This role will support the Area Clinical Director in oversight of the location which may include communication of updated policies and procedures case load assignment, additional clinical needs, but not limited to: Responsibilities of the Clinical Director: Maintain open lines of communication with ...
This role will support the Area Clinical Director in oversight of the location which may include communication of updated policies and procedures case load assignment, additional clinical needs, but not limited to: Responsibilities of the Clinical Director: Maintain open lines of communication with...
Work with cross-functional clinical team, including clinical operations, clinical pharmacology, pharmacovigilace, statisticians, data management, and members of multidisciplinary project teams to guide data collection and data interpretation. The Clinical Scientist is responsible for Sobi&rsqu...
Investigator Brochures, and clinical study reports; review SAPs and TLF shells; participate in emerging clinical trial data evaluation and interpretation; ensure that assigned studies are conducted according to GCPs and Fusion’s SOPs; conduct literature searches and reviews, meta-analyses, and publi...
This role will report to one of Modernas Senior Directors, Clinical Development, Infectious Diseases and will be the primary point person for the medical oversight of clinical studies with responsibilities to include clinical trial design, protocol development, Sponsor medical monitoring, review and...
The person in this role has a strong knowledge of best practices in Clinical Pharmacology and Pharmacometrics, hands-on experience in designing and executing clinical pharmacology studies and PK/PD modeling plans, and the ability to make data-driven decisions and contributions towards clinical devel...
Associate Clinical Data Management Director. Our clinical research and development team is dedicated to tailoring cell and gene therapies to individual patients, specifically working on treatments for hematological cancers using chimeric antigen receptor (CAR) T cell technology. Provide input to stu...
The committee consists of 35-40 global leaders in MS clinical and translational research and is well known for the development of McDonald Diagnostic Criteria for MS, the MS clinical course descriptors, clinical trial design methodologies, and guidance regarding the treatment of MS. The mission of t...
We are building a novel non-clinical statistics function within our Data Science and Modeling and Simulation team in PK Sciences which is part of our Translational Medicine Organization. Build and lead an industry leading non-clinical statistics function to support our different disease areas and fu...
As a Clinical Data Standards Associate Director working on the Clinical Data Strategy & Management team, you will be empowered to collaborate with cross-functional teams and oversee Vertex’s standards for data collection and cleaning and associated processes. Clinical Data Strategy & Mgmt As...
BST Lead will support the clinical development of novel therapeutics by developing translational and clinical biomarker strategies for preclinical and clinical programs through cross functional collaboration with NS Clinical Sciences, NS DDU, Clinical Pharmacology, DMPK and others as well as externa...
Reporting to the Senior Director, Clinical Data Management, the Associate Director, Clinical Data Management will define and lead the clinical data management strategy for the organization. ASSOCIATE DIRECTOR CLINICAL DATA MANAGEMENT (This role is based in Company's Waltham, MA headquarters. The Ass...
The successful candidate will support multiple early-stage assets for heart failure and other cardiovascular indications, and be responsible for defining the late stage clinical development plan for each asset, working closely with therapeutic area Clinical Development & Operations to meet clinical ...
The ideal candidate will have a strong knowledge of best practices in Clinical Pharmacology and Pharmacometrics, extensive experience in designing and executing clinical pharmacology studies, and a demonstrated ability to make data-driven decisions based on preclinical and clinical information. The ...
Reporting to the Senior Director of Clinical Development, the Associate Director/Director will provide clinical and scientific input to early-stage clinical development programs. The Associate Director/Director will have a significant role in clinical study oversight and deliverables, including revi...
The Director of Clinical Development will progress the clinical development of Invetx’s portfolio of development projects from nomination as development candidates through to global regulatory approval. The Director of Clinical Development will play a key role in the progression of Invetx’s developm...
Perform quality review checks on key clinical documents such as clinical protocols, informed consent forms, case report forms, clinical monitoring plan, monitoring reports, etc. The sponsor oversight monitoring role plays a significant contribution to the clinical quality risk management strategy fo...
This role will support the Area Clinical Director in oversight of the location which may include communication of updated policies and procedures case load assignment, additional clinical needs, but not limited to: . Responsibilities of the Clinical Director:. The Nursing Director provides overall m...
The purpose of the Senior Director of Clinical Research role is to coordinate and lead the development of first in man (FIH), proof of mechanism (POM), proof of clinical activity (SoCA) and proof of concept (PoC) and dose ranging studies for novel biological and small molecule therapies in. Provide ...
Oversee investigator-initiated and grant funded clinical trials including development of protocols/budgets, support the contract process, and coordinate correlative sample processing Lead process improvement projects to increase accrual and study approval/activation timelines Lead process improvemen...
Reporting to the Senior Director, Clinical Data Management, the Associate Director, Clinical Data Management will define and lead the clinical data management strategy for the organization. ASSOCIATE DIRECTOR CLINICAL DATA MANAGEMENT. The Associate Director, Clinical Data Management is responsible f...
The Director, Clinical Operations is a leadership role responsible for overseeing and managing all aspects of clinical operations for a high priority immunology program. This individual possesses clinical operations expertise with a track record of success, working with peers and stakeholders across...
You will represent clinical science on study management teams, training internal and external staff, monitoring clinical data, and responding to health authority requests related to the assigned clinical development activities. Gives clinical and scientific input to and reviews clinical regulatory d...
Reporting to the Senior Director, Clinical Data Management, the Associate Director, Clinical Data Management will define and lead the clinical data management strategy for the organization. ASSOCIATE DIRECTOR CLINICAL DATA MANAGEMENT (This role is based in Company's Waltham, MA headquarters. The Ass...
Dyne has a broad pipeline for serious muscle diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and a preclinical program for facioscapulohumeral muscular dystrophy (FSHD). The Associate Director, Clinical Data Analyst, has a critical rol...