Associate Director, Global Medical Affairs Lead (Solid Tumor)

Overview

The Associate Director is a core member of the Global Medical Affairs (GMA) Solid Tumors team within the CDMA, R&D Organization, and serves as the in-house clinical and scientific expert for one or more assets and disease areas. The role holds medical accountability for the company's externally-conducted research portfolio, including specific investigator-sponsored trials (ISTs), collaborative and consortium studies, and translational collaborations; and owns the evidence strategy required to achieve inclusion and favorable positioning of company data in clinical practice guidelines and drug compendia.

Responsibilities

• Own assigned activities of determined ISTs and research collaborations including scientific review, protocol refinement, contracting and budget support, milestone tracking, data delivery, and publication.
• Serve as the medical/scientific point of contact for investigators and collaborating institutions, ensuring sites understand and adhere to the clinical and scientific nuances of the protocol: eligibility intent, assessment schedules, biomarker and specimen handling, endpoint definitions, and safety reporting expectations.
• Proactively shape the external research portfolio: define the questions the company needs answered externally (populations, sequences, combinations, real-world settings, underrepresented subgroups) and solicit proposals accordingly.
• Lead the setup, scientific discussion, design, and implementation of clinical and translational protocols within collaborative frameworks, including endpoint selection, statistical considerations, and biomarker/translational plans.
• Translate strategic scientific objectives into executable study designs for complex trials — identifying optimal development pathways, expansion opportunities, and differentiating positioning that maximizes the asset's clinical and commercial value.
• Act as Medical Study Lead for designated GMA-sponsored studies (tumor-, asset-, or indication-specific), with accountability for medical monitoring input, protocol amendments, data review, interpretation, and reporting.
• Partner with Translational Medicine and Clinical Sciences (Biostatistics, Clinical Pharmacology, etc) to design and execute non-clinical and translational data generation strategies where program needs require it.
• Identify and engage qualified investigators and sites with demonstrated recruitment capability, relevant patient populations, and translational capacity.
• Own the guideline strategy for assigned assets: map current guideline language, define the target language, and identify the specific evidentiary gaps that stand between the two.
• Build and maintain a guideline evidence roadmap that sequences pivotal, supportive, IST, and RWE datasets against published panel review cycles, so that peer-reviewed publication and congress presentation of each dataset land ahead of the relevant review window.
• Prepare, coordinate, and submit formal information requests and data submissions to guidelines and compendia bodies, working through the designated non-promotional submission channels and in partnership with Regulatory Affairs, Legal/Compliance, Publications. All guideline body interactions are conducted exclusively through formal, documented, non-promotional submission processes. Direct advocacy toward individual panel members is out of scope and expressly excluded from this role's activities.
• Ensure every submission package is complete and defensible: full publications, congress abstracts and presentations, prescribing information, and a clear articulation of the clinical question addressed, the strength of evidence, and the proposed category of recommendation and evidence.
• Monitor guideline versioning across all relevant assets and competitors; analyze changes for strategic implications and communicate them to Medical, Commercial, Access, and Development leadership with a recommended response.
• Anticipate and address the evidentiary objections a panel is most likely to raise (sample size, single-arm design, cross-trial comparison, subgroup analyses, generalizability) and build the supporting evidence to close them.
• Conduct continuous review and interpretation of emerging internal and external data, and contribute to the scientific review process across the data generation workstream for both clinical and RWE publications.
• Support publication planning and execution for assigned ISTs and collaborations, ensuring alignment with guideline and access milestones, adherence to GPP and authorship standards, and appropriate scientific rigor.
• Maintain a current, structured evidence base for assigned assets and diseases — epidemiology, disease landscape, current and emerging therapeutic strategies, treatment algorithms, preclinical and clinical data, competitor evidence, literature, and guidelines — and translate it into insight rather than summary.
• Gather and synthesize clinical, medical, and scientific insights from investigators, KOLs, and congresses to inform strategy, study design, and prioritization.
• Act as a primary medical liaison for KOLs, investigators, cooperative groups, academic consortia, and patient advocacy organizations within the assigned therapeutic area.
• Represent Menarini–Stemline at major international congresses (ASCO, ESMO, AACR, and others as relevant), including scientific exchange, data presentation support, etc.
• Partner closely with Early and Late-Stage Development (Oncology R&D), Regulatory Affairs, Market Access, HEOR, Biostatistics, Commercial, and in-market Medical teams to build alignment on data generation approach, site selection, analysis plans, communication strategy, and access support.
• Engage senior stakeholders, including executive leadership, with insights, data execution plans, and clear recommendations that shape portfolio and asset-level decisions.

Qualifications

• Advanced scientific or medical degree required: MD, PhD in a life-science discipline, or PharmD. Board certification or specialty training in medical oncology, hematology-oncology, or a related clinical discipline is strongly preferred.
• 5+ years of combined experience across biopharmaceutical industry, academic clinical research, or a comparable environment in oncology.
• Demonstrated ownership of clinical or translational studies through the full lifecycle (design, protocol authoring, execution oversight, data interpretation, and publication) not solely operational or monitoring involvement.
• Direct experience with externally-sponsored or collaborative research: investigator-sponsored trials, cooperative group or consortium studies, academic partnerships, or equivalent. Familiarity with proposal review, scientific evaluation, and study governance in an external-research context.
• Working knowledge of GCP, ICH guidelines, and the regulatory and compliance framework governing medical affairs activity and non-promotional scientific exchange.
• Demonstrated ability to build and sustain credible scientific relationships with clinical investigators and key opinion leaders.
• Solid tumor expertise, with depth in breast cancer and current command of the treatment landscape, standards of care, and evolving evidence.
• Exposure to real-world evidence generation, translational/biomarker research, or health economics and outcomes work.
• Scientific judgment: able to assess the strength and limitations of a dataset independently and articulate what it does and does not support.
• Strategic translation: converts scientific objectives into executable study designs and evidence roadmaps with defined milestones.
• Execution discipline: manages a multi-study portfolio against timelines, budget, and deliverables, and escalates with a proposed solution rather than a problem.
• Written and verbal communication of a standard suitable for regulatory documents, manuscripts, and executive-level recommendations.
• Willingness to travel (domestic and international), approximately 20%, including congresses, site visits, HCPs engagements.

Please note: This position is classified as a corporate office position. In accordance with the New York state 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: $210,000-$229,000 annually