MEDICAL DIRECTOR - MEDICAL AFFAIRS
POSITION SUMMARY:
The Medical Director Medical Affairs provides strategic medical affairs leadership for azenosertib - bringing scientific insight, Health Economics & Outcomes Research (HEOR) and Real-World Evidence (RWE) capabilities, supports Commercial in Value & Access topics through generation of RWE data and clinical evidence packages and external perspectives to the decisions that shape Medical Affairs goals and long-term value. This position will play a pivotal role in building the Medical Affairs functions as we advance our lead programs to commercialization. This individual will define the roadmap for our scientific narrative, drive clinical scientific messaging, foster key relationships with healthcare professionals (HCPs), key opinion leaders (KOLs), and patient advocacy groups and ensure high-integrity, compliant processes for stakeholder engagement. They will lead cross-functional efforts to bridge clinical development with commercialization readiness, fostering deep relationships and evidence generation strategies necessary to drive program success.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Medical strategy & asset leadership
- Responsible for the global Medical Affairs medical strategy for azenosertib late-stage assets across mid to late-stage development.
- Serves as Medical Affairs asset lead, delivering objective medical and scientific input to disease education strategy, overseeing Phase IV studies, and ensuring all scientific and promotional materials are compliant and accurate.
- Designs and implements Medical Affairs plans to support pre-and post-launch activities.
Evidence generation & scientific communication
- Facilitates the medical evidence and scientific communication strategy, including integrated evidence plans, medical narratives, publication planning, and core scientific platforms.
- Aligns clinical data generation with external engagement and value/access evidence needs.
- Is responsible for and creating and evidence gap analysis
External stakeholder engagement
- Identifies and maps external experts across priority disease areas.
- Build and maintain strong peer- and eye-level relationships with HCPs, KOLs, and patient advocacy organizations
- Collaborate with the CMO to establish high-integrity, compliant processes for HCP and KOL engagement, ensuring adherence to regulatory guidelines (e.g., FDA, ICH)
- Provide strategic input to scientific communications, including publications, congress presentations, and medical information responses, aligned with medical messaging
- Provide scientific expertise to support commercialization readiness activities, including training, payer interactions, and real-world evidence initiatives
Cross-functional leadership
- Represents Medical Affairs on Appropriate Project Teams, governance forums, and key decision bodies as requested.
- Create and refine the clinical scientific and value story for azenosertib through internal consultations, external expert input, and data analysis to support program progression
- Work cross-functionally with clinical development, regulatory affairs, commercial, and quality teams to drive business impact and team success
Portfolio & business development support
- Shapes medical affairs IST discussions by articulating scientific differentiation, evidence risk, and opportunity.
KNOWLEDGE/SKILLS/ABILITIES REQUIRED:
- 8+ years of relevant experience with Advanced scientific degree, MD with board certification or foreign equivalent in Gynecological Oncology or Medical Oncology preferred (e.g. MD, PharmD, PhD). PhD, PharmD with extensive experience and proven success may be considered
- Advanced clinical and/or scientific knowledge in oncology with relevant gynecologic experience preferred
- Relevant pharmaceutical company experience within Medical Affairs with strong understanding of global development and access considerations preferred
- Proven ability to lead cross-functional medical affairs strategy in a complex matrix.
- Deep experience and commitment to excellence in medical affairs, with a proven track record in biotechnology or pharmaceuticals
- Experience working in a small company environment, thriving in dynamic, resource-constrained settings
- Passionate "can-do" mentality with evidence of high emotional intelligence (EQ) and collaborative teamwork
- Exceptional communication, presentation, and interpersonal skills to engage stakeholders at all levels
- Excellent knowledge and command of established and novel software tools including but not limited to the full MS office suite to continuously identify opportunities for innovation and efficiencies
- Strong understanding of regulatory compliance, including cGMP, ICH, and FDA guidelines
- Willingness to travel up to 30-40% for meetings, site visits, and conferences
- Ability to synthesize findings and clearly articulate implications from multiple sources of information, and to formulate strong, actionable recommendations
- Works independently with minimal supervision
- Ability to embrace Zentalis' patient-centric values, including highest ethical and compliance standards
- Experience with pre-launch and successful commercialization activities in a Medical Affairs capacity
- Global scope experience preferred
