Pre-Clinical Senior Study Director- Infectious Disease Research

27 سبتمبر، 2022

0 2 5 دقائق

الوصف الوظيفي

PRE-CLINICAL SENIOR STUDY DIRECTOR – 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 senior study director monitors project work for timely completion, deliverables, budget maintenance, and quality standards. This position analyzes and reports results for publication or to sponsor; provides instruction to other members of the project team; collaborates with other senior members of the staff on projects/research, and provides training to others as necessary. The senior study director provides coverage for client-facing activities and communications. The position works closely with assigned project team members and related management for studies. Individual 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. The senior study director is the highest level of individual contributor and is knowledgeable of emerging trends and may contribute to and influence best practice within discipline. Position serves as technical lead for project proposals.
Essential Duties & Key Responsibilities

Performs role of study director (SD) and scientific subject matter expert (SME) on infectious disease projects.
Develops in vivo and in vitro experimental study designs for vaccines and therapeutics
Acts as a key scientific resource and point of control for our clients.
Directs and oversees in vivo and/or in vitro studies, assay development/validation and other experiments conducted in operations.
Partners with business development, project management, and proposals to ensure successful client engagement, proposal development, study execution, and deliverables upon study completion.
In collaboration with business development, client engagement and marketing, develops new service offerings according to market need.
Within defined policies and procedures, provides resolution to complex scientific problems within a specified program.
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.
Oversees and serves as a technical advisor for lab operations to execute assay development and validation experiments.
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.
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.
Supports troubleshooting assay issues in validation and sample analysis.
Participates in proposal generation and performs scientific/technical review.
Follows GLP practices to ensure all experimental data, including observations of unanticipated responses are accurately recorded and verified.
Ensures compliance to all regulatory and safety requirements for work including select agents.
Observes appropriate safety and study requirements by reading, understanding, and following Standard Operating Procedures (SOPs), GLP requirements, and study protocols.
Is accountable for some level of revenue generation.
Completes data analysis and prepares study reports.
Authors, updates, and/or reviews area-specific Standard Operating Procedures (SOPs), ensuring that SOP reflect current practices.
May be asked to serve as system administrator, assists on validation teams, ad hoc committees, represent at internal meetings, or contact sponsors regarding study specific issues.

Requirements/Minimum Qualifications

PhD in life sciences discipline or DVM plus at least 4 years' relevant experience or Master's degree in life sciences plus at least 10 years' relevant experience
Proven track record of leading large commercial or government proposal generation and securement of funding.
Has advanced the field of knowledge in his/her specialty with strong publication record and patents. Work directly impacts the present or future of the organization in significant ways.
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, and monkeys.
Demonstrated work experience and competence in executing in vivo and in vitro studies in a GLP-compliant environment.
Presentation and statistical analysis of data.
Proficient in assay development/qualification and directing/mentoring validation methodologies for clinical trial support in a GLP environment.
Must demonstrate full competency under regulated environment (e.g. GLP, BSL-3/SA).
Ability to work in A/BSL-1, 2, and 3 environments.
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.