Assoc Dir, Clinical Trial Services

POSITION SUMMARY

The Associate Director, Clinical Trials Services oversees a group of Clinical Biospecimen Operations Managers working on multiple projects/studies focused on delivery of Natera's testing pipeline for Pharma and Consortium/Academic studies where Natera tests are run as part of an externally sponsored clinical trial or a companion diagnostic program. This role provides direct management to individual contributors to ensure delivery of study objectives. Coordinates with management for department resources. Fields management requests, provides resourcing feedback and delegates work accordingly

PRIMARY RESPONSIBILITIES

• Lead, build, develop and manage an effective team of professionals dedicated to delivery of externally sponsored oncology studies, including Pharma and/or Consortium/Academic studies. 

• Is directly responsible for/leads a team that performs: 

• • Maintain oversight of all study operational activities including leading study requirements efforts to drive readiness timelines, kick-off and planning activities, study conduct management within contractual agreements, and closure activities. Generally, oversees phase III or large consortia studies, but may also support or lead phase I/II pharma or small consortia studies. 

  • Regularly monitors the overall health of the study from study start-up through closure, including routine evaluation of key metrics (TAT, TNP), project management of key milestones and activities, and escalation of project risks and mitigation plans both internally as well as to the study sponsor when appropriate.

• Partner with internal stakeholders from Laboratory Operations, Alliance Management, Product Management, R&D, CLIA Laboratory, Data Management, Business Development, Regulatory Affairs, and Clinical Quality to ensure on-schedule delivery of sample and study management requirements 

• Work with ClinOps leadership to ensure proactive assignment of resources to Pharma and Consortium/Academic 

• Collaborate with ClinOps leadership and cross-functionally at Natera to troubleshoot high complexity technical and non-technical problems across project delivery, ensure standardization of activities where possible, and enable optimal use of human resources across Natera departments 

• Represent the Pharma Operations team at cross-functional internal and external joint project level meetings if issues are escalated 

• Maintain readiness for audits, inspections and monitoring visits 

• Facilitate the personal development of staff, including fostering career growth, and providing relevant company-specific, ethical, and regulatory trainings. Serves as a mentor and guide to junior employees. 

• Manages and leads a team working on a complex set of objectives (e.g. one or more clinical studies or projects) 

• Responsible for staffing of assigned projects and for development of direct reports 

• Manages a team of 2-5 direct reports working on multiple projects or studies

• Makes recommendations to senior management on human resources, project budget, and department operations and process 

• Effectively presents to senior management or external stakeholders on matters of critical importance to Natera 

• Can change the thinking of or gain acceptance from others in sensitive situations without damage to the relationship 

• Seen as an established leader leader 

• Proficient people manager 

• Represents the Clinical Trial Operations department in cross functional interactions 

• Takes OKRs and business goals and determines the path to deliver results from the team 

• Makes decisions within the scope of assigned projects or studies with limited input from more senior managers 

• Spends -30% time managing staff 

• Performs other duties as assigned 

QUALIFICATIONS: 

• Bachelor's Degree or equivalent required in a scientific relevant field, PMP certification preferred 

• Advanced proficiency in job related technical skills 

• 7 years minimum experience 

• Demonstrated experience managing and leading people to achieve aggressive timelines with high quality 

• Highly advanced in the management and execution of clinical studies/trials/labs/ including management of vendors, central labs and/or CROS 

• Proven record of working effectively with and across business areas (clinical science, medical affairs, research & development, finance, regulatory, legal, sales, contracting, business development, etc.) 

• Expert in technical knowledge required to lead a Clinical Trial organization 

• Employee must complete training relating to HIPAA/PHI privacy, General Policies and Procedure Compliance training and security training as soon as possible but not later than the first 30 days of hire.

KNOWLEDGE, SKILLS, AND ABILITIES:

• Learns and applies in-depth knowledge of Natera's business and corporate objectives to analyze situations and available data in order to make effective recommendations on project status to Sr. Management. 

• Exercises solid and mature judgment to escalate issues in a timely manner 

• Keeps senior management apprised of business-critical risks and proactively develops comprehensive mitigation plans 

• Requires the ability to change the thinking of, or gain acceptance from others in sensitive situations without damage to relationships 

• Provides feedback to both direct reports and management in a respectful and thoughtful way in order to achieve goals and deliverables aligned with departmental and corporate goals and objectives 

• Makes independent decisions pertaining to management and execution of assigned projects. Decisions made impact the Clinical Operations organization and Natera's expenditure of additional time, resources and/or funding 

• Represents assigned projects/studies to Natera Sr. Management 

• Has frequent contact with external parties (e.g, KOLS or external study Sponsors) and is viewed as a respected representative of Natera 

• Expertise and current training in Good Clinical Practice (GCP) 

• Strong project management, organizational and communication skills 

PHYSICAL DEMANDS & WORK ENVIRONMENT: 

• Duties are typically performed in an office setting. 

• This position requires the ability to use a computer keyboard, communicate over the telephone and read printed material. 

• Duties may require working outside normal working hours (evenings and weekends) at times. 

Travel required for this position: 

No or Yes: If yes state anticipated percent for travel: Up to 25% 

OUR OPPORTUNITY

Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives.

The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.

WHAT WE OFFER

Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program!

For more information, visit www.natera.com.

Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide.

All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws.

If you are based in California, we encourage you to read this important information for California residents. 

Link: https://www.natera.com/notice-of-data-collection-california-residents/

Please be advised that Natera will reach out to candidates with a @natera.com email domain ONLY. Email communications from all other domain names are not from Natera or its employees and are fraudulent. Natera does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. Natera takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes.

For more information:
- BBB announcement on job scams 
- FBI Cyber Crime resource page