--- title: 'Clinical Operations Manager at Tessera Therapeutics' canonical: 'https://feeny.ai/job/clinical-operations-manager-tessera-therapeutics-somerville-massachusetts-a8aykvrnedy2' type: 'job' last_seen: '2026-09-14' --- # Clinical Operations Manager at Tessera Therapeutics - **Company:** Tessera Therapeutics - **Location:** Somerville Massachusetts, United States - **Posted:** 2026-07-23 - **Last confirmed live:** 2026-09-14 - **Apply:** https://job-boards.greenhouse.io/tesseratherapeutics/jobs/5194541007 ## Job description ## Your experience includes… - Bachelor’s degree in a relevant scientific or healthcare discipline, with 8+ years of clinical operations experience, including 4+ years as a clinical trial manager, leading cross-functional teams and accountable for planning and executing global clinical trials. - Experience in managing global clinical operations for first-in-human to Phase 3 Programs from start-up to close out, including managing clinical CRO and other vendors, budgets and timelines - In depth knowledge of ICH/GCP guidelines and working knowledge of regulatory guidelines/directives. - Proficiency in trial management systems, IVRS/IWRS, eTMF, EDC, SmartSheets and Microsoft applications including Project, PowerPoint, Word and Excel - FDA and other regulatory inspection experience is a plus - Current rare disease experience and/or gene therapy experience is highly preferred - Effective project management skills, cross-functional team leadership and organizational skills - Ability to thrive in a fast-paced environment with a demonstrated ability to prioritize and manage multiple competing tasks, and flexibility to adapt to changing program needs You are interested in… - Actively engage in day-to-day clinical trial management activities and lead the cross-functional study team - Contribute to the development and presentation of clinical trial operational strategy and updates to leadership - Provide input into baseline budget development and management, timeline development and management - Identify outsourcing needs of the study and lead the team in the evaluation, selection and management of global Contract Research Organizations (CROs) and other vendors - Review, contribute to and/or author study Protocol, Informed Consent Forms, Investigator Brochures, Clinical Study Reports and Regulatory submission documents - Conduct on-going trial risk identification and analysis, and develop risk-based mitigation strategies in order to maintain study deliverables - Oversee, manage and ensure clinical trial(s) are executed in compliance with key metrics, timelines, budget, operational and quality standards (ICH/GCP/SOPs) - Oversee and ensure the CROs and Third Party Vendors are performing in alignment with study plans and are delivering per the scope of work - Lead the feasibility assessment to select relevant regions and countries for the study. - Oversee and/or conduct site evaluation and selection, and liaise with clinical site staff and Investigators as appropriate to ensure optimal sponsor-site relationships - Lead the development of and oversee implementation of patient recruitment and retention strategies and act on any deviations from plan - Oversee and provide input to the development of study specific documents, including site training materials, case report forms (CRF), statistical analysis plan, and other study plans and manuals - Lead and/or participate in regular review of clinical trial data and metrics, including protocol deviations, to ensure timely identification and closure of data quality issues and non-compliance by sites - Develop, monitor and manage budget for clinical trial(s) including proposals, contracts, and scope changes for study vendors - Provide input to the study drug and clinical supplies forecasting and oversee drug accountability and drug reconciliation - Escalate issues related to study conduct, quality, timelines or budget to line management and other stakeholders and develop and implement appropriate actions to address issues - Ensure inspection readiness through the study lifecycle and support internal audits and external inspection activities and contribute to CAPAs as required - Oversee set-up and maintenance of study systems and documents by CRO, including Trial Master File (TMF) - Manage and oversee study close-out activities including but not limited to database lock, reconciliation of vendor contracts, budget, TMF, and study drug accountability - Ensure compliance with the clinical trial registry requirements About you: You are an individual with excellent team management abilities, who will lead the cross-functional Clinical Study Team and be responsible for overall clinical study delivery. You will be the primary point of contact for leadership and oversight of the assigned study(ies). You have previously demonstrated ability to partner with and proactively manage internal stakeholders, CROs, and vendors, and collaborate cross-functionally to deliver global clinical trials according to the planned timelines and budget, while ensuring quality in accordance with ICH-GCP guidelines and regulatory requirements. Tessera employees are creative and collaborative problem solvers. They have a strong sense of integrity and unwavering commitment to scientific excellence. Meet your Manager: All inquiries regarding the posted position should be directed to the Talent Partner (see below). Interested individuals must apply directly to be considered for the opening. [Navreet Dhindsa, Senior Vice President Clinical Operations](https://www.linkedin.com/in/navreet-dhindsa-376b7311/) Navreet is a Dentist by training and has over 23 years of drug development experience in the Pharmaceutical and Biotechnology industry.  