(Senior) Manager, Clinical Scientist (Personalized Cancer Vaccines)

Open for hire at one of the following locations –  Cambridge Erie Street. - Job ID: 6954 

 

Join our team of pioneers!

As a part of our team of more than 5.000 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age. Within less than a year, we were able to develop our COVID-19 mRNA vaccine following the highest scientific and ethical standards – writing medical history.
 
We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives.

 

(Senior) Manager, Clinical Scientist (Personalized Cancer Vaccines) 

 

Responsibilities:

• Contribute to the development and creation of clinical trial protocols following high scientific and clinical standards and applicable regulations.
• Contribute to identifying, formulating, and implementing amendments to clinical protocols in close collaboration with the clinical lead.
• Contribute to study-level documents, including preparing clinical sections of key regulatory documents such as Investigator Brochures, briefing books, safety updates, and submission dossiers.
• Review and write clinical trial documents for CTR activities and publications (if applicable).
• Support pharmacovigilance activities (e.g., contributing to aggregate reports, patient narratives, attendance of pharmacovigilance monitoring meetings).
• Support regulatory activities, like preparation of meetings with regulatory agencies.
• Produce training materials, share best practices, and provide training to the broader clinical trial teams.
• Participate in study-level meetings, such as Investigator Meetings, Data Monitoring meetings, etc.
• Guide the development of data review strategy, ensuring that protocol-level deviations, eligibility criteria, study assessments, and other aspects of the protocol are implemented consistently across the study.
• Perform high-quality clinical data review and identify clinical data insights through ongoing patient-level review and trends analysis.
• Work to improve the quality of reviews/insights, emphasizing subject safety and eligibility, data integrity, trend identification, analysis and remediation, and identification of cases for medical review.
• Provide insights to and facilitate data review process improvements, for example, by identifying redundant reports, implementing innovative data analysis processes and tools, and their continuous improvement.
• Work in close collaboration and alignment with the clinical development lead. Ensure all questions/issues requiring medical oversight are brought to the attention of the clinical development lead.
• Keeping up-to-date with the latest scientific and clinical developments in the field of interest, and contributing to the development of scientific publications, presentations, and other materials.

 

Qualifications:

• Advanced life sciences/healthcare degree (or clinically relevant) is required.
• Master’s, PharmD, MPharm, PhD, MBBS, BDS, MD strongly preferred.
• Strong familiarization with Good Clinical Practice (GCP) and drug development processes, ideally Phase 1 – 3; ideally paired with experience in Oncology/Immuno-Oncology.
• Good knowledge of set-up, organization, and execution of global clinical studies in a pharmaceutical company, cont