Biomarker Operations - Senior Manager

Headquartered in Carlsbad, California, and with offices in Boston, Massachusetts, and Dublin, Ireland, Ionis has been at work for more than three decades discovering medical breakthroughs that have redefined life for people with serious diseases. We are pioneers in RNA-targeted medicines, and our platform continues to revolutionize drug discovery and transform lives for patients with unmet needs.  With five currently marketed medicines for serious diseases and an expansive late-stage pipeline, we continue to build upon our groundbreaking innovations in science and technology to provide greater value to patients; and we are well positioned financially to deliver on our strategic goals.

At Ionis, we pride ourselves on cultivating a challenging, motivating and rewarding environment that fosters innovation and scientific excellence. We know our success is a direct result of the exceptional talent and dedication of our employees.

With an unprecedented opportunity to change the course of human health, we look to add diverse individuals, skill sets and perspectives to our exceptional team. We continue to invest time, money, and energy into making our onsite and remote work environments a place where solid and lasting relationships are built and where our culture and employees can thrive.

We are building on our rich history, and believe our greatest achievements are ahead of us.  We invite you to apply and join us if you’re passionate about the opportunity to have meaningful impact on patients in need, our employees, and our organization.  Experience and contribute to our unique culture while you develop and expand your career!

BIOMARKER OPERATIONS - SENIOR MANAGER

SUMMARY:

The Biomarker Operations Senior Manager will be responsible for sample operations strategy working directly on multiple clinical programs managing end-to-end operational planning ensuring sample shipping, receipt, and output of quality sample data in accordance with study protocols, regulatory requirements, and third party lab/analysis vendor specifications. 

RESPONSIBILITIES:

• Driving the implementation and execution of the clinical biomarker sample analysis for clinical programs 
• Contributing to external vendor contracting and procurement by helping to draft, review, and execute contracts and tracking invoices against work contracted and performed
• Contributes to the preparation of clinical documents such as clinical protocols, informed consent forms, lab manuals, QRCs, sample management plans, and early development plans
• Accountable for the oversight and management of clinical trial biomarker sample management planning, processing, tracking, shipping logistics, reconciliation, and life-cycle management, including long-term biobank management. Ensures chain-of-custody integrity and timely data deliverables
• Reviewing and supporting development of Data Transfer Agreements and blinding plans to ensure timely delivery of high-quality biomarker data to meet program deliverables
• Providing external vendor oversight of Contract Research Organizations tracking performance, quality, delivery and compliance
• Contributing to applicable bioanalytical sections of CSRs, IND/NDA summary documents, and other regulatory submissions.
• Represent biomarkers in operational meetings and research meetings which includes being readily available to advise on biomarker or study related updates and questions
• Forecast for current and future programs to ensure appropriate support for Ionis-owned programs

REQUIREMENTS:

• Requires a minimum of 5 years of related experience with a bachelor’s degree; or 3 years and a master’s degree; or equivalent work experience
• Project management and oversight of sample analysis supporting Phase 1-3 clinical studies in a Pharmaceutical/Biotech setting
• Comprehensive understanding and first-hand experience working in clinical trial processes, from study start-up to study closure. Ability to contribute to the development and review of clinical protocol, and ICF
• Ability to contribute to the development and review of Laboratory Service Agreements, Data Transfer Agreements, and blinding plans
• In depth understanding of clinical trial regulations and guidelines, including GCP, GLP, ICH and other global regulatory frameworks related to biomarker and bioanalytical data management
• Bioanalytical sample analysis experience including biomarker and/or PK/Immunogenicity experience. 
•  Advance knowledge of evolving regulatory requirements for biomarkers including ICH M10, FDA, and EMA guidelines
• Oversight of Contract Research Organizations including vendor selection/oversight, contracting/budgeting, monitoring of performance including Key Performance Indicators, etc
• Experience working with central laboratories to ensure proper sample receipt and shipment, and alignment on Laboratory Services Agreements and Manuals
• Proven ability to lead cross-functional teams and manage complex projects with multiple stakeholders
• Strong interpersonal skills to effectively collaborate with clinical, scientists, regulatory and other teams

ADDITIONAL SKILLS (PREFERRED, NOT REQUIRED) 

• Familiarity with project management tools, such as Smartsheet or similar software
• Experience with Veeva, Conga, and/or Coupa systems
• Knowledge of analytical platforms including but not limited to ligand-binding assays, mass spec, flow cytometry, and PCR techniques
• Experience with genetic testing,  biomarker safety analysis and IVDR compliance

Please visit our website, http://www.ionis.com for more information about Ionis and to apply for this position; reference requisition # IONIS003515

Ionis offers an excellent benefits package! Follow this link for more details: Ionis Benefits

Full Benefits Link: https://www.ionis.com/careers/working-at-ionis/#:~:text=our employee spotlight-,Benefits,-Employees are rewarded

The pay scale for this position is $92,245 to $116,588

NO PHONE CALLS PLEASE. PRINCIPALS ONLY.

Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.

Salary : $92,245 - $116,588