BioSpace
Associate Director – Clinical Operations
BioSpace is at the forefront of clinical operations at Verve Therapeutics, a subsidiary of Eli Lilly & Company. We seek an experienced leader to drive and oversee all aspects of clinical studies for our genetic medicines program.
Organization Overview Verve Therapeutics is a clinical‑stage genetic medicines company focusing on cardiovascular disease. With programs VERVE‑101, VERVE‑102, and VERVE‑201 targeting LDL‑C lowering genes, we are pioneering single‑course gene‑editing therapies. Based in Boston, Massachusetts, Verve is a top workplace and operates under the umbrella of Lilly Research Labs.
Responsibilities
Drive and oversee all aspects of clinical studies from planning to close‑out, ensuring adherence to timelines, budgets, and regulatory guidelines (FDA, EMA, GCP, ICH) using a risk‑based approach.
Develop and implement operational plans for clinical studies, managing CROs and vendors to ensure high‑quality execution.
Lead internal clinical trial team meetings, tracking key study metrics (e.g., enrollment, site feasibility, and data collection) to ensure progress and alignment with company goals.
Partner with cross‑functional teams (e.g., Clinical, Regulatory, Supply Chain) to support the strategic development and execution of clinical programs.
Partner with cross‑functional team and CRO to ensure patient recruitment and retention strategies are carried out effectively to facilitate on‑time study enrollment.
Ensure efficient database lock by overseeing monitoring plans and taking part in data review and reconciliation efforts.
Contribute to the development and review of key regulatory documents (e.g., Protocol, Investigator Brochure, Clinical Study Report, Informed Consent Forms, patient‑facing materials, and vendor plans).
Assist in maintaining a quality‑focused clinical infrastructure by developing, revising, and implementing SOPs to ensure operational consistency with GXP standards across trials and programs.
Engage in the planning of quality assurance activities and coordinate remediation of audit findings.
Lead vendor selection, contract/budget negotiation, and management (including RFP generation, review of SOWs, and Change Orders), serving as a point of escalation as needed.
Develop and maintain project budget forecasts, ensuring efficient resource allocation, cost‑effective execution, and punctual review of invoices.
Provide ongoing oversight, maintenance and evaluate completeness of the Trial Master File (TMF) by performing periodic QC reviews to ensure the TMF is always "inspection ready".
Lead, mentor, and develop a high‑performing team by fostering collaboration, resolving challenges, and ensuring peak performance. Provide training and guidance to junior staff to support their growth and expertise in clinical operations.
Set clear objectives, delegate responsibilities, and drive strategic alignment with company priorities.
Cultivate an inclusive and collaborative culture, empowering team members and reinforcing company values.
Tackle complex challenges by integrating diverse perspectives into innovative, actionable strategies.
Make data‑driven decisions, providing insightful recommendations to shape project timelines, goals, and resource allocation.
Build strong relationships with senior management and external partners, influencing key project outcomes and ensuring strategic alignment.
Partner with internal teams and external partners to ensure seamless execution of clinical studies. Foster strong relationships across departments to align objectives, streamline workflows, and drive strategic decision‑making.
Basic Qualifications / Requirements
Bachelor’s degree in a life science, allied health field, or other relevant field (e.g., nursing, medical or laboratory technology).
At least 9 years of relevant experience in clinical operations.
Additional Skills / Preferences
Proven ability to lead teams, manage projects, and solve complex problems.
Strong communication skills, with the ability to persuade and influence partners in sensitive, high‑impact situations.
High emotional intelligence, with the ability to manage both your own emotions and those of others, fostering a collaborative and positive work environment.
Skilled in conflict resolution and maintaining relationships in challenging scenarios.
Experience managing contracts, budgets, resources, and schedules to meet performance and project requirements.
Strategic thinker with the ability to clarify and structure ambiguous problems.
Experience in policy development and implementation with potential company‑wide effects.
Ability to build and maintain strong team dynamics, proactively preventing and resolving challenges.
Compensation & Benefits Base salary: 127,500 – 187,000 USD (dependent on education, experience, and geographic location). Full‑time employees are eligible for bonuses, 401(k), pension, vacation benefits, medical/dental/vision and prescription drug benefits, flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts), life insurance and death benefits, leave of absence benefits, and well‑being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).