She has successfully held progressive Clinical Operations leadership roles within diverse settings, including big Pharma, we well as mid-size to early-stage Biotech organizations.  Most recently, Navreet was Head of Global Clinical Operations at Apellis Pharmaceuticals, where she provided strategic leadership and oversight of Clinical Operations, Business Optimization and TMF functions. [Meet our Leadership Team and Board of Directors](https://www.tesseratherapeutics.com/leadership) Meet your Talent Partner: [Ben Hoogheem – Senior Director, Head of Talent Management](https://www.linkedin.com/in/labcoat2sportcoat/) As Head of Talent Management at Tessera Therapeutics, Ben leads Tessera’s talent strategy across talent acquisition, performance management, and talent mobility. Ben began his career as an in vivo Pharmacologist, which gave him a lasting appreciation for the rigor, creativity, and collaboration that drive scientific discovery. That foundation continues to shape how he helps build organizations designed to enable science thrive. Ben is focused on aligning exceptional people with bold science – creating the structure, clarity, and culture that empower teams to scale effectively and achieve meaningful impact. Compensation: The stated base salary range represents Tessera’s good-faith estimate for this role. Actual compensation will be determined based on a number of factors, including but not limited to individual qualifications, years of relevant experience, internal compensation alignment, and external market data. Tessera offers a competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness, and financial security of our employees and their families. Benefits currently include group medical, vision, and dental coverage; group life and disability insurance; a 401(k) plan with company contribution; tuition reimbursement; and more. This position is also eligible for an annual incentive bonus and equity grants as part of Tessera’s total rewards program. Per Year Salary Range: $164,000 - $199,000 USD Company Summary: Tessera Therapeutics is pioneering Gene Writing™— a new biotechnology designed to offer scientists and clinicians the ability to write small and large therapeutic messages into the genome, thereby curing diseases at their source. Gene Writing holds the potential to become a new category in genetic medicine, building upon recent breakthroughs in gene therapy and gene editing while eliminating important limitations in their reach, utilization, and efficacy. More about Tessera Therapeutics: Tessera is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, marital status, genetics, protected veteran status, citizenship status, sexual orientation, gender identity or expression, or any other characteristic identified by federal, state, or local laws where we operate. Tessera provides reasonable accommodations to qualified applicants and employees with disabilities. To begin an interactive dialogue with Tessera regarding a reasonable accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied, please contact the recruiter or Accommodations@tesseratx.com Recruitment & Staffing Agencies:  Tessera Therapeutics does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Tessera Therapeutics or its employees is strictly prohibited unless contacted directly by Tessera Therapeutics’ internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Tessera Therapeutics, and Tessera Therapeutics will not owe any referral or other fees with respect thereto. ## About Tessera Therapeutics ## Company Overview - **One-liner**: Tessera Therapeutics is a biotechnology company pioneering Gene Writing™, a novel genome engineering approach designed to write therapeutic messages into the genome to cure diseases at their source. - **Entity Type**: Private (Series B; total funding raised: $773.1M) - **Headquarters**: Somerville, Massachusetts, United States - **Founded**: 2020 (incorporated within Flagship Pioneering) - **Founders**: Spun out of Flagship Pioneering; founding team includes Noubar Afeyan, Geoffrey von Maltzahn, and others associated with Flagship. ## Core Business - Primary industry/industries: Biotechnology Research, Genetic Medicine - Target customers: B2B (pharma/biotech partners like Regeneron) and B2G (grants from ARPA-H, Gates