Director/Senior Director, Clinical Scientist, Solid Tumor

Overview

We are seeking a Clinical Scientist (Director/Senior Director), to join our Solid Tumor Clinical Development department. This role contributes/leads to the development, evaluation, planning, and execution of clinical studies and ensures scientific integrity and interpretation of study data of a clinical development program. The Sr. Director, Clinical Scientist will participate in a matrix environment as part of a cross-functional team and may contribute to candidate development projects through early and/or late phase development. The This role will collaborate closely with Clinical Development Medical Director(s) to provide scientific expertise necessary to design and deliver on clinical studies and/or programs.

Domestic and international travel may be required (approximately 5-10%)

Responsibilities

The Clinical Scientist will play a critical role in the planning, execution, and reporting of clinical trials, primarily in oncology. Key responsibilities include:

• Clinical Data Management & Safety:

  • Perform clinical/medical data review, analysis, and interpretation of study results, ensuring accurate data reporting.
  • Identify study issues by monitoring emerging clinical data related to safety, efficacy, and PK/PD.
  • Design and execute clinical data review plans in collaboration with cross-functional teams, including evaluating specific data trends and performing manual coding of adverse events and concomitant medications as needed.
  • Ensure processes and procedures are in place for clinical safety monitoring and patient safety.
  • Work closely with the Medical Monitor to keep them informed of pertinent study information, including safety and efficacy data.

• Study Document Development & Regulatory Submissions:

  • Contribute to the authoring of clinical study protocols and Informed Consent Forms (ICFs)/amendments.
  • Review and draft a variety of study and regulatory documents such as Briefing Books, Investigator Brochures (IB), Clinical Study Reports (CSRs), and clinical sections of regulatory submissions (e.g., IND, annual reports).
  • Maintain appropriate clinical documentation and submit clinical documents to the Trial Master File (TMF).
  • Ensure prompt, quality responses to IRBs/ERCs, IDMCs, etc.

• Collaboration & Communication:

  • Collaborate and liaise with external partners (e.g., Key Opinion Leaders/KOLs) in various settings (1:1 meetings, investigator meetings).
  • In conjunction with the Medical Director, establish and oversee the management of study committees (e.g., Steering Committee, IDMC).
  • Serve as the Clinical Science Representative on assigned cross-functional teams.
  • Provide regular and timely updates to management regarding study activities and data status.
  • Anticipate study-related activities or barriers and present potential resolutions to leadership.

• Training & Presentations:

  • Develop and present site and CRA training materials at Site Initiation Visits (SIVs) and Investigator Meetings.
  • Develop presentations and communicate study data results internally and externally to investigators and at scientific conferences/symposia (abstracts, posters, publications).
  • Conduct literature reviews to interpret study data, inform next steps, and maintain current knowledge of the external scientific environment.

• Trial Operations Support:

  • Ensure Case Report Form (CRF) design adequately supports data collection in alignment with the protocol, collaborating with Data Management/Programming and potentially participating in User Acceptance Testing (UAT).
  • May lead or support trial-level activities for one or more trials with necessary supervision.

Qualifications

• 5+ years’ experience in drug development as a clinical scientist or related role in pharmaceutical/biotech industry.

• Advanced degree (e.g. MS, PharmD., PhD) or equivalent experience is required

• Experience in late phase solid tumor oncology is required.

• Proficient with Microsoft Word/Excel/PowerPoint, EDC systems (e.g. Medidata RAVE), and data review tools (e.g., patient profiles, report generating tools)

• Knowledge of GCP, ICH Guidelines and current US FDA regulations.

• Willingness to work Eastern Time Zone (US) hours.

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 $215k-$275k (plus (incentive compensation) package). 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.

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.

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