Director/Senior Director, Global Regulatory Affairs, Oncology bei Menarini Group

The Director/Senior Director of Global Regulatory Affairs Oncology (Early Development and Lifecycle Strategy) is a leader in the Global Regulatory Affairs Oncology department and is a key contributor to the successful development of Stemline/Menarini’s pipeline. The Director, as a Global Regulatory Lead (GRL), is responsible for the implementation of the regulatory strategies for responsible products/projects and provides overall regulatory guidance and oversight for all assigned programs to obtain optimal labeling and the shortest timing to approval by Regulatory Agencies. All regulatory activities will be conducted keeping oncology patients in mind; meaning, he/she will keep abreast with US/EU regulations, key Health Authority guidance, regulatory precedents, and assess opportunities for leveraging expedited development pathways/regulatory mechanisms. At the Senior Director level, he/she is responsible to create and drive the Global Regulatory strategy for a product/projects) and ensure there is a robust regulatory foundation for the successful optimization of the product / project(s) in accordance with business priorities working closely with local and regional stakeholders (e.g., medical, marketing, market access) to ensure alignment on global strategy. All regulatory activities will be conducted keeping oncology patients in mind; meaning, he/she will keep abreast with US/EU regulations, key Health Authority guidance, regulatory precedents, and assess opportunities for leveraging expedited development pathways/regulatory mechanisms.

The position holder may be required to interact with key Regulatory Agencies. The assigned programs may have different levels of complexity with more than one indication, formulation, or external business partner.  The Senior Director may also be assigned specific project and/or department responsibilities and may have one or more direct reports.  He/she will be part of an international environment and is expected to actively contribute to developing the network and expanding the knowledge of the GRA Oncology team, including the mentoring of junior colleagues. #LI-MB1

• As part of the Global Regulatory Affairs Oncology team, directly manage and provide leadership and mentorship to a team of regulatory representatives (GRT) responsible for the assigned products.
• As an active member, participate in multi-disciplinary teams in order to define the development and regulatory strategies of assigned early, mid-and late-stage development programs.
• Collaborates with Global/Regional and Local (country) counterparts to ensure global/regional regulatory strategy is defined and executed upon for all projects within area of responsibility.
• Liaise with Health Authorities to negotiate Stemline’s regulatory strategy for alignment, as well as for all routine regulatory submissions and correspondence.
• Identifies and communicates potential risks associated with different strategic scenarios.
• Identifies regulatory requirements and trends across therapeutic area of responsibility and provides regulators guidance and expertise to global development team and/or higher governance in this area.
• Presents global regulatory strategies to senior management as applicable.
• Contributes to the development of the Target Product Profile in collaboration with other functional areas.
• Understands importance of regulatory documents for value and access discussions and partners with access functions to support access applications as needed.
• Leads the development of regulatory information across assigned products, covering clinical development, labelling, protocols, reports, presentations, and other documents (internal and external).
• Leads the strategy regarding the preparation, review, and submission of health authority documents as required, including investigational and marketing applications, responses to Health Authority requests, meeting requests, briefing packages, annual reports, etc.
• Ensures consistency/completeness/accuracy and adherence to regulations and applicable guidelines for all regulatory submissions.
• Manages submission plans and timelines to ensure approvals and development objectives are timely met.
• Leads the global/regional regulatory team and represents the region as needed in project teams providing regulatory expertise for assigned projects.
• May participate in regulatory review of potential in-licensing opportunities/participation in regulatory due diligence activities.
• Mentor and support development of regulatory colleagues within the department.

At Senior Director level, will also be responsible for: 