Foundation); enterprise focus on developing therapeutic candidates for monogenic diseases, cancer, autoimmune diseases, and infectious diseases (e.g., HIV). - Mission or purpose statement: “To cure disease by writing in the code of life.” ## Products & Services - **[Gene Writing™ Platform]**: A proprietary technology designed to make small and large permanent alterations to the human genome using engineered gene writers derived from mobile genetic elements. - **[Non-viral LNP Delivery Platform]**: A tissue-targeted lipid nanoparticle (LNP) delivery system designed to deliver gene writers to specific tissues (e.g., liver, T cells, hematopoietic stem cells) for in vivo applications. - **[TSRA-196 (Lead Program)]**: An in vivo gene editing investigational therapy for Alpha-1 Antitrypsin Deficiency (AATD) that has received both FDA Fast Track Designation and Orphan Drug Designation. - **[Pipeline Programs]**: Preclinical programs in sickle cell disease, in vivo CAR-T applications for oncology/autoimmune diseases, and HIV cure approaches (funded by a Gates Foundation/ARPA-H grant). ## Market Standing - **Valuation/Market Cap**: Not publicly disclosed (private company) - **Key Metric**: Total Funding of $773.1M raised across 8 rounds; latest grant (2025-11-08): $41.3M from ARPA-H; latest corporate round (2025-12-01): $150M led by Regeneron. - **Notable Investors/Partners**: Flagship Pioneering (founder), SoftBank Vision Fund, Alaska Permanent Fund, Regeneron (strategic partner), Bill & Melinda Gates Foundation, ARPA-H. - **Growth Signals**: - Received FDA Fast Track and Orphan Drug Designation for TSRA-196 (first in vivo gene editing program for AATD to reach this milestone). - Entered into a major collaboration with Regeneron (2025) to develop gene writing therapies. - Expanding into new disease areas (HIV cure, autoimmune, oncology). - Preclinical data presented at ASGCT (April/May 2026) for sickle cell disease and in vivo CAR-T. ## Competitive Advantages - **Proprietary Gene Writing Technology**: A distinct approach to genome engineering that can make both small and large alterations, including writing new genetic sequences into the genome—differentiating it from gene editing (e.g., CRISPR) which only cuts or corrects. - **Endogenous LNP Delivery**: Early mover in non-viral, tissue-targeted delivery for in vivo genetic medicine, reducing the need for viral vectors. - **Flagship Pioneering Ecosystem**: Deep connection to Flagship provides access to capital, talent, and innovative R&D infrastructure. - **Strong IP Moat**: Extensive patent portfolio around Gene Writers and delivery systems. ## Strategic Focus - **Current Priorities**: - Advancing TSRA-196 toward clinical trials (IND clearance recently achieved). - Developing next-generation Gene Writers with improved efficiency and specificity. - Expanding in vivo delivery capabilities to target T cells (for CAR-T oncology/autoimmune) and hematopoietic stem cells (for sickle cell). - Pursuing HIV cure via a grant-supported program. - **Direction for Growth**: Transition from platform discovery company to a clinical-stage therapeutic developer, building an internal pipeline while partnering strategically (e.g., Regeneron). ## Why Work Here - **Culture Highlights**: Values are explicitly defined: Collaborative, Rigorous, Agile, Tenacious, Community. Described as an inclusive, purpose-driven culture of change makers. - **Remote/Hybrid/Office Policy**: Office-based in Somerville, MA (no fully remote positions currently posted); free onsite gym, bike storage, commuter stipend, and free snack bars. - **Notable Perks**: - Unlimited PTO, 12 paid holidays, 7 “gift of time” days off (including company-wide winter and summer breaks). - Generous medical/dental/vision plans (employer contributions), 401k employer match, company-paid life and disability. - Wellness discounts (gym memberships, equipment, athletic gear), Employee Assistance Program. - Employee Resource Groups (ERGs), volunteerism program, open office hours with CEO/CHRO/R&D Leadership. - **Engineering/Lab Culture**: Heavy R&D focus—49% of employees are in Research; emphasis on cutting-edge genomics, delivery science, and early therapeutic development. - **Talent Signals**: Recent departures and staffing reductions (-39.8% YoY headcount to 210) suggest a strategic pivot/refocus; current active job postings (4 contracts) indicate cautious hiring aligned with pipeline milestones. - **Ideal Candidate**: Passionate about genetic medicine, comfortable with high-science/high-risk early-stage biotech, thrives in a collaborative and rigorous wet-lab environment. ## Sources 1. [Tessera Therapeutics Official Website](https://www.tesseratherapeutics.com/) 2. [Tessera Therapeutics Careers Page](https://www.tesseratherapeutics.com/careers) 3. [Tessera Therapeutics Leadership Page](https://www.tesseratherapeutics.com/leadership) 4. [Tessera Therapeutics Focus Areas](https://www.tesseratherapeutics.com/focus-areas) 5. 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