Associate Director or Director, Clinical Operations
About The Position
Kymera is a clinical-stage biotechnology company pioneering the field of targeted protein degradation (TPD) to develop medicines that address critical health problems and have the potential to dramatically improve patients’ lives. Kymera is deploying TPD to address disease targets and pathways inaccessible with conventional therapeutics. Having advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. Founded in 16, Kymera has been recognized as one of Boston’s top workplaces for the past several years. For more information about our science, pipeline and people, please visit www.kymeratx.com or follow us on X (formerly Twitter) or LinkedIn.
Requirements
- BS degree and 8+ years of experience in clinical operations in biotech/pharma.
- 5 years’ experience leading global clinical trials
- Inspection readiness experience preferred
- Experience working on large, global, complex phase 2b/3 or late stage trials.
- Respiratory or Immunology experience highly preferred.
- Broad knowledge of Global regulations and guidelines including CFR, ICH GCP, HIPAA, GDPR, and the Protection of Human Research Subjects.
- Strong project management skills with the ability to manage multiple trials simultaneously.
- Excellent problem-solving, leadership, and communication skills.
- Ability to work in a fast-paced, dynamic environment with cross-functional teams.
Responsibilities
- Contribute to the planning, implementation, and execution of global clinical trials.
- Plan, execute, and lead study-specific meetings (e.g., internal core team meetings, investigator meetings, etc), as needed.
- Provide input for the design of the Informed Consent Form(s), eCRFs, monitoring conventions, edit checks, etc.
- Provide study-specific training and leadership to clinical research staff, CRO, CRAs, sites and other contract personnel.
- Manage study timelines and metrics to ensure completion of study deliverables.
- Lead site feasibility and selection qualification, initiation, and oversight of outsourced monitoring activities.
- Review monitoring reports to ensure quality and resolution of site-related issues.
- Ensure timely enrollment and data collection at clinical trial sites.
- Collaborate with the data management team to ensure data integrity and timely database lock.
- Ensure tracking, review of protocol deviations, and assess impact on study data.
- Work closely with translational medicine team to ensure appropriate incorporation of bioanalytical sampling plan into clinical protocols and relevant data output of the trial is provided to functional groups for review.
- Partner with Operational Excellence and assigned Site Engagement Leads to help drive site engagement and bolster recruitment
- Serve as key counterpart of Clinical Outsourcing to build RFPs and support the selection of clinical vendors
- Oversee and contribute to Sponsor Oversight activities including but not limited to review of KPIs, KRIs, PDs, risks, Data Review Findings, etc. to assess the health of the study and proactively ensure mitigations are in place to achieve Kymera’s quality standards
- Contribute to clinical operations process improvement initiatives
- Maintain accurate and complete trial documentation.
- Proactively identify and resolve clinical project issues.
Benefits
- annual bonus
- equity participation
- comprehensive benefits
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What This Job Offers
Job Type
Full-time
Career Level
Senior
