- Job Type: Full-Time
- Function: Clinical Research
- Industry: Therapeutics
- Post Date: 08/01/2022
- Website: talaristx.com
- Company Address: 570 S. Preston St, Suite 400, Louisville, KY, 40202
About Talaris TherapeuticsTalaris Therapeutics, Inc. is a late-clinical stage cell therapy company developing therapies with the potential to transform the standard of care in solid organ transplantation and severe immune and blood disorders.
The VP of Clinical Operations, reporting to the chief medical officer (CMO), will be responsible for developing and implementing strategies to successfully execute and enhance Talaris’ current and future clinical programs. This role will provide effective leadership, and oversight of clinical studies. This individual will be responsible for ensuring that our clinical stage projects achieve program our objectives within established budget and timelines and will provide direction and management oversight to Talaris' team of clinical operations directors, as well as our external CRO(s) and vendors.
Duties and Responsibilities:
- Provide operational expertise and strategic input to the advancement of clinical development plans
- Lead operational resource allocation, prioritization and budgeting discussions and decisions to ensure department goals and milestones are aligned and tracking to corporate objectives
- Manage clinical operations team members and external vendors relating to the Clinical Operations function, and provide management and guidance across the function
- Manage our partnership with our current CRO and other vendor clinical operations resources for the efficient execution of our current clinical program and proactive identification and rapid resolution of any performance issues, acting as a point of contact for escalation management
- Manage progress of clinical studies and ensure adherence to the protocol, timelines, and budget. This includes reviewing site recruitment, initiation and patient enrollment progress and acting on trending reports.
- Develop, maintain, and report on program budgets, including forecasting in support of financial goals
- Prepare and present key study updates/status reports to senior management and other key stakeholders
- Ensure that external vendors are selected and proactively managed to deliver within agreed timelines and budget
- Direct the clinical operations aspects of cross functional work processes involving medical writing, legal, finance, quality assurance, pharmacovigilance, biometrics, program management, regulatory, pharmaceutical sciences, IT, medical affairs, translational science and clinical science
- Work collaboratively in a cross functional team environment with functional leaders within Talaris responsible for Program Management, CMC, Nonclinical, Regulatory Affairs, and Legal/Finance
- Provide input on strategy in the development of realistic project milestones and deliverables
- Develop and manage integrated study timelines and lead study operational meetings to review trial status/progress
- Develop clinical operations strategy including risk management and contingency planning
- Ensure all clinical trials are executed per key metrics (timelines, budget, operational and quality standards [ICH/GCP/SOPs])
- Support the CMO in the development and implementation of clinical QA plans and procedures
- Contribute expertise to, and assist with review of, to global regulatory submissions (FDA, EMA, Health Canada and other governing regulatory bodies)
- Drive creation of clinical operations standards, systems, and processes across the clinical stage program
- Apply appropriate project management tools and processes
- Maintain procedures to verify the accuracy and timeliness of trial information in all trial databases and tracking systems
- Foster a highly collaborative and communicative culture and serve as a leadership role model within the company and with external stakeholders
- Performs other duties as assigned.
Minimum Education, Training, and Experience Required:
- Bachelor’s Degree in Life Sciences discipline (or equivalent)
- 12+ years of clinical operations experience in a pharmaceutical, biotech and/or contract research organization (CRO) setting; including management of a CRO
- Experience managing later-stage clinical trials involving solid organ transplant, stem cells, CAR-T and/or other autologous or allogeneic personalized cell or gene therapies is a significant plus
- 8+ years supervisory experience, 5+ years direct project/trial management experience and 4+ years in leadership role
- In-depth, working knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
- Strong leadership, collaborative, communication and interpersonal skills, and ability to effectively manage a clinical operations team that is mostly working remotely.
- Proven ability to build strong relationships with CROs/vendors
- Excellent computer skills (Microsoft Office Suite, Project, Visio, Electronic Data Capture and Trial Master File Systems)
- Global Clinical Trial Experience and the ability to support more than one clinical trial is preferred
- Experience working independently and in a team environment, being flexible and adapting in a changing environment
- Location flexible, but MA or NY/NJ/PA or S. Ohio/KY area is preferred
- Ability to travel up to 25%
- Sitting/using a computer for 8 hours/day
- Competitive compensation including bonus opportunity and equity participation
- Medical / Dental / Vision Insurance
- Company Paid Long & Short Term Disability
- 25 Days Paid Time Off + 10 Paid Company Holiday’s
- 401k with Employer Contribution
- Stock Options and Restricted Stock Units (RSUs)
- Paid Parental and Organ Donor Leave
- Employee Stock Purchase Plan (ESPP)
- Generous Professional Development Policy for Job-Related External Learning Opportunities
- Employee Assistance Program (EAP)
Talaris Therapeutics requires that all employees be fully vaccinated for COVID-19. Proof of vaccination or sincerely held religious belief and/or medical exemption is required upon hire. Talaris Therapeutics will engage in an interactive dialogue process with employees who have documented medical conditions and/or sincerely held religious beliefs that would prevent them from getting vaccinated, in accordance with all applicable laws.
Talaris Therapeutics, Inc. (“Talaris”) is a late-clinical stage, publicly traded (Nasdaq Global Market: TALS), biotechnology company that is developing an innovative method of allogenic hematopoietic stem cell transplantation that we believe has the potential to transform the standard of care in sold organ transplantation, certain severe autoimmune diseases, and certain severe non-malignant immune and metabolic disorders. In a ground-breaking, phase 2 study, our lead therapy, FCR001, enabled 70% of living donor kidney transplant recipients to be weaned off all immunosuppression within 12 months of their kidney transplant without rejecting their donated organ.
We are currently conducting FREEDOM-1, a randomized, controlled, open-label Phase 3 registration trial in the United States of FCR001 in 120 adult living donor kidney transplant (LDKT) recipients, as well as two additional Phase 2 clinical trials: FREEDOM-2, in which we are evaluating the potential of FCR001 to induce durable immune tolerance in patients who have previously received a kidney from a living donor, and FREEDOM-3 in which we are evaluating the safety and efficacy of FCR001 in adults with a severe form of scleroderma, a debilitating autoimmune disease. We currently have approximately 120 employees. We maintain corporate offices in Boston, MA in addition to our cell processing facility in Louisville, KY and our process and analytical development labs in Houston, TX.
Equal Employment Opportunity: Talaris Therapeutics is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status. Reasonable accommodation will be provided for qualified individuals with disabilities and for qualified disabled veterans in job application procedures, as required by applicable law. If you have any difficulty using our online application system and need an accommodation due to a disability, you may contact Talent Acquisition by emailing us at firstname.lastname@example.org. When emailing, please include a description of your requested accommodation, your name and contact information.
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