The Department of Pharmacology and Toxicology within Developmental Sciences is seeking an experienced study monitor to support the contracting, preparation, conduct, monitoring and timely finalization of toxicology and research studies with our CROs partners. The successful candidate will use drug development and regulatory expertise to play an important role in the development of gene therapies to address the high unmet medical need in rare and ultrarare diseases and rapidly advance early assets through the pipeline.
To this extent, the individual will effectively perform the duties of a study monitor including but not limited to: study design and protocol development in collaboration with functional area representatives, comprehensive CRO oversight, reviewing reports and study related communications for content and accuracy; participate on study teams as needed; coordinate test article shipping; and document archiving, communicate effectively across multiple functional areas and programs. Individual must have strong understanding of science, GLP regulations, and preclinical CRO landscape.
Education and Experience Requirements
- Manage outsourcing of preclinical studies (GLP and non-GLP) for inclusion in regulatory submissions, including but not limited to pharmacology, toxicology, and biodistribution studies.
- Effectively manage, develop, track project timelines of nonclinical outsourced studies.
- Independently edits and reviews documents such as study protocols, protocol amendments, reports, SEND datasets, and other study supporting documents for consistency, completeness, and accuracy.
- Generate and submit study designs to CROs and obtain competitive bids and timelines and negotiate as appropriate.
- Maintain and initiate relationships with established and new CROs based on business needs.
- Conduct feasibility assessments and participate in the selection of new CROs. Facilitate discussions with CRO personnel and Spark SMEs as needed.
- Interface effectively with CMC and Supply Chain to manage test article supplies, orders and shipping.
- Help manage the Master Schedule for external preclinical studies.
- Independently supports multiple programs with a strong understanding of disease indication, MOA, clinical strategy, and target profile.
- Participate in regular teleconferences with CROs including but not limited to: pre-study meetings, bi-weekly/monthly CRO program meetings, operational, and pre-reporting ("tox/path") meetings.
- Effectively negotiates and facilitates open communication across all departments.
- Understands dynamic global CRO landscape and proactively leverage knowledge to address business needs.
- Understand business needs with respect to nonclinical outsourcing strategies and GLP compliance goals.
- Solid understanding of documents governing inspection readiness.
- Provides support during regulatory inspections and internal functional group audits.
- Ability to travel for study monitoring.
Other Job Requirements
- Bachelor or higher degree in scientific or quality-related field.
At least 8 years of industry experience preferably working at a pharmaceutical company and/or CRO.
- Previous GLP experience in pharmaceutical, biotechnology industry, CRO or equivalent GXP transferable experience. Knowledge of global regulatory guidelines (ICH/GLP/OECD) is a plus.
- Solid understanding of drug development, study design, data management systems, procedures and documentation practices.
- Effective communicator both verbally and in writing.
- Must be detail oriented, with ability to multi-task and work in both an individual and team-based environment.
- Excellent interpersonal, organizational and problem-solving skills required.
- Ability to influence and negotiate effective solutions.
- Proficient with MS Office and Acrobat Reader in PC/Mac. Good understanding of other computer systems a plus.
Travel required up to 25% of the time.
- Ability to travel for study monitoring (around 25%)
Please be aware that Spark mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law.
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We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable - until now.
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