Our client is looking for a laboratory supervisor to join their team immediately. They are looking to create a new kind of lab and solve the most urgent challenges of medical care. To help facilitate that they need a proven leader who can help lead the team and allow them to offer a new solution for home sample collection and testing. We’re currently recruiting team members who are: • Biased...

The Director/Senior Director of Program Management will lead and organize program teams for the clinical-stage programs and for other programs in developmental stages. This role will plan and coordinate resources to attain program and corporate objectives and serve as the point of contact for all aspects related to their programs. Working in a program team /matrix structure, the Program Management...

As a Regulatory Affairs Consultant, you will: Be responsible for Regulatory technical writing (clinically focused) to support the development of clinical documents in accordance with ICH/E6/GCP guidelines to support US/EMA submissions, clinical trial applications, and clinical consultation responses.   Qualifications: · RA professional with 5-10 yr experience in clinical development that...

As a Senior/Consultant, Regulatory Labeling, you will: • Collaborate with the client and their partners on an effective and efficient process for the global distribution and tracking of labeling updates for products • Disseminate and track approved labeling documents and supporting documentation for labeling compliance distribution and implementation requirements • Team with Senior...

We are seeking an experienced Regulatory Generalist to join our team as a Senior Regulatory Affairs Associate or Regulatory Affairs Consultant and work closely with one large, dedicated client and Regulatory specialist to provide operational support in the IND/NDA maintenance stage. The Sr. Associate / Consultant will provide appropriate regulatory guidance to Project Teams for the development of...

The incumbent will join a dynamic multi-disciplinary multi-modality drug product development team, with responsibilities that span from formulation development to fill-finish of clinical, commercial, and life-cycle stage assets within the Biologics Drug Product Development and Manufacturing which is part of the Global CMC Development organization. Key Responsibilities: The Senior Scientist role...

The Strategic Project Manager will lead, execute and deliver strategic site projects, accountable for successful delivery, timeline, the scope of work, cost/profitability. He/She will be responsible for planning and implementing the project scope in a timely manner, ensuring the cost and benefits are met. Also, responsible for reporting, monitoring, and visualization of progress to ensure a...

As a key member of the Quality team, the Quality Senior Manager/Associate Director will report to the Head of Quality and Regulatory and be recognized as having expertise in the principles and application of quality assurance and compliance related to product disposition. The Quality Senior Manager/Associate Director is expected to coordinate GxP development and manufacturing activities in support...

The AD, Dir, SR Dir, or VP of Regulatory Affairs is expected to oversee and manage the broad regulatory obligations, expectations, strategic and execution needs of the company. They will work in collaboration with internal and external experts to assure that they are accountable for the planning, preparation, and management of simple and complex regulatory submissions. They will act as a liaison...

Our client is seeking an AD/Director Quality Assurance to manage the development and oversight of their Quality Management System and support the GLP and GMP activities (both internal and external) required for their neoantigen cancer vaccine program. This role is highly visible inside of the organization and will be hands-on with a small team to help support. The ideal candidate has PH I-III...

Precision Life Sciences is seeking an Associate Director, Statistical Programming for our client. The client is focused on restoring healthy primary immune system function by developing novel therapeutics for the treatment of rare diseases. This opportunity will … • Align with your values and grit and passion for innovative science. • Leverage your deep knowledge of statistical programmin...

Our client is seeking a Biospecimen Project Manager with responsibilities to include:   • Accountable for clinical sample logistic planning and coordination with clinical sites, external labs, vendors, and couriers to define sample processing and movement timelines needed for sample testing and transfer. Oversee all operational activities required to ensure high-quality sample processing,...

The Clinical Data Manager oversees clinical trial data and sets priorities to ensure that all data management procedures are executed with accuracy and timeliness. As a subject matter expert, the incumbent will work on multi-functional teams and supports clinical data management. Duties include but are not limited to: Research Development Clinical Data Management Services 1. Represent...

Precision is seeking Clinical Project Managers to join a variety of our client's clinical teams. This is an excellent opportunity for someone with strong organizational skills and the ability to work on a variety of tasks and projects simultaneously with minimal supervision. In addition, the successful candidate must have good judgment, be flexible when different tasks arise and be detailed...

This CRA role offers the opportunity to go beyond the role of a typical clinical monitor. CRA’s are accountable for using their expertise to build and maintain the site relationship and ensure they’re set up for success. As the clinical sites’ sole point of contact, this includes addressing and resolving site issues and questions. You’ll also manage site quality and delivery from site identificati...

