Director, Study Start-Up

Kymera Therapeutics; Boston (MA); On-site; USD 195,000 - 275,000; Full time

Job summary

Kymera Therapeutics, based in Boston, is seeking a seasoned leader for Clinical Operations to oversee study start-up activities across clinical programs. The role requires over 10 years of experience in the biotech industry, particularly in project management and clinical trial execution. Responsibilities include strategic planning, risk management, and ensuring compliance with regulatory requirements. The position offers a competitive salary between $195,000 and $275,000, along with an annual bonus and comprehensive benefits.

Qualifications

• 10+ years of experience in the biotech/pharmaceutical industry.
• Proven track record in managing multiple projects concurrently.
• Strong understanding of clinical trial management and regulatory compliance.

Responsibilities

• Provide strategic and operational leadership for clinical program start-up activities.
• Ensure quality and inspection readiness of start-up documentation.
• Develop and maintain study start-up processes and systems.

Skills

Experience in project management within Clinical Operations

Process improvement

Clinical trial execution

Strong communication and interpersonal skills

Analytical and problem-solving skills

Job description

Who we are:

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. For more information about our science, pipeline and people, please visit www.kymeratx.com or follow us on X (formerly Twitter) or LinkedIn.

How we work:

• PIONEER: We are courageous, resilient and rigorous in our mission to improve patients’ lives through our revolutionary degrader medicines.
• COLLABORATE: We value trust + transparency from everyone. Our goals are shared, our decisions data-driven and our camaraderie genuine.
• BELONG: We recognize our differences, inviting curiosity and inclusivity, so that our people are valued, seen, and heard.

How you’ll contribute:

• 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.

Skills and experience you’ll bring:

• 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.

Kymera Therapeutics is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, creed, gender, national origin, age, disability, veteran status, pregnancy, sex, marital status, gender expression or identity, genetic information, sexual orientation, citizenship, or any other legally protected class.

Compensation:

• Kymera offers a competitive compensation package that recognizes both results and capabilities through market‑based, performance‑driven pay.
• The anticipated base salary range for this role is $195,000 – $275,000, with eligibility for annual bonus, equity participation, and comprehensive benefits.
• Actual salary is based on a holistic evaluation of the specific role/level as well as each candidate’s depth of experience and the capabilities they bring to the position.