Early Development Team Leader Jobs

Be available for 100% remote working with occasional office visits based on manager discretion.

Must have big pharma experience working in clinical development

Must have experience leading and driving compound development strategy

Must have clinical development experience in oncology or immunology

Be West coast based ideally but able to work anywhere in US.

Preference will be given to candidates based on west coast. (Our headquarters is in San Diego)

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

Knowledge and experience with quality management methodologies.

Knowledge and experience of project management concepts, techniques and processes.

Demonstrated analytical and information technology skills (project management, document management, and finance management).

Alliance and external partner relationship management experience.

Skilled in budget, expense management, cost estimation and cost efficiencies.

In accordance with corporate standards, implements project management processes, tools, and templates to facilitate the management of project activities including:

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

Lifecycle management experience is required.

Collaborate closely with Program Management to identify and allocate appropriate resources (FTEs and budget) to support the program.

West coast based ideal, but able to work anywhere in US. 100% remote with occasional office visits based on manager discretion.

Manage the complexity of internal/external development activities and proactively identifying issues and risks while leading contingency planning and problem solving.

Must have big pharma experience working in clinical development

Must have experience leading and driving compound development strategy - please dig into this

Strong project management, process orientation, and influencing/conflict management skills

Solid people management experience and demonstrated success in building/leading a team

Collaborate with EHS leadership to ensure the safety of employees and appropriate management of contractors

Location, confirmed job-related skills and experience will be considered in setting actual starting salary

Work together with department managers to ensure project addresses sites recommendations and concerns

Work with Project Team/Consultation Firm to define site requirements and project stages

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.

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

Experience as an effective mentor. Line management experience highly preferred

Working with the Finance group to implement and track program budget.

Implement initiatives to support development and scaling of capabilities, tools and processes.

Collaboration with finance stakeholders to support tracking of actuals to budget, communicate deviations and identify variations;

12+ years’ industry experience, with deep experience managing early Clinical Development projects in pharmaceutical or Biotech Company

Experience of drug development in oncology strongly preferred