Associate Director, Clinical Quality Assurance

Menarini Group; Italia; Remoto; EUR 80.000 - 120.000; Tempo pieno

Descrizione del lavoro

Join Menarini Group as an Associate Director, Clinical Quality Assurance, where you will lead compliance efforts in clinical trials, ensuring GCP standards are met. This role involves evaluating clinical trial documentation, overseeing quality management, and preparing for regulatory inspections, significantly impacting oncology treatments.

Competenze

• 5+ years’ experience in the pharmaceutical industry.
• Oncology experience preferred.
• Registration as a Registered Assurance Quality Professional (RQAP) in GCP expected.

Mansioni

• Drive the assessment and investigation of quality issues, including root cause analysis.
• Lead pre-approval and routine regulatory inspection readiness activities.
• Oversee quality with Functional Lines and vendors.

Conoscenze

GCP Compliance

Regulatory Inspection Readiness

Quality Management

Formazione

Bachelor’s Degree in a scientific field

Master’s degree in clinical research

Descrizione del lavoro

Overview:

Job Title: Associate Director, Clinical Quality Assurance

Reports to: Executive Director, Quality Assurance

Location: EMEA Remote

Are you a meticulous QA professional passionate about ensuring the highest standards of GCP compliance in clinical trials? Do you thrive on driving quality improvements and preparing for regulatory inspections? Are you ready to make a significant impact on oncology treatments?

If so, join our team and be our next Associate Director, Clinical Quality Assurance, apply now!

Responsibilities:

About the Role:

We are seeking a highly motivated and experienced Associate Director, Clinical Quality Assurance to join our team, reporting to the Executive Director, Quality Assurance. This critical role will serve as the lead for compliance with GCP requirements for specific clinical programs and trials , providing essential GCP QA support on an as-needed basis to different trials. Your responsibilities will span from QA review of key clinical trial documentation (e.g., Clinical Protocol, Investigator’s Brochure, Informed Consent Form, Trial Master File) , as well as relevant submission documentation. You will facilitate the assessment and investigation of quality issues by driving root cause analysis and remediation, providing expertise and recommendations, and ensuring timely closure of quality issues. Furthermore, you will facilitate the review of potential Serious Breach and Urgent Safety Measure assessments arising from assigned clinical programs. This is an exciting opportunity to contribute to building and shaping Menarini Stemline’s Oncology business.

Responsibilities:

• Responsible for QA review of key clinical trial documentation (e.g., Clinical Protocol, Investigator’s Brochure, Informed Consent Form, Trial Master File).
• Drive the assessment and investigation of quality issues, including root cause analysis, remediation, and timely closure.
• Facilitate the review of potential Serious Breach and Urgent Safety Measure assessments.
• Coordinate GCP/GVP vendor audits and contribute to the impartial management of the audit program, including risk-based site selection and ensuring proper audit execution and closure. Ensure that any issues identified through audits that are not resolved in time for audit close-out are appropriately tracked and managed as CAPA. You will also determine if clinical site audit observations may represent trial-wide or program-wide risks and ensure impact/risk assessments and trial-wide/program-wide CAPAs are adequate.
• Oversee quality with Functional Lines and vendors, including facilitating Quality Oversight Committee meetings and providing input to Quality Systems reviews.
• Collaborate on the implementation of risk-based quality management (RBQM) for specific studies, covering critical data identification, QTLs, and reporting.
• Lead pre-approval and routine regulatory inspection readiness activities, including risk analysis, strategy development, program management, and providing key support during and after Health Authority inspections.
• Provide guidance, training, and input on compliance issues using expertise in GCP, clinical development, and industry best practices.
• Support GCP SOP development, implementation, and maintenance by serving as a Quality reviewer.

Qualifications:

Qualifications:

• Bachelor’s Degree in a scientific field, master’s degree in clinical research a plus.
• 5+ years’ experience in the pharmaceutical industry.
• Oncology experience preferred.
• Registration as a Registered Assurance Quality Professional (RQAP) in GCP expected.
• Working knowledge of clinical research practices within the US and the EU/UK, experience in other regions will be considered a plus.

As a person, you are adaptable, able to develop creative and effective solutions to solve problems.

Elevate Your Impact:

If you are a passionate and skilled project management professional seeking a challenging and rewarding opportunity to contribute to the advancement of oncology treatments, we encourage you to apply. Join us and be a part of a team that is making a difference in the lives of patients.