• Global Strategy Lead for regulatory implementation.
• May be the primary RA representative and responsible to their region in relation to overall project strategy including pre-clinical and clinical (working with local RA where required).
• Responsible for the Global regulatory strategy and ensuring alignment with Global commercial plans and priorities to optimize portfolio.
• Designs, coordinates, directs, and conducts all global regulatory interactions, including United States Food and Drug Administration (FDA) and European Medicines Agency (EMA) interactions and other competent health authorities.
• Responsible for regulatory interactions, and submissions, with strategic accountability for the regional filings while leveraging their GRT subject matter experts and endorsed by GRT.
• Trains, acts as mentor and ensures proactive communication and knowledge sharing of strategic regulatory topics with GRT and other relevant stakeholders.
• Acts as subject matter expert, as applicable.
• Challenges and improves existing procedures.
• Reviews relevant documents that will be included in regional /global regulatory applications/interactions in accordance with local and global regulatory guidance/legislation, as applicable, while leveraging GRT subject matter expertise.
• Manages coordination, preparation and timely submission and approval of various original and variation filings (e.g., INDs/CTAs, MAAs, NDAS/BLAs) for their region, working in a global collaborative manner. Ensures timely follow up and execution according to agreed timelines.
• Maintains expert knowledge of region and ICH guidance and familiarity with FDA/EMA/key international market regulations including Competitor intelligence/landscape.

• Minimum of 6 years of relevant Regulatory Affairs experience, with increasing responsibility demonstrated in previous roles (10+ years for Senior Director)
• Experience in an Oncology therapeutic area.
• Demonstrated Leadership skills in a complex matrix environment.
• Demonstrated people management skills.
• Proven track record of success bringing new oncology products to registration.
• Prior experience in leading teams in the development and execution submissions including INDs, CTAs, BLAs, NDAs, MAAs.
• Regulatory Lead and expert knowledge in or more major regions (US/EU preferred).
• Demonstrated experience in Japan/China/RoW.
• Exceptional interpersonal skills with the ability to work in a global environment, individually as well in multi-disciplinary team, and with external partners and regulators.
• Ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate with key stakeholders.
• Proven ability to consistently deliver within defined timelines, cost, and quality standards.
• Direct experience of interfacing with relevant regulatory authorities.
• Comfortable working in a matrix environment to achieve team goals and desired outcomes.
• Experience managing relationships with contractors and CROs is preferred.

Education

• Science based B.S. with requisite experience and demonstrated capability.
• Advanced degree (M.S.,PhD, PharmD) preferred

Preferred:

• Global Oncology Drug Development
• IND/CTA/NDA/BLA/MAA experience (Oncology)
• Regulatory risk assessment
• Due diligences
• Precision medicine/CDx
• People Management

Please note--this position is classified as a corporate office position. In accordance with the New York employer convenience rule, Stemline will withhold New York state income taxes for all corporate office employees, regardless of whether these employees work in New York or remotely. 

Base Salary Range of $185,000-$265,000.  Menarini Stemline offers generous compensation and benefits packages,  including Short- and Long-Term Incentive Programs,  Fidelity 401(k) (with company match), Anthem Premier PPO and HDHP insurance plans, Company paid Basic Life & AD&D insurance and pre-tax FSA/HSA programs. Menarini Stemline is committed to creating an inclusive environment for all employees.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.

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 70 countries and our products are sold in 140 locations 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 haematological and solid tumours. The acquisition of Stemline Therapeutics in June 2020, further strengthened Menarini’s oncology portfolio, adding both commercial and clinical-stage assets. Tagraxofusp is a novel, first in class targeted therapy for patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN) and to date, 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 leukaemia (AML), chronic myelomonocytic leukaemia (CMML), and myelofibrosis (MF). 

Additionally, Menarini received exclusive rights to commercialise Selinexor for the treatment of oncology indications in the European Union and other European countries (including the United Kingdom), Latin America and other key countries. Menarini has signed an exclusive licensing agreement with Karyopharm Therapeutics for the rights to commercialise an innovative therapeutic option in Europe, Latin America, Turkey, Russia, and CIS countries. Selinexor is a first-in-class, oral Selective Inhibitor of Nuclear export compound for the treatment of hematologic cancers and solid tumours. It is already marketed in the US for multiple myeloma and is under development for solid tumour indications. Selinexor is registered in the EU for both early and late lines.

Menarini entered into a global licence agreement with Radius Health to complete the development of Elacestrant, an oral SERD in late-stage Phase 3 development for hormone receptor-positive advanced breast cancer. Following a successful phase 3 study, Menarini Stemline received FDA approval in January 2023 under priority review and successfully oversaw a strong launch in February to the US market with the EMA review process concluded positively in September 2023. 

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 Tumour 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 has offered 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.