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We are differentiated in the composition of our team, which includes individuals from all areas—science, technology, and business—who share apioneering mindset, and are passionate about finding better ways to create medicines for patients.

We seek diverse perspectives because we believe that engaging in candid, productive conflict around ideas is how we will push the boundaries of the possible. Associate Director, Clinical Operations (Clinical Records Management & SOP) Remote-US About Generate:Biomedicines Generate: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 assurance Act as the primary operational point of contact for assigned studies, ensuring cross-functional alignment and execution Oversee CRO selection, contract negotiation, and performance management; lead bid defense and vendor governance meetings Drive site identification, qualification, initiation, and ongoing engagement activities in partnership with CRO and clinical sites Review and contribute to protocol development, CRFs, study manuals, ICFs, and other key study documents Ensure high-quality data collection and timely resolution of study issues including safety, protocol deviations, and compliance Maintain inspection-ready Trial Master Files and oversee document quality and completeness Develop operational plans, risk mitigation strategies, and study status reports for internal and external stakeholders Contribute to department-level initiatives including SOP development and process optimization Leadership Responsibilities Set clear expectations for study team performance and foster a high-performing, inclusive culture Coach and mentor junior CTMs and Clinical Associates, promoting growth and development Communicate with empathy, clarity, and courage across cross-functional teams Champion collaboration and shared accountability across departments The Ideal Candidate will have: Bachelor’s degree in a scientific or healthcare-related field; advanced degree preferred 8+ years of experience in clinical trial operations, including 3+ years of independent study management Proven ability to lead global clinical studies and manage CROs, labs, and vendors Thorough understanding of GCP/ICH guidelines and global regulatory requirements Strong project management, problem-solving, and negotiation skills Excellent communication and collaboration abilities across diverse stakeholder groups Prior experience mentoring, managing or directly supervising clinical operations talent Education Bachelor’s degree required; life sciences or related field preferred Nice to Have (Optional) Experience in respiratory, immunology, or rare disease trials Familiarity with IND submissions and global study execution Knowledge of clinical systems (e.g., EDC, eTMF, CTMS) Why Join Us Join 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 Statement Generate: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. #LI-RT1 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 USD Create a Job Alert Interested in building your career at Generate Biomedicines? Get future opportunities sent straight to your email. Apply for this job * indicates a required field First Name * Last Name * Email * Phone * Resume/CV * Enter manually Accepted file types: pdf, doc, docx, txt, rtf Enter manually Accepted file types: pdf, doc, docx, txt, rtf Education School Select... Degree * Select... Address Line 1 * Street address Address Line 2 * street address continued City * The city in which you reside State * Select... The State within the United States in which you reside Postal Code * What geographical area do you live in? * Select... Are you legally authorized to work in the United States? * Select... Do you now or will you in the future require sponsorship to work in the U.S.? (e.g., H-1B, O-1, OPT, etc)? * Select... If you'll require the company to commence ("sponsor") an immigration or work permit case in order to employ you, either now or at some point in the future, then you should select Yes. Otherwise, select No. Are you able to work in the specified job location, or are you willing to relocate for this position? * Select... When are you able to start a new position? * Do you have a bachelor’s degree in a life sciences or healthcare-related field? * Select... Do you have at least 8 years of experience in clinical trial operations, including 3 or more years independently managing clinical studies? * Select... Have you led global clinical trials and managed vendors such as CROs, labs, or central services? * Select... Are you well-versed in GCP, ICH guidelines, and global regulatory requirements for clinical trials? * Select... Have you directly mentored or managed junior clinical operations staff, such as CTMs or Clinical Trial Associates? * Select... How did you hear about this job? * Select... If other, please share source LinkedIn Profile Website Demographic Questions At Generate Biomedicines, we value belonging and believe in fostering an environment where a diversity of perspectives can thrive. This core value is a pillar of our business and critical to our success. Your responses will be used (in aggregate only) to help us identifyareas of improvement in our process. Your responses will not be associated with your specific application and will not in any way be used in the hiring decision. Completion of the form is entirely voluntary . How would you describe yourself as male, female, and/or transgender? (Select all that apply) Select... Which of the following best represents how you think of yourself? (Select all that apply) Select... How would you describe your race? (Select all that apply) Select... Are you of Hispanic, Latino, or Spanish origin? Select... Have you served on active duty in the U.S. Armed Forces, Reserves, or National Guard? Select...

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