Pre-Clinical Study Director 2 – Infectious Disease Research

27 سبتمبر، 2022

0 2 5 دقائق

الوصف الوظيفي

PRE-CLINICAL STUDY DIRECTOR 2 – INFECTIOUS DISEASE RESEARCH
General Summary
The position functions as study director and subject matter expert on commercial and government contracts and has oversight of the scientific elements of projects to ensure successful completion and/or implementation in the area of emerging viral infectious diseases. The study director 2 monitors project work for timely completion, deliverables, and quality standards. Individuals in this role work independently on studies; compiling and evaluating data, assembling study files and reports for publication or to sponsor; provide instruction to other members of the project team; and collaborate with other senior members of the staff on projects/research. The study director 2 acts as a key point of scientific control for our clients and will often interact with clients. The position works closely with assigned project team members and related management for studies. The study director 2 is fully trained in the position's key responsibilities as it applies to work areas and may require training on new processes as they arise. May provide training to others as necessary, to conduct similar project execution. Position serves as technical leads for project proposals.
Essential Duties and Responsibilities

Performs role of study director (SD) and scientific subject matter expert (SME) on infectious disease projects.
Performs in vivo and in vitro experimental study design for vaccines and therapeutics and interacts with clients.
Drafts protocols, amendments, and departmental notifications for projects; formats documents for correct grammar, punctuation, consistency in format and style, and adherence to regulatory requirements and contract language.
May create and maintain the study file (electronic) and/or study binders (hard copy).
May create and maintain the ACUP and BPR as needed.
Distributes study protocols, amendments, and departmental notifications; prepares/reviews data collection systems/forms as needed; schedules and conducts pre-study meetings.
Ensures that the protocol and/or scope of work reflects the contract.
Identifies and incorporates exceptions to GLP conduct into GLP study protocols as applicable (e.g., systems/processes that are not validated).
Submits protocols, study records, and applicable data/reports to QA for review; manages and coordinates completion of audit responses.
Completes review of Standard Operating Procedures (SOPs) associated with study conduct and incorporates appropriate language into the protocol when necessary to provide detail on procedures not included.
Reviews contract for use in execution of studies and proactively notifies Project Manager of any issues.
Sets up or requests the creation of Provantis study files for applicable studies.
Performs review of Provantis study setups prior to providing approval for use.
Works closely with the scheduling staff and department leadership to ensure project work is scheduled appropriately to meet customer timelines.
Collaborates with project team members and related management to support study execution.
Submits requisitions as necessary, Communicates and approves purchase requisitions as necessary.
Provides coverage for client-facing activities.
Performs/documents study inspections and presents findings as applicable.
Prepares or reviews data for processing and reporting; ensures quality control is performed and corrections are made in accordance with deadlines.
Reviews software programs, forms, and/or data for missing, inaccurate, or improbable results and for adherence to regulatory and/or client requirements; may aid in resolving data collection problems as needed.
Assists in preparation of study reports or contributing scientist reports.
Assists in the training of others as applicable.
Authors, updates, and/or reviews area-specific Standard Operating Procedures (SOPs), ensuring that SOPs reflect current practices.
May be asked to serve as system administrator, assist on validation teams, ad hoc committees, represent at internal meetings, or contact sponsors regarding study specific issues.
Works closely with study coordinator and/or project manager as technical SME on assigned projects and will interface with client's scientific staff as appropriate.
Develops assays; completes study designs for infectious diseases in vitro and/or in vivo studies.
Oversees and serves as a technical advisor for lab operations to execute assay development and validation experiments.
Supports troubleshooting assay issues in validation and sample analysis.
Reviews data from sample analyses and interpret Contributing Scientist Reports (CSR).
May participate in proposal generation and perform scientific/technical review.
Follows GLP practices to ensure all experimental data, including observations of unanticipated responses are accurately recorded and verified.
Performs all work tasks following laboratory safety requirements including A/BSL-3 and select agent.
Ensures compliance to all regulatory and safety requirements for work with select agents.
Observes appropriate safety and study requirements by reading, understanding, and following Standard Operating Procedures (SOP), Good Laboratory Practice (GLP) requirements, and study protocols.
Participates in required select agent training as appropriate. Conducts or oversees virology studies and assay development/validation experiments.
Partners with Business Development, Project Management, and Proposals to ensure successful client engagement, proposal development, study execution, and deliverables upon study completion.
Executes IR&D studies for new pipeline development.

Requirements/Minimum Qualifications

PhD in life sciences discipline or DVM with at least 2 year's relevant experience or Master's degree in life sciences with 8 years' relevant experience or Bachelor's degree in life sciences with 11 year's relevant experience.
Have a recognized standing in their specialty with strong publication record and are known for their innovation and creativity in areas supporting the organization's mission.
Broad experience in infectious disease research with in vitro and in vivo models is a must.
Prior experience with Immunogenicity and efficacy testing in animal models such as mice, ferrets, hamsters, monkeys
Proficient in assay development methodologies.
Ability to work in A/BSL-1,2, and 3 environments
Prior experience with A/BSL-1,2 and 3 and handling of select agent is preferred.
Ability to coordinate the work of others to meet project objectives and deadlines.
Ability to interact with others in a cooperative, persuasive, and tactful manner.
Ability to read, understand, retain, and apply knowledge of Good Laboratory Practices (GLP) and other study requirements.
Prior demonstrated experience in in vivo studies for evaluating vaccines and therapeutics.
Demonstrated work experience and competence in executing in vivo and in vitro studies in a GLP-compliant environment.
Effective verbal and written communication skills including correct grammar, spelling, and punctuation.
Highly detail oriented; possesses good planning, organization, task efficiency, and time management skills.
Ability to conduct and manage meetings/trainings effectively.
Working knowledge of or the ability to learn and utilize specialty software applications (e.g., Edstrom, laboratory information management systems, etc.)
Must be eligible to work in the United States without employer sponsorship.

Organizational Core Values
Cultivating human connection – putting people first. We know that every individual makes a difference and that no one can do it alone. We believe the world's most powerful resource is human potential. We are an inclusive and courageous team where innovation and diversity of though go hand in hand. We understand that relationships move at the speed of trust.
Operating with precise execution – measuring what matters and owning results as a team. We leverage data to drive decisions that advance science. We recognize the importance of a stable foundation coupled with an agile mindset. We hold ourselves accountable and take pride in our work. We give and receive candid feedback as a gift that keeps us growing.
Harnessing relentless curiosity – our unstoppable, innovative force. We are driven to ask sharp questions and push the boundaries of knowledge. We use creativity and critical thinking as catalysts for finding solutions that change lives. We learn by doing, consistently striving to improve our relationships, training, methodologies, questions and results.
Stewarding a healthy community – implementing sustainable operations for a safe, engaging environment. We don't compromise on safety and health for our employees, customers or community. We believe a healthy community begins with inclusive economic opportunities. We respect the dignity of the patients we ultimately serve. We are motivated to serve communities that are underserved and markets that are overlooked.
Work Environment & Conditions
This position works in a laboratory environment (A/BSL-1, 2, & 3) and requires the use of personal protective equipment (PPE) including (but not limited to):

Eye protection (Safety glasses and/or full-face shield)
Respirator (varies based on tasks and barrier requirements)
Tyvek/scrub suits
Nitrile (or equivalent) gloves (varies based on tasks)
Hearing protection (varies based on tasks)

Immunizations are required for this position and are determined by the study/agent. Some examples include Tetanus, Hepatitis B, Smallpox, Polio, and Influenza.