Senior Director, Drug Development Services at ICON plc · US

Senior Director, Drug Development Services

Location: US, Blue Bell (ICON) · Office or Home

Senior Director, Drug Development Services ( Womens Health)- Blue Bell,- REMOTE

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

Sr Director, DDS (Women's Health and Reproductive Medicine- non Oncology)

Role Purpose

Provide therapeutic, scientific and clinical-development leadership for the Women’s Health & Reproductive Medicine initiative under Elevate. The Therapeutic Expert will translate deep disease-area expertise and emerging scientific insight into differentiated development strategies, strengthen ICON’s sponsor-facing proposition, and ensure that Women’s Health opportunities are scientifically credible, patient-centred, operationally feasible and commercially relevant. This aligns with the Elevate strategy to build an integrated Women’s Health platform spanning scientific leadership, regulatory strategy, commercial intelligence and delivery excellence.

Key Responsibilities

• Therapeutic Strategy: Define and refine priority indications and scientific areas of focus based on unmet need, emerging science, sponsor pipelines, competitive activity and ICON capabilities.
• Clinical Development Strategy: Provide expert input into development plans, protocols and trial design, including patient populations, endpoints, biomarkers, PROs, digital measures, reproductive considerations and clinically meaningful outcomes.
• Regulatory Strategy: Partner with Global Regulatory Affairs to interpret evolving FDA, EMA, MHRA and other regulatory expectations and develop differentiated strategies in areas where Women’s Health development pathways remain insufficiently defined. Regulatory thought leadership is an explicit component of the Elevate initiative.
• Proposal & Bid-Defence Leadership: Provide senior therapeutic input to strategic RFPs, proposals, sponsor solution meetings and bid defences, translating scientific knowledge into compelling and executable clinical-development strategies.
• Feasibility, Site & Patient Strategy: Provide therapeutic oversight of feasibility assumptions, patient pathways, recruitment challenges and specialist site strategies, including gynaecology, IVF/ART and maternal-fetal medicine referral networks where appropriate.
• Patient-Centred Development: Ensure patient needs and Women’s Health-specific considerations are incorporated into protocol design, participation models, recruitment, retention and endpoint strategies.
• Capability & Evidence Development: Build and maintain indication-specific scientific content, evidence, case studies and proof points that demonstrate ICON’s Women’s Health expertise and support sponsor engagement.
• Pipeline & Competitive Intelligence: Monitor emerging mechanisms, assets, sponsors, competitors and scientific inflection points to identify future areas of opportunity and inform prioritisation of ICON investment.
• Thought Leadership & External Engagement: Strengthen ICON’s external scientific profile through KOL and investigator engagement, advisory boards, congresses, publications, webinars and relationships with academic, biotech and Women’s Health innovation networks.
• Internal SME Network: Identify and connect relevant expertise across ICON, particularly reproductive medicine, gynaecology, maternal-fetal medicine, endocrinology/metabolism, immunology, neuroscience, oncology, biomarkers, devices and digital health, creating an accessible network to support sponsor and study needs.
• Commercial Partnership: Partner with Business Development and account teams to identify high-value sponsors and assets, support early scientific engagement and develop sponsor-specific therapeutic value propositions.
• Governance & Strategic Readiness: Represent the therapeutic perspective within Elevate governance, identify capability gaps and assess scientific readiness of priority indications and propositions before external activation. The existing initiative includes a formal readiness concept encompassing evidence, resources, feasibility/site strategies, proposals and training.

Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.

Visit our careers site to read more about the benefits ICON offers.

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.

Are you a current ICON Employee? Please click here to apply