Somerville, Massachusetts, United States
Minimum Qualifications:
- MS, MBA, MPH or PhD with 15+ years of industry experience, 10+ years of clinical operations line management experience.
- Overseeing Phase 1-3 global clinical trials, patient registries, and support of regulatory engagements including IND/CTA and NDA/BLA/MAA to meet corporate goals.
- Excellent understanding and demonstrated application of FDA guidelines, Good Clinical Practice (GCP), ICH and applicable Standard Operating Procedures.
- Selecting and managing CROs (and other vendors) to meet or exceed corporate goals.
- Building clinical operations infrastructure including recruiting, managing, mentoring, and training operations team members and drafting SOPs.
You are interested in:
- Leading all operational aspects of clinical studies and patient registries to achieve corporate goals for timelines, budget and quality.
- Selecting and overseeing vendors, including Contract Research Organizations (CROs), laboratory vendors, and other third parties, to ensure they meet timelines, budgets, quality, compliance, and goals.
- Reaching patient recruitment goals by leading the operational strategy for identifying, recruiting, and retaining trial subjects.
- Preparing clinical operations plans, timelines/costs/resources, documents/presentations for internal planning and study execution.
- Leading efforts to identify and build relationships with key investigators and trial sites to ensure successful execution of clinical studies in compliance with GCP/ICH, global regulatory and patient safety requirements.
- Supporting regulatory submissions including timeline planning, data preparation, document generation, inspection readiness, and query responses.
- Representing the company as a senior clinical operations spokesperson before appropriate scientific, medical, regulatory, and business associates.
About you:
You are a dynamic clinical operations leader who has experience providing strategic hands-on oversight of global clinical studies to support a growing pipeline of novel genetic medicines. You have experience leading a team of internal and external clinical operations professionals to meet aggressive timelines, manage budgets, and select/oversee vendors. You are interested in supporting the planning, execution, oversight, monitoring, auditing, and reporting of all phases of clinical trials.
At Tessera, you will find a highly collaborative, matrixed environment defined by rapid scientific innovation and a mission-driven culture dedicated to transforming the lives of patients with devastating genetic diseases. You will make our mission possible by implementing state-of-the-art approaches to achieve operational excellence, optimize clinical trial efficiency, and accelerate the development of our gene therapies.
Tessera leaders are empathetic and transparent coaches with a strong sense of integrity. They are committed to the growth and development of their teams, the organization, and themselves.
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 first-in-category companies to transform human health and sustainability.
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.
Equal Opportunity Employment:
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.
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.
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