Clinical Operations Lead

Your experience includes

• Bachelors degree in a relevant scientific or healthcare discipline with 8 years of clinical operations experience including 4 years as a clinical trial manager leading crossfunctional teams and accountable for planning and executing global clinical trials.
• Experience in managing global clinical operations for firstinhuman to Phase 3 Programs from startup 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 crossfunctional team leadership and organizational skills
• Ability to thrive in a fastpaced 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 daytoday clinical trial management activities and lead the crossfunctional 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 ongoing trial risk identification and analysis and develop riskbased 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 sponsorsite 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 noncompliance 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 setup and maintenance of study systems and documents by CRO including Trial Master File (TMF)
• Manage and oversee study closeout 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 crossfunctional 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 crossfunctionally to deliver global clinical trials according to the planned timelines and budget while ensuring quality in accordance with ICHGCP 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

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 midsize to earlystage 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:

NarissaFurtadoCordeiroManager Talent Acquisition

Narissa joined the Biotechnology industry shortly after graduating with her BS in Marketing from Franklin Pierce University. She is currently pursuing an MS in Legal Studies from Northeastern University School of Law while working full time as a Manager in Talent Acquisition at Tessera. She is passionate about helping individuals find a fulfilling opportunity while considering their interests aspirations and technical skills. Narissa lives in Northern Vermont and enjoys spending time outdoors with her husband threeyearold daughter and German Shepherd.

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 401(k) with company contribution tuition reimbursement and much more.

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. Tessera Therapeutics was founded by Flagship Pioneering a life sciences innovation enterprise that conceives resources and develops firstincategory companies to transform human health and sustainability.

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

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.