What are the responsibilities and job description for the Manager/Senior Manager, Translational Operations position at Cardurion Pharmaceuticals, Inc?
Job Description
Job Description
Description :
Why join Cardurion Pharma?
We are a clinical-stage biotechnology company discovering and developing new therapeutic approaches to treat cardiovascular disease. We have built a pipeline of novel therapeutic product candidates that have the potential to address the significant morbidity and mortality that remains for patients suffering from cardiovascular disease. We invite you to explore our website to learn more about our Company and how we are advancing towards our goal of building a world-class biotechnology company that discovers, develops and commercializes life-changing therapeutics for patients with cardiovascular disease.
The Role :
We are seeking a highly motivated, experienced clinical translational operations professional to join our team headquartered in Burlington, MA. Reporting to the Head of Translational Medicine, the desired candidate will work with stakeholders on internal program teams and cross-functionally with colleagues in Translational Medicine, Clinical Operations, Clinical Development, Data Management, Regulatory, and Quality to execute the strategy, operations, and logistics with multiple external vendors related to each of clinical pharmacokinetics (PK), clinical pharmacodynamics (PD), and clinical biomarkers on multiple clinical trials across the portfolio programs.
Here’s What You’ll Do :
- This position requires a combination of scientific and project management expertise as they will be responsible for the support of clinical laboratory functions within clinical trials, including being accountable for secondary clinical laboratories that are not part of a study’s Central Safety Laboratory.
- Coordinates with each clinical study team to deliver the appropriate collection, processing, stability, shipping, and testing strategies in accordance with the requirements of quality, as well as ethical and regulatory standards, including ICH, GDPR, GCP, and GLP.
- Reviews and provides input into clinical study protocols, informed consent forms, and central laboratory documents (e.g., laboratory manuals, data transfer agreements) to ensure accurate and precise operationalization of PK, PD, and biomarker strategies.
- Assists with the operational oversight of PK, PD, and biomarker laboratories, including vendor selection and management, set-up activities (e.g., laboratory manual, kit configurations, data transfer plan, database set-up, coding), sample testing schedules, and data delivery to the CRO.
- Functions as the point of contact for multiple PK, PD, and biomarker testing vendors , managing risk in collaboration with Quality, including issue identification, resolution, and corrective action implementation.
- Processes MSAs, SOWs and other agreements with specialty labs; manages P.O.s and tracks invoices
- Tracks samples end-to-end throughout the sample lifecycle, from collection to final disposition
- In partnership with Quality and Data Management, assists with the quality and data accuracy delivered by the central and specialty labs
- Works effectively in a dynamic operational environment with cross-functional stakeholders.
Here’s What We’ll Bring to the Table :
Our Mission :
Translate our world-class expertise in cardiovascular signaling pathways into potentially groundbreaking therapeutics for patients.
Cardurion is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Cardurion will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Requirements :
Here’s What You’ll Bring to the Table :
