Study Director

13 hours ago

Reston, Virginia, United States AmplifyBio Full time
About the Role

We are seeking a highly skilled Study Director to join our team at AmplifyBio, a leading contract research organization. As a Study Director, you will be responsible for overseeing the scientific elements of projects, ensuring successful implementation and completion of non-clinical studies.

Key Responsibilities
  • Lead toxicology, biodistribution, pharmacokinetic, and related studies to ensure study execution, client engagement, and deliverables upon study completion.
  • Provide nonclinical expertise to a cross-functional project team.
  • Partner with business development and project management to generate proposals and costings for new work.
  • Work with internal functional areas to ensure all studies are performed in a quality, timely, and scientific manner.
  • Draft 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.
  • Follow GLP and other appropriate regulatory (e.g., OECD, ICH) requirements to ensure all experimental data are accurately recorded and verified.
  • Author, update, and/or review area-specific SOPs, ensuring that SOPs reflect current practices.
  • Manage studies within time and budget constraints.
  • Participate in continual improvement initiatives.
Requirements
  • Bachelor's degree in life sciences-related field with 5 years of experience or master's 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 presentations 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.
What We Offer
  • Competitive compensation package.
  • Health, dental, and vision insurance that starts on your first day at AmplifyBio.
  • 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 everyone's voice matters.
About 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: AmplifyBio's 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.

  • Biostatistics Director

    4 days ago

    Reston, Virginia, United States Proclinical Staffing Full time

    Biostatistics Director - Permanent PositionProclinical Staffing is seeking a highly skilled Biostatistics Director to join a leading biopharmaceutical company. Key Responsibilities:This role offers the opportunity to significantly influence the design and analysis of pivotal clinical studies, contributing to life-changing therapies for rare diseases. You...

  • Director/Senior Director, Translational Biomarkers

    2 days ago

    Reston, Virginia, United States Phaidon International Full time

    Job Title: Director/Senior Director, Translational BiomarkersBase Salary: $170,000 - $235,000 (with additional Bonus and Equity)Phaidon International is currently partnering with several industry-leading Pharmaceutical companies to seek strong leaders in the field of Translational Biomarkers. As a leader in the Preclinical and Translational Sciences team,...

  • Clinical Operations Director

    16 hours ago

    Reston, Virginia, United States Meet Full time

    Associate Director Clinical OperationsThe Associate Director of Clinical Operations plays a pivotal role in overseeing the planning, coordination, and execution of global clinical trials. This position is responsible for ensuring adherence to project milestones, managing financial aspects, and upholding quality standards in line with ICH/GCP guidelines,...

  • Senior Director of Biostatistics

    15 hours ago

    Reston, Virginia, United States Penfield Search Partners Ltd Full time

    Senior Director of BiostatisticsPenfield Search Partners Ltd is seeking a highly skilled Senior Director of Biostatistics to join our team. As a key member of our organization, you will be responsible for providing statistical input and support for clinical trial design, conduct data analysis, and results interpretation.Key Responsibilities:Provide...

  • Director of Pharmacokinetics and Clinical Pharmacology

    1 week ago

    Reston, Virginia, United States Recruits Lab (We're hiring) Full time

    About the RoleWe are seeking a highly experienced and skilled Director/Senior Director of Pharmacokinetics and Clinical Pharmacology to join our team at Recruits Lab. This is a key leadership position that will play a pivotal role in shaping the future of oncology medicine.Key ResponsibilitiesProvide expert guidance on all aspects of clinical pharmacology...

  • Clinical Development Director

    2 days ago

    Reston, Virginia, United States Biopretium Full time

    {"title": "Clinical Development Director", "content": "Job SummaryBiopretium is seeking a highly experienced Clinical Development Director to lead the strategic direction, planning, and execution of clinical development programs. This role is responsible for overseeing the design and execution of clinical studies, ensuring compliance with medical and...

  • Director of Pharmacokinetics and Clinical Pharmacology

    11 hours ago

    Reston, Virginia, United States Recruits Lab (We're hiring) Full time

    Transformative Opportunity in Precision Medicine OncologyWe are seeking a visionary Director/Senior Director of Pharmacokinetics and Clinical Pharmacology to spearhead the development of next-generation oncology therapies at our client, a trailblazer in precision medicine oncology.About the Role:Strategic Leadership: Oversee clinical pharmacology studies,...

  • Director of Pharmacokinetics and Clinical Pharmacology

    5 days ago

    Reston, Virginia, United States Recruits Lab (We're hiring) Full time

    Transformative Leadership Opportunity in Precision Medicine OncologyRecruits Lab is seeking a visionary Director/Senior Director of Pharmacokinetics and Clinical Pharmacology to join our client, a pioneering company in precision medicine oncology, in South San Francisco, California.About Our Client:This forward-thinking organization is at the forefront of...

