Open To Work
Hi, I’m
Elizabeth S. Crawley
Fortville,IN
Overview
23
years of professional experience
Work History
Dechra
Senior Scientist Product Development
01.2024 - Current
Job overview
- Developed and implemented innovative ideas in the clinical development of novel veterinary biotherapeutic products through the design, execution and reporting of laboratory pharmacokinetic, safety(immunogenicity), and client-owned animal field studies.
- Accountable for objectives, timelines, budget, and risk management.
- Served as the Subject Matter Expert for PK, immunogenicity, and bio-assay development for all large molecule projects in Dechra’s pipeline including external collaborator partnerships.
- Collaborate with Regulatory Affairs to ensure new animal biotherapeutic drug products met required regulations.
- Worked with the FDA Center for Veterinary Medicine (FDA-CVM) and helped prepare development programs and registration materials for Medicines Association (EMA) agencies.
- Authored global regulatory submissions to support the development and approval of biotherapeutics in animal health.
- Performed due diligence for multiple external opportunities, mostly focused in the biotherapeutic innovation area.
- Collaborate with external partners to design and implement experiments to validate possible new therapy modalities and support de-risking strategies ahead of proof-of-concept research.
- Remote (UK based company)
Telix RadiopharmaceuticalsFishers, IN
Senior Manager Pharmacology & Toxicology
01.2022 - 01.2024
Job overview
- Provide scientific and technical leadership to Telix’s entire pipeline; design and implement the non-clinical drug development studies and regulatory strategies with a focus on shortening time to deliver theragnostic to patients without compromising safety or quality.
- Lead immunogenicity efforts in the Clinical programs; develop and deliver regulatory compliant clinical immunogenicity assessment strategies for drug candidates.
- Spearhead and implement the global Animal Welfare Policy for Telix and manage 3R oversight for all animal-based research.
- Build a global network of trusted CRO partners and oversee the outsourced study work.
- Engage in scientific conferences that would enable exposure to new radiopharmaceutical assets and build networking in the emerging area of radio-therapeutic oncology diagnostics and treatment space.
- Author global regulatory documents including IND, CTA, BLA, IB, and contribute to written and in person communications with regulatory agencies that allowed for accelerated review/approval.
ElancoGreenfield, IN
Advisor; Large Molecule Bioanalytical Strategy
01.2019 - 01.2021
Job overview
- Identify and select CROs and establish contract agreements to support all external large molecule bio-analytical work supporting the entire Elanco large molecule pipeline.
- I was solely responsible for establishing the large molecule bioanalytical outsourcing strategy for all of Elanco.
- Coordinate, supervise and/or monitor study activities and collaborator efforts as necessary and consistently build and foster external relationships to ensure high quality data results and outputs.
- I am always swift to assist in propelling the pipeline forward by being a study director for several large molecule drug candidates even when it is not considered as part of my current role.
- Consistently demonstrate innovative approaches and a process improvement mindset.
- Designed, executed, and analyzed a novel immunogenicity de-risking strategy with the intent that it would be submitted to global regulatory authorities in an undefined space in animal health.
- I developed a novel approach to utilize internal vaccine resources to generate.
- Routinely work cross-functionally across Elanco to complete tasks outside traditional R&D work.
- I collaborated with HR, marketing, finance, IT and sales as the project manager to implement a US-based employee pet medicine discount program that did not previously exist at Elanco.
- Serve as an external ambassador for Elanco.
- I have been invited to represent Elanco at both college recruitment fairs and the national FFA convention.
- I was an invited speaker at the 23rd International REID Bioanalytical Forum and presented on differences between the drug development process in human and animal health.
ElancoGreenfield, IN
Senior Scientist, Companion Animal ADME & Clinical Efficacy
01.2013 - 01.2019
Job overview
- Designed comprehensive research programs (Design/develop protocols, data analysis and clinical study reports) to assess Effectiveness and Clinical Field Safety as well as PK/PD for predominately equine and canine products.
