Prior experience implementing precision medicine approaches in clinical trials including companion diagnostic (CDx) development experience in liquid-based and tumor tissue-based approaches.

The role represents the CPQP function on drug development teams, leads CPQP sub-teams, and owns strategy and delivery on posology for early and late-stage clinical trials while collaborating with clinicians, clinical operations, bioanalytical, biomarker, pharmacovigilance, regulatory and CMC groups.

Reporting to the Head of Clinical Supply Chain, the Associate Director of Clinical Supply Planning will focus on managing and optimizing global supplies to ensure timely availability of clinical supplies for clinical trials.

Hands-on experience with interpretation of flow cytometry data in clinical trials is required. Experience with analysis of clinical biomarker data on gene expression, multi-plex histology and soluble biomarkers is preferred.

What this position is all about : Cellarity is seeking an experienced, talented and highly motivated Director/Sr. Director, Program Management to play a vital role in the company’s efforts to progress small molecule lead candidates through IND and into clinical trials.

Solid understanding of bioanalytical and biomarker strategies, applicable regulatory guidance, clinical trials, endpoints and deliverables. Join us as a BST and Clinical Biomarker Lead, Neuroscience, Associate Director in our Cambridge, MA location.

PRINCIPAL DUTIES AND RESPONSIBILITIES: Study Start-Up·Oversight of the clinical trials start-up process from receipt of proposal materials, protocol development, IRB submissions, through site(s) activation.

Overview The CTO PI-Initiated Research Project Manager (CTO RPM) for Waldenstrom’s Macoglobulinemia Think Tank Network (WM-NET) is responsible for assigned day-to-day coordination and overall management of WM-NET activities for assigned clinical trials and program; primarily multi-center, PI-initiated trials.

PepGen is looking for a highly motivated Associate Director or Director level Biomarker scientist who will contribute to the preclinical/clinical development to support and expand their current and future pipeline.

Deep knowledge of immuno-oncology biology, biomarker strategies and application to clinical trials. Experience in conducting clinical trials and working as part of a clinical study team and other matrix teams.

Conduct final batch disposition of all GMP materials for release into clinical trials encompassing batch record review, change control and investigations. You will use your experience in building and maintaining trusting relationships with key strategic internal and external partners, including the ability to help grow the Quality function to support development programs from preclinical through clinical phases.

You should demonstrate leadership competencies and have extensive experience in SAS programming within biopharmaceutical clinical trials environment and in-depth understanding of CDISC standards and drug development principles, preferably in solid tumor therapeutic area.

Completion of four (4) units of Clinical Pastoral Education. Completion of two (2) units of Clinical Pastoral Education. Communicates relevant patient information with other disciplines through the use of referral systems, chart entries and other mechanisms in the clinical setting.

The laboratory of Dr. Pradeep Natarajan at the Massachusetts General Hospital Cardiovascular Research Center (CVRC) and Center for Genomic Medicine (CGM) and Broad Institute of Harvard & MIT has a unique post-doctoral fellow position open for a highly qualified applicant interested in investigating the genetics and biology of cardiovascular diseases using human genetics across diverse epidemiological cohorts, hospital-based biobanks, and within clinical trials.

The Director, R&D Quality, GCP consults as necessary with quality and study teams on advanced GCP quality assurance oversight and management activities to ensure the highest level of compliance in Vertex CGT clinical trials are in accordance with Good Clinical Practice (GCP) guidelines, applicable regulations, clinical protocols and Vertex policies, procedures, and quality standards as set forth in the Quality Management System.