Clinical Operations Manager

Clinical Operations Manager

Somerville, Massachusetts, United States

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:

Navreet Dhindsa, Senior Vice President Clinical Operations

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, 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

Meet your Talent Partner:

Ben Hoogheem – Senior Director, Head of Talent Management

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 View email address on click.appcast.io

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.