, 4th Floor
Boston
Massachusetts 02114
United States of America

Dr. Renu Gupta, Consulting Chief Medical Officer

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