  • Senior Medical Director

    2 weeks ago

    Reston, Virginia, United States Biopretium Full time

    Job Title: Senior Medical Director - OncologyLocation: Hybrid work environment with offices in various locations.Reporting Line: Reporting into the Chief Medical OfficerCompany Overview:Biopretium is a biotech company founded in 2014 with headquarters in Washington state. We specialize in developing therapies for oncology indications and have a substantial...

  • Executive Medical Director

    4 days ago

    Reston, Virginia, United States Biopretium Full time

    Job Title: Senior Medical Director - OncologyLocation: Hybrid work environment with offices in various locations.Reporting Line: Reporting into the Chief Medical OfficerCompany Overview:Biopretium is a biotech company founded in 2014 with headquarters in Washington state. Our company focuses on the development of therapies for oncology indications. With a...

  • Senior Director, Clinical Supply Chain Management

    2 days ago

    Reston, Virginia, United States SciPro Full time

    Job SummarySciPro is seeking a highly experienced Senior Director, Clinical Supply Chain Management to join our team. As a key member of our Clinical Supply Chain organization, you will be responsible for coordinating end-to-end supply chain management on multiple clinical programs.Key ResponsibilitiesSupply Chain Planning: Partner with Clinical Operations...

  • Senior Director of Translational Biomarkers

    16 hours ago

    Reston, Virginia, United States Phaidon International Full time

    Job Title: Director to Senior DirectorBase Salary: $170,000 - $235,000 (with additional Bonus and Equity)Phaidon International is partnering with a well-funded genetic medicines company to find a strong leader in the field of Translational Biomarkers. As a member of the Preclinical and Translational Sciences team, you will oversee support for several...

  • Director of Nonclinical Development Lead

    18 hours ago

    Reston, Virginia, United States Proclinical Staffing Full time

    Director of Nonclinical Development - Contract - BostonProclinical Staffing is seeking a seasoned professional to lead the Nonclinical Development function at a leading RNAi Therapeutics biotech with a rich pipeline of IND enabling programs.Key Responsibilities:This role is pivotal in driving nonclinical strategy and overseeing the execution of non-clinical...

  • Director of DMPK Research and Development

    2 weeks ago

    Reston, Virginia, United States BioPhase Full time

    About the RoleWe are seeking a highly motivated and experienced Director of DMPK to join our dynamic drug discovery and early development team at BioPhase. As a key member of our Preclinical R&D team, you will work closely with our DMPK, biology, and chemistry teams to drive early discovery research programs into early clinical development.Key...

  • Senior Director of Clinical Supply Chain Management

    16 hours ago

    Reston, Virginia, United States SciPro Full time

    Senior Director, Clinical Supply Chain ManagementAbout the RoleSciPro is seeking a highly experienced Senior Director, Clinical Supply Chain Management to join our Pharmaceutical Development organization. As a key member of our Clinical Supply Chain team, you will be responsible for coordinating end-to-end supply chain management on multiple clinical...

  • Clinical Scientist Director

    9 hours ago

    Reston, Virginia, United States Skills Alliance Full time

    Transformative Cancer TherapiesSkills Alliance is seeking a highly experienced Clinical Scientist Director to join our team dedicated to developing first-in-class and best-in-class targeted cancer therapies. Our portfolio pursues each target with a modality appropriate to its biology, including small molecules, ADCs, and RLTs.Position OverviewWe are looking...

  • Clinical Operations Director

    3 days ago

    Reston, Virginia, United States Meet Full time

    Job SummaryThe Associate Director of Clinical Operations is a key member of our team, responsible for overseeing the planning, coordination, and execution of global clinical trials. This role requires a strong understanding of industry practices, outsourcing, and GCP system requirements.Key ResponsibilitiesStudy Execution: Oversee clinical operations for...

  • Senior Director of In Vivo Pharmacology

    15 hours ago

    Reston, Virginia, United States Meet Full time

    We are seeking a highly skilled Senior Director of In Vivo Pharmacology to lead our research group in preclinical program development across in vivo pharmacology, supporting programs to successful IND application.Key Responsibilities:Develop and manage in vivo pharmacology programs, overseeing design, implementation, target validation, and translational...

  • School Director

    2 days ago

    Reston, Virginia, United States New Horizon Academy Full time

    About the RoleWe are seeking a highly skilled and experienced School Director to join our team at New Horizon Academy. As a School Director, you will be responsible for leading our early childhood education programs and ensuring the highest quality of care and education for our students.Key ResponsibilitiesLead and manage a team of educators and support...

  • Visiting Faculty/Coordinator of Legal Studies Community

    3 weeks ago

    Reston, Virginia, United States Commonwealth of Virginia Full time

    Department: Schar School of Policy and Government Classification: 9-month Instructional Faculty Job Category: Instructional Faculty Job Type: Full-Time Work Schedule: Full-time (1.0 FTE, 40 hrs/wk) Location: Fairfax, VA Workplace Type: On Site Required Salary: Salary commensurate with education and experience Criminal Background Check: ...