The Clinical Trial Manager OR Clinical Operations Lead (COL) serves as the clinical functional lead, accountable for the clinical monitoring/site management delivery of assigned study(ies). The position as defined by scope provides leadership, mentoring, and technical support to the Clinical Operations team to ensure the quality of deliverables and achievement of financial goals. May provide...

Early Phase Development Program Manager Seeking a motivated Development Program Manager to join as a key member of an R&D team. The candidate, together with the Program Leader, will be responsible for planning and managing the execution of oncology drug discovery programs from target discovery through to First in Human/Proof of Concept studies. The PM will be responsible for building high...

We are working with a client that is seeking a Medical Director/Senior Medical Director that will report to the Head of Clinical Development.  The Medical Director will be responsible for assisting with the advancement of specific radiopharmaceutical oncology programs by devising clinical development strategies and by serving as a representative for Clinical to project-specific Development Teams....

Precision Life Sciences is seeking a talented Principal Data Scientist to provide scientific expertise and leadership in using advanced computational methods enabling immunology research, optimization of our client's proprietary platform and supporting immune-oncology clinical trials. The successful candidate will possess the ability to work within a fast-paced multidisciplinary environment to...

Scope of Work and Responsibilities: Management of GxP Document Control and Archival: • Manage the GxP Document and Records Management Program (hybrid mode; paper and electronic) • Author Quality System SOPs and policies in alignment with applicable regulations • Subject Matter Expert in the use of electronic document management system (Veeva Vault QualityDocs), workflow lifecycles,...

Precision is seeking a Quality Assurance Specialist to provide Quality oversight for Manufacturing and Quality Operations, including documentation review of executed Quality records. This candidate will also assist in the development, implementation, and maintenance of quality systems and other Quality Assurance activities. The role will be critical in supporting the growing needs of our internal...

Position Summary: As Laboratory Director, you are responsible for the overall operation and administration of the clinical laboratory, ensuring that the laboratory develops and uses a quality system approach to laboratory testing that provides accurate and reliable patient test results. You will manage all laboratory policies, processes, procedures, and resources needed to achieve consistent,...

Precision is looking for a Sr. Clinical Data Manager to join our client and will be responsible for supportive oversight of clinical data management activities for assigned programs. The successful candidate will proactively support LCDM(s) in the execution of Internal and CRO outsourced trials from study startup through study closure of trial objectives and corporate goals. Strong communication...

ONCOLOGY EXPERIENCE REQUIRED. The position provides oversight on clinical studies and provides statistical support on the development of in-house clinical studies and projects. The positional is responsible for designing, implementing, and reporting in a quality, timely and accurate manner, the statistical processes in clinical trials, including applying state of the art concepts and tools to the...

The Principal Scientist/Associate Director of ADME/Toxicology is accountable for planning, oversight, and delivery of nonclinical toxicology, ADME, and pharmacokinetics data packages in support of preclinical and clinical stage targeted alpha therapeutics. This role will report to the Director of Preclinical Development. Duties & Responsibilities: • Apply a broad understanding of toxicology,...

In this role, the incumbent will report to the Vice President, Early-Stage Clinical Development & Clinical Research and help develop clinical programs. In doing so, the Director will lead an interdisciplinary team to support the development of novel clinically meaningful surrogate endpoints and serve as a scientific resource to cross-functional internal teams to facilitate study execution. Key...

We are seeking a motivated Scientist/Senior Scientist to lead our biophysical characterization and protein analytics efforts in developing new and novel molecules for therapeutic applications. The successful candidate will provide guidance and data-driven support for the nomination of drug product candidates for preclinical development. The Scientist/Senior Scientist will have hands-on experience...

Our client is seeking Research Associates for their Massachusetts and Florida locations. These roles will be important members of the Research Group, responsible for conducting routine and semi-complex experiments and applying relevant knowledge and techniques to support the Scientific staff. Duties and Responsibilities: Essential duties and responsibilities include the following: • Conduct...

Key responsibilities: • Drive Immunology projects: generate target hypothesis, build data package, and evaluate potential therapeutics • Execute in vitro experiments to investigate target mechanisms of action • Lead in vivo proof of concept studies • Organize and report experimental results for discussion • Supervise junior scientists if applicable • Collaborate with...