EEO Statement Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance.
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Organization Overview Verve Therapeutics is a clinical‑stage genetic medicines company focusing on cardiovascular disease. With programs VERVE‑101, VERVE‑102, and VERVE‑201 targeting LDL‑C lowering genes, we are pioneering single‑course gene‑editing therapies. Based in Boston, Massachusetts, Verve is a top workplace and operates under the umbrella of Lilly Research Labs.
Responsibilities
Drive and oversee all aspects of clinical studies from planning to close‑out, ensuring adherence to timelines, budgets, and regulatory guidelines (FDA, EMA, GCP, ICH) using a risk‑based approach.
Develop and implement operational plans for clinical studies, managing CROs and vendors to ensure high‑quality execution.
Lead internal clinical trial team meetings, tracking key study metrics (e.g., enrollment, site feasibility, and data collection) to ensure progress and alignment with company goals.
Partner with cross‑functional teams (e.g., Clinical, Regulatory, Supply Chain) to support the strategic development and execution of clinical programs.
Partner with cross‑functional team and CRO to ensure patient recruitment and retention strategies are carried out effectively to facilitate on‑time study enrollment.
Ensure efficient database lock by overseeing monitoring plans and taking part in data review and reconciliation efforts.
Contribute to the development and review of key regulatory documents (e.g., Protocol, Investigator Brochure, Clinical Study Report, Informed Consent Forms, patient‑facing materials, and vendor plans).
Assist in maintaining a quality‑focused clinical infrastructure by developing, revising, and implementing SOPs to ensure operational consistency with GXP standards across trials and programs.
Engage in the planning of quality assurance activities and coordinate remediation of audit findings.
Lead vendor selection, contract/budget negotiation, and management (including RFP generation, review of SOWs, and Change Orders), serving as a point of escalation as needed.
Develop and maintain project budget forecasts, ensuring efficient resource allocation, cost‑effective execution, and punctual review of invoices.
Provide ongoing oversight, maintenance and evaluate completeness of the Trial Master File (TMF) by performing periodic QC reviews to ensure the TMF is always "inspection ready".
Lead, mentor, and develop a high‑performing team by fostering collaboration, resolving challenges, and ensuring peak performance. Provide training and guidance to junior staff to support their growth and expertise in clinical operations.
Set clear objectives, delegate responsibilities, and drive strategic alignment with company priorities.
Cultivate an inclusive and collaborative culture, empowering team members and reinforcing company values.
Tackle complex challenges by integrating diverse perspectives into innovative, actionable strategies.
Make data‑driven decisions, providing insightful recommendations to shape project timelines, goals, and resource allocation.
Build strong relationships with senior management and external partners, influencing key project outcomes and ensuring strategic alignment.
Partner with internal teams and external partners to ensure seamless execution of clinical studies. Foster strong relationships across departments to align objectives, streamline workflows, and drive strategic decision‑making.
Basic Qualifications / Requirements
Bachelor’s degree in a life science, allied health field, or other relevant field (e.g., nursing, medical or laboratory technology).
At least 9 years of relevant experience in clinical operations.
Additional Skills / Preferences
Proven ability to lead teams, manage projects, and solve complex problems.
Strong communication skills, with the ability to persuade and influence partners in sensitive, high‑impact situations.
High emotional intelligence, with the ability to manage both your own emotions and those of others, fostering a collaborative and positive work environment.
Skilled in conflict resolution and maintaining relationships in challenging scenarios.
Experience managing contracts, budgets, resources, and schedules to meet performance and project requirements.
Strategic thinker with the ability to clarify and structure ambiguous problems.
Experience in policy development and implementation with potential company‑wide effects.
Ability to build and maintain strong team dynamics, proactively preventing and resolving challenges.
Compensation & Benefits Base salary: 127,500 – 187,000 USD (dependent on education, experience, and geographic location). Full‑time employees are eligible for bonuses, 401(k), pension, vacation benefits, medical/dental/vision and prescription drug benefits, flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts), life insurance and death benefits, leave of absence benefits, and well‑being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).
EEO Statement Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance.
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