The Company

Founded in 1886 in Naples under the name of Farmacia Internazionale, Menarini moved in 1915 to Florence where the Group’s headquarters are still located today. High quality therapeutics and diagnostics solutions for patients, ethics as our underlying principle, dedication to innovation and advancement, strong people centricity and environmental sustainability. These five pillars form the foundation of the Menarini Group, an Italian pharmaceutical company with nearly 135 years of history.

The Menarini Group is present in 140 countries around the world. Its companies span from Europe to Asia, to Africa and the Middle East, to Central America and to the United States where with the acquisition of Stemline Therapeutics, a NASDAQ-listed biopharmaceutical company, the company marked its entry into the US oncology market.

Thanks to the valuable contribution of around 18,000 employees, every year more than 500 million packs of drugs are produced at the Group's 18 manufacturing sites including a biotech plant for the manufacturing of monoclonal antibodies that also serves external clients distributed across 6 continents.

Menarini has made a strong commitment to oncology, investing in a pipeline of five investigational compounds for the treatment of a variety of hematological and solid tumors. The acquisition of Stemline Therapeutics in June 2020, further strengthened Menarini’s oncology portfolio, adding both commercial and clinical-stage assets. ELZONRIS (tagraxofusp) is a novel, first in class targeted therapy for patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN). To date, Elzonris is the only approved treatment for BPDCN in the U.S. and EU, and the first and only approved CD123-targeted therapy. Tagraxofusp is also being evaluated as both a single agent and in combination, in other CD123+ indications, including acute myeloid leukemia (AML), chronic myelomonocytic leukemia (CMML), and myelofibrosis (MF).

In Europe, Menarini Stemline also commercializes Nexpovio, a first-in-class oral exportin 1 (XPO1) inhibitor for multiple myeloma in the UK, Switzerland, European Economic Area, CIS countries, Latin America and Turkey. Nexpovio is approved for use in combination with dexamethasone for treatment of multiple myeloma in adult patients who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory agents and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy; and in combination with bortezomib and dexamethasone for treatment of adult patients with multiple myeloma who have received at least one prior therapy. Nexpovio’s marketing authorization is valid in the EU Member States as well as Iceland, Liechtenstein, Norway, and Northern Ireland, and it has been commercially available in Germany and Austria since the fourth quarter of 2022.

In January 2023, Stemline Therapeutics, received U.S. FDA approval for ORSERDU (elacestrant), the first and only treatment specifically indicated for postmenopausal women or adult men with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer. ESR1 mutations cause tumors to become resistant to endocrine therapy, and up to 40% of patients with ER+, HER2- mBC have tumors which harbor this mutation. ORSERDU is the first endocrine innovation in more than 20 years, and specifically addresses a major unmet need. Elacestrant is also being investigated in several clinical trials in metastatic breast cancer disease, alone or in combination with other therapies. A Marketing Authorization Application (MAA) is currently under review by the European Medicines Agency (EMA).

Menarini’s commitment to oncology is also reflected in the investments made in the liquid biopsy diagnostic field through its affiliate Menarini Silicon Biosystems (MSB), a pioneer in rare cell analysis and non-invasive, advanced diagnostic solutions. MSB’s CELLSEARCH Circulating Tumor Cell (CTC) Test is the first and only clinically validated blood test cleared by the U.S. Food & Drug Administration (FDA) for detecting and counting CTCs in metastatic breast, prostate, and colorectal cancer when used in conjunction with other clinical monitoring methods.

Since 2021, MSB is offering in the US a menu of non-invasive Laboratory Developed Tests (LDTs) provided through its CLIA/CAP accredited US-based Lab. The services include CMC enumeration, CTC enumeration and PDL-1/HER2 biomarker and offer a minimally invasive approach to follow cancer patient’s therapeutic journey.

In 2022, the company launched the CELLSEARCH Circulating Multiple Myeloma Cell (CMMC) Enumeration LDT, the first-of-its-kind, which directly measures levels of plasma cells in the blood of patients. This test provides new, complementary information to that of the bone marrow biopsy and other standard-of-care measures. Due to its minimally invasive nature, it can be performed serially to assess plasma cell burden without requiring repeated bone marrow biopsies.

Menarini's vision and uniqueness in oncology is to bring together innovative therapeutic solutions and advanced liquid biopsy-based diagnostics for faster, more effective and precise patient management.

It is an exciting time in the company’s development and an excellent opportunity for individuals joining us to contribute to building and shaping Menarini Stemline’s Oncology business.