- Serves as Study Director on toxicology, biodistribution, pharmacokinetic, and related studies to ensure study execution, client engagement, and deliverables upon study completion.
- Provides nonclinical expertise to a cross-functional project team.
- Partners with business development and project management to generate proposals and costings for new work.
- Works with internal functional areas to ensure all studies are performed in a quality, timely, and scientific manner.
- Drafts protocols, amendments, departmental notifications, and study comments forms, ensuring correct grammar, punctuation, consistency in format and style, and adherence to regulatory requirements and contract language.
- Follows GLP and other appropriate regulatory (e.g., OECD, ICH) requirements to ensure all experimental data, are accurately recorded and verified.
- Authors, updates, and/or reviews area-specific SOP's, ensuring that SOP's reflect current practices.
- Manages studies within time and budget constraints.
- Participates in continual improvement initiatives.
- Bachelors degree in life sciences related field with 5 years of experience or masters degree in related field with 2 years of experience or PhD; or an equivalent combination of education and or experience in a related field.
- Work within a GLP or similarly regulated environment.
- Excellent communication skills, with attention to detail, with the proven ability to build open and collaborative relationships and work effectively as a member of a multidisciplinary team.
- Excellent time management and organizational skills. Proven ability to handle multiple and changing priorities.
- Experience in the preparation and review of regulatory documents including writing the nonclinical safety assessment portion of regulatory documents.
- Experience creating and presenting scientific presentation and publications.
- Able and willing to work in a biosafety level 2 (BSL2) environment and wear appropriate PPE.
- Role will require immunization with FDA licensed vaccines and Investigational New Drugs (IND) recommended for persons at risk to occupational exposure of biological agents.
- Health, Dental, and Vision insurance that starts on your first day at AmplifyBio
- Competitive Compensation Package
- We take work-life balance seriously and we back it up with a FLEXIBLE PTO policy
- Generous paid parental leave
- Wellness and Self-Care Programs
- 401(k) match
- Tuition Reimbursement
- EAP/work-life support system
- A fun work environment where everyones voice matters
- We are just getting started More benefits on the way
- An Opportunity to Change the World
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Study Director - West Jefferson, United States - AmplifyBio
Description
Are you passionate about significantly improving the future of medicine? Do you believe that people are the most important asset of any company? If so, join AmplifyBio
AmplifyBio is a leading contract research organization with a comprehensive range of services that span from being an outsourcing partner for discovery stage R&D work, a preclinical CRO performing safety efficacy and toxicology studies for small molecules and advanced therapies alike, and, most recently, an expansion into manufacturing services for cell, gene, and mRNA-based therapeutics.
The AmplifyBio ecosystem is comprised of three distinct business units: ADOC (South San Francisco, CA) Amplify's Discovery, Optimization, and Characterization laboratories: ASET (West Jefferson, OH) Amplify's Safety, Efficacy, and Toxicology Site; and the most recently opened AMEC (New Albany, OH) Amplify's Manufacturing Enablement Center.
About ASET West Jefferson, OH: AmplifyBios safety, efficacy, and toxicology unit (ASET) was launched as a preclinical CRO that spun out of Battelle in 2021 to address the changing needs of commercial organizations developing modern therapeutics. AmplifyBio brings decades of experience to accommodate a wide variety of GLP and non-GLP studies in all in vivo models and dose routes. Among the investments that AmplifyBio has made to empower preclinical assessments of advanced therapies is building a new state-of-the-art analytical laboratory to include molecular and immunological assays that assess critical safety and efficacy indicators for cell and gene therapies during preclinical studies
AmplifyBio is seeking to hire a Study Director to join our growing team
The Study Director has oversight of the scientific elements of projects to ensure successful implementation and/or study completion of non-clinical studies. The individual filling this position must be knowledgeable of emerging trends and may contribute to and influence best practices within the discipline. This individual will analyze, and report results to our clients, provide scientific instruction to other members of the project team, and collaborate with other senior members of the staff on projects research. The individual is responsible for the organization, management, and business performance of the projects they will be assigned.
What Youll Do Here:
We Would Love to Hear from You If:
At AmplifyBio, we're committed to growing and empowering an inclusive community within our company and industry. This is why we hire and cultivate diverse teams of the best and brightest from all backgrounds, experiences, and perspectives across our organization.
AmplifyBio is an equal opportunity employer, and we value diversity at our company. We don't discriminate on the basis of race, color, citizenship status, national origin, ancestry, gender (including gender expression and gender identity), sexual orientation, age, weight, religion, creed, physical or mental disability, marital status, veteran status, political affiliation, or any other factor protected by federal, state, or local law.
Why You Will Love Working Here:
We take the health and happiness of our employees seriously and consistently evaluate new ways to Amp up our benefits to provide an amazing place to work. From a wellness program (did we mention we have an onsite gym with state-of-the-art equipment and ping pong table?), to financial planning and legal assistance, we make sure to take care of our own.
When you join our team, you will be a part of groundbreaking work while collaborating with our clients, research scientists, study directors, lab technicians, and specialists across a variety of disciplines. The future for AmplifyBio is as great as the combination of our imaginations and actions, and we hold ourselves accountable for our choices and results. We have a bias for action, excellence, and, especially, the health and safety of our employees.
