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 be responsible for ensuring assigned studies are delivered in line with all set timelines and budgets and run in accordance with all internal SOPs and external regulations. You will play a key role in the implementation and management of study plans and key documents and collaborate with all key internal departments including Clinical Trial Supply and Site Management. 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 an open minded individual with proven expertise in study management as well as excellent communication and analytical skills.
- You will serve as leading coordinator for the management and execution of all clinical trial activities in Europe and North America in compliance with GCP and all other relevant regulatory guidelines. Your responsibilities include, among others:
- Effectively manages the cross-functional study team to achieve deliverables with high quality, on time and within budget through information-sharing, ongoing study team meetings/discussions and ensuring effective risk management planning
- Oversees and coordinates all aspects of drug safety
- Monitors study metrics to ensure quality and performance standards are met by vendors and assigned project staff
- Develops and manages detailed project plans and provides regular study and budget status updates to senior management
- Manages vendors’ adherence to contractual obligations including proactively recognizing changes in scope and collaborating with senior management to ensure timely completion of change orders
- Provides coaching/mentoring to assigned project staff (CRAs, and CTAs) by demonstrating leadership competencies
- Proactively identifies potential resource needs to management
- Establishes and maintains relationship with EU Investigators and site staff along with PI and study personal training with respect to protocol compliance
- Participates in the development and review of department SOPs and process improvement initiatives
- Maintains data bases together with the person in charge of the protection of data privacy
- Required Bachelor’s Degree (Masters preferred) in life sciences, healthcare or related field
- A minimum of 10 years of clinical trial management experience within the pharmaceutical/biotechnology industry, managing the logistics of clinical trial execution
- Experience in managing large and/or complex studies and project teams is preferred. Experience in respiratory and/or orphan indications also preferred
- Demonstrated experience managing CROs and other specialty vendors is essential
- Thorough understanding of the drug development process and clinical trial execution, including ICH/GCP requirements and local regulations
- Demonstrated strong leadership skills and the ability to work successfully in a matrix team environment in a global setting
- Excellent written and oral communication 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 in English (oral and written), with knowledge of other European languages a plus
- Ability and willingness to travel, estimated at 25 % with overnight stays including trips to investigational sites in Europe and USA
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.
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.
Breath Therapeutics GmbH
Dr. Gerhard Boerner, Chief Scientific Officer