Director, Study Start-Up

Kymera Therapeutics•Watertown, MA

1d•$195,000 - $275,000

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 2016, Kymera has been recognized as one of Boston’s top workplaces for the past several years.

Requirements

10+ years of experience in the biotech/pharmaceutical industry with direct experience in project management within Clinical Operations
Proven track record in process improvement, clinical trial execution, and operational strategy.
Experience with planning, management, and oversight of activities and deliverables within Clinical Operations
Strong understanding of clinical trial management, ICH-GCP, and regulatory compliance
Proven track record of managing multiple projects and/or programs concurrently
Excellent analytical, problem-solving, and organizational skills.
Strong communication and interpersonal skills with the ability to influence cross-functional stakeholders.
Demonstrated ability to lead change and foster a culture of continuous improvement.

Responsibilities

Provide strategic and operational leadership for end‑to‑end study start‑up activities across assigned clinical programs, ensuring timely, compliant, and high‑quality site activation.
Accountable for development, execution, and ongoing optimization of study‑specific start‑up strategies, including country selection, regulatory and ethics submissions, site feasibility and selection, contract and budget execution, and site activation readiness.
Establish and maintain clear start‑up timelines, metrics, and dashboards; proactively identify risks to activation timelines and drive mitigation plans to achieve first‑patient‑in (FPI) and enrollment targets.
Provide oversight of country‑ and site‑level regulatory and ethics submissions (e.g., IRB/EC/HA), ensuring consistency with global strategy and local regulatory requirements.
Ensure quality, completeness, and inspection readiness of start‑up documentation, including Trial Master File (TMF) content and country‑level start‑up records, in accordance with GCP and internal SOPs.
Partner with Clinical Research Organization(s) to oversee site contract and budget negotiations, ensuring alignment with approved study budgets and timely execution to support activation timelines.
Serve as the primary escalation point for complex start‑up challenges, including site readiness or performance risks, regulatory delays or vendor issues; communicate status and resolution plans to senior leadership.
Contribute to portfolio‑level planning by providing start‑up insights and recommendations to inform study design, country strategy, resourcing, and feasibility assumptions.
Develop and maintain study start‑up processes, systems, and tools to reduce cycle times, improve quality, and enhance predictability of start‑up delivery.
Ensure start‑up activities are conducted in compliance with global regulations, internal policies, and company quality standards, maintaining a strong focus on patient safety and data integrity.
Support organizational readiness for audits and inspections related to study start‑up activities, partnering with Quality Assurance as needed.