Associate Director, Clinical Operations (Clinical Records Management & SOP)

About Generate:BiomedicinesGenerate:Biomedicines is a new kind of therapeutics company – existing at the intersection of machine learning, biological engineering, and medicine – pioneering Generative Biology™ to create breakthrough medicines where novel therapeutics are computationally generated, instead of being discovered. The Company has built a machine learning-powered biomedicines platform with the potential to generate new drugs across a wide range of biologic modalities. This platform represents a potentially fundamental shift in what is possible in the field of biotherapeutic development.We pursue this audacious vision because we believe in the unique and revolutionary power of generative biology to radically transform the lives of billions, with an outsized opportunity for patients in need. We are seeking collaborative, relentless problem solvers that share our passion for impact to join us!Generate:Biomedicines was founded in 2018 by Flagship Pioneering and has received nearly $700 millionin funding, providing the resources to rapidly scale the organization. The Company has offices in Somerville and Andover, Massachusetts with 300+ employees.The Role: Generate:Biomedicines is seeking an Associate Director, Clinical Operations to lead the planning, oversight, and execution of early- to late-stage clinical trials. This role may serve as the operational lead on high-priority studies and provide cross-functional leadership in collaboration with Clinical Development, Regulatory Affairs, Biometrics, and other key functions. Reporting to a Director or Senior Director or VP of Clinical Operations, this individual will ensure trial delivery on time, within budget, and in accordance with regulatory and GCP standards. The Associate Director will also mentor and guide junior clinical operations team members.Here's how you'll contribute:Lead end-to-end execution of clinical studies, including vendor oversight, budget and timeline management, and quality assuranceAct as the primary operational point of contact for assigned studies, ensuring cross-functional alignment and executionOversee CRO selection, contract negotiation, and performance management; lead bid defense and vendor governance meetingsDrive site identification, qualification, initiation, and ongoing engagement activities in partnership with CRO and clinical sitesReview and contribute to protocol development, CRFs, study manuals, ICFs, and other key study documentsEnsure high-quality data collection and timely resolution of study issues including safety, protocol deviations, and complianceMaintain inspection-ready Trial Master Files and oversee document quality and completenessDevelop operational plans, risk mitigation strategies, and study status reports for internal and external stakeholdersContribute to department-level initiatives including SOP development and process optimizationLeadership ResponsibilitiesSet clear expectations for study team performance and foster a high-performing, inclusive cultureCoach and mentor junior CTMs and Clinical Associates, promoting growth and developmentCommunicate with empathy, clarity, and courage across cross-functional teamsChampion collaboration and shared accountability across departmentsThe Ideal Candidate will have:Bachelor’s degree in a scientific or healthcare-related field; advanced degree preferred8+ years of experience in clinical trial operations, including 3+ years of independent study managementProven ability to lead global clinical studies and manage CROs, labs, and vendorsThorough understanding of GCP/ICH guidelines and global regulatory requirementsStrong project management, problem-solving, and negotiation skillsExcellent communication and collaboration abilities across diverse stakeholder groupsPrior experience mentoring, managing or directly supervising clinical operations talentEducationBachelor’s degree required; life sciences or related field preferredNice to Have (Optional)Experience in respiratory, immunology, or rare disease trialsFamiliarity with IND submissions and global study executionKnowledge of clinical systems (e.g., EDC, eTMF, CTMS)Why Join UsJoin a mission-driven company revolutionizing medicine with Generative Biology™. This is an opportunity to lead impactful clinical programs and shape how we deliver innovative therapies to patients.Equal Opportunity Employer StatementGenerate:Biomedicines is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, or Veteran status.Recruitment & Staffing Agencies: Generate:Biomedicines does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Generate:Biomedicines or its employees is strictly prohibited unless contacted directly by the Company’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Generate:Biomedicines and the Company will not owe any referral or other fees with respect thereto.Compensation: The base salary range provided reflects our current estimate of what we anticipate paying for this position. Your actual base salary will be based on several factors, including job-related skills, experience, internal equity, relevant education or training, and market dynamics. In addition, you will be eligible for an annual bonus, equity compensation, and a competitive benefits package.Per Year Salary Range$160,000—$224,000 USDOriginally posted on Himalayas

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