Early Development Lead Jobs

Lead protocol development of the new processes, batch record template set-up, set-up batch record management system, raw material inventory, etc.

A minimum of 6 years of industry experience genetic nanomedicine working with nanocarrier formulation and delivery.

Prior experience in non-viral delivery systems – formulation, process and analytics is essential.

Develop and harmonize scaled-up processes to enable single run of non-viral nanocarriers for RNA batch size of 10mg and beyond.

Work as a team member in development to build platforms that can provide material and information for tox studies,

Work as a team member in development working on CMC deliverable for various portfolio assets

Performs site management activities to ensure compliance to the protocol, monitoring plan, GCP, ICH, applicable federal/local regulations, and SOPs

Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements

Conducts site qualification, initiation, interim, and close-out visits

Performs drug accountability, reconciliation, and destruction. Verifies storage and shipment requirements are according to protocol

Travels to clinical study sites as required, including remote or onsite visits globally

Analytical problem-solving experience, trouble shooting and resourcefulness

Ensures timely and transparent and objective communications about program status and issues between IPT and management;

Evidence of ability to lead and manage a team to deliver to time, cost and quality requirements.

Comprehensive knowledge of scientific, development and regulatory landscape to enable state-of-the-art development strategies for all assets;

Board certification within oncology/hematology or associated subspecialties;

Relevant global health authority interactions and current knowledge of regulatory review and responses;

Excellent communication and leadership skills, coupled with the ability to develop and implement a strategic growth plan;

We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.

Relevant experience (minimum of 5 years; 8+ years preferred) in an academic, hospital, or pharmaceutical/biotech setting.

Strong scientific background in oncology drug development (basic, translational, and/or clinical); and experience in designing and/or conducting oncology clinical trails.

Experience leading a team in a cross-functional environment, preferably with global scope.

Strong collaboration, facilitative leadership, executive function, and problem-solving skills.

Excellent oral and written English communication skills.

Proficient computer skills and knowledge of Microsoft Office programs, familiarity with Internet.

Excellent customer service skills, including written and verbal communication abilities.

Maintain current knowledge of local, state and federal laws, regulations, policies and procedures.

Facilitate initial intake and form requirements for prospective students. Ensure that everything is accurate and complete.

Previous experience in an early childhood development facility preferred

Previous childcare billing experience preferred

4 years of experience in Electrical Design of large power plants or industrial facilities

Minimum of a bachelor's degree in a related field

Must be able to travel into the office 2x a week and 20% travel is required across the nation