Senior Director, Drug Development Services

Senior Director, Drug Development Services

Location: Blue Bell

Reference: JR163399

About the role

Senior Director, Drug Development Services (Women’s 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.

• What ICON can offer you

• Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

• In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Benefits examples include:

• Various annual leave entitlements

• A range of health insurance offerings to suit you and your family’s needs

• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead

• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being

• Life assurance

• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

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

• At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

• If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here

• Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

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

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Location

Blue Bell

Reference: JR163399

vacancyopjusttionswidget.opt-Business Area

ICON Full Service & Corporate Support

Categories Drug / Device Regulatory Affairs

vacancyopjusttionswidget.opt-Remote Working

Remote or Office

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Description

• At ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us fulfill our mission to advance and improve patients' lives. We are curren