- I was responsible for running the largest clinical field study to date at Elanco to test the efficacy of a parasiticide throughout the United States.
- Designed and executed global PK/PD and efficacy studies for parasiticide drug candidates in canines.
- I presented a PK/PD model to the CVM that allowed for a reduced efficacy study data package.
- This innovative approach allowed Elanco to save time to market, overall budget, and respected the 3Rs initiative of animal use.
- Lead and coordinated the design and approval of eCRFs for several efficacy and clinical trial data collection projects.
- I was the main point of contact for developing and testing a novel electronic data capture system that supported an entire (successful) pivotal efficacy and clinical trial data drug submission package.
- Prepared global efficacy, safety, ADME technical sections in partnership with Elanco Regulatory Affairs.
- I have been a contributing author on regulatory submissions on both drugs in the current pipeline and drugs that are now commercially-approved animal health products.
- Managed project timelines and budget deliverables to facilitate delivery of the Elanco pipeline.
- I consistently provided innovative solutions that saved company resources or reduced time to market on developmental research plans.
- Worked effectively and flexibly within and across all Elanco R&D teams and external collaborators to consistently achieve overall Elanco R&D deliverables.
ElancoGreenfield, IN
Senior Scientist, Companion Animal ADME & Clinical Efficacy
01.2012 - 01.2013
Job overview
- Partnered with other Elanco/Lilly Quality organizations to ensure GXP compliance was achieved (GLP, GCP, GMP, etc.)
- Provided clear, accurate and consistent quality compliance guidance using a broad-based knowledge of veterinary pharmaceutical and biologics development and commercialization.
- Supported CR0 and Investigator site qualification activities including regulatory audits and QA oversight for protocols, data analysis, and regulatory reports to ensure quality data output and adherence to global regulatory guidelines.
Eli Lilly and CompanyIndianapolis, IN
ADME Scientist, Biotherapeutics
01.2007 - 01.2012
Job overview
- Responsible for the design, conduct, analysis, interpretation, and reporting of studies of investigative biotherapeutics.
- Wrote and modified protocols, methods, procedures, guidelines, and data summaries.
- Reviewed data and reports from Contract Research Organizations (CROs), and facilitated transfer of in-house work with internal and external customers to ensure deadlines and expectations were met.
- Conducted research to develop, validate, implement, and/or approve assays used for quantification of compounds or biomarkers including performing bio-analytical analysis for pre-clinical thru Phase 1 Human Clinical Trials.
- Routinely collaborated with senior scientist to analyze and prepare data for team meetings or governance committees, presented data at internal forums, and prepared graphs and tables to effectively interpret and communicate data including Investigator Brochures (IBs) & Common Technical Document (CTD).
Eli Lilly and CompanyGreenfield, IN
In-vivo Pharmacology Technician
01.2003 - 01.2007
Job overview
- Coordinated and lead the conduct of the ADME live phase pre-clinical research efforts for biotherapeutics.
- Conducted live phase GLP Developmental and Reproductive Toxicology studies.
- Frequently educated scientists, supervisors, and technicians in study design logistics and was responsible for training employees on all technical procedures.
- Mastered a wide variety of technical expertise and diversity; specialization in Pharmacokinetic sampling, tissue collection, handling radioactive materials, blood brain barrier transporter work, and use of specialized disease models.
Timeline
Senior Scientist Product Development
Dechra
01.2024 - Current
Senior Manager Pharmacology & Toxicology
Telix Radiopharmaceuticals
01.2022 - 01.2024
Advisor; Large Molecule Bioanalytical Strategy
Elanco
01.2019 - 01.2021
Senior Scientist, Companion Animal ADME & Clinical Efficacy
Elanco
01.2013 - 01.2019
Senior Scientist, Companion Animal ADME & Clinical Efficacy
Elanco
01.2012 - 01.2013
ADME Scientist, Biotherapeutics
Eli Lilly and Company
01.2007 - 01.2012
In-vivo Pharmacology Technician
Eli Lilly and Company
01.2003 - 01.2007