Director, Program Clinical Delivery Lead 1 1

Work Your Magic with us!  

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

Your role

• Accountable for the delivery and quality of Phase I-IV, Epidemiology and Real World Evidence Company Sponsored Studies; Collaborative Research Studies; Investigator Sponsored Studies, Early Access Programs and other reseach activities [as applicable across assigned program(s)/product(s)]
• Provide leadership, strategic direction and operational oversight for Clinical Site Lead (CSL) and/or Clinical Research Manager (CRM) activities across assigned program(s)/ study(ies) in response to quality and performance oversight measures and trends
• Serve as the operational delivery expert for the program(s)/study(ies) and promote data-driven, realistic planning at the site and study level. Drive delivery-focussed accountability and ownership amongst key external (CRO) and internal partners as appropriate e.g. CSLs, CRMs, Clinical Trial Leads (CTLs), Compound Operation Leads (COLs), GMA Lead(s) etc.
• Facilitate identification and implementation of operational excellence strategies across program(s)/study(ies) - leveraging expertise within Global Development Operations (GDO) and other partner functions
• Drive proactive risk-based site oversight/study management practices and quality risk oversight and management across all stages of study delivery
• Ensure timely and appropriate escalation of trends, issues and risks within the Clinical Operations Team/Study Team/ Global Medical Affairs Team, department Leadership Team and/or senior management as appropriate
• Promote solution-orientated thinking and issue resolution at the country/study/program team level. Provide an escalation pathway to ensure program/study-specific major observations from CSLs/CRMs are relayed to and followed up by the appropriate internal and/or external business partners
• Support program/product/study-specific onboarding for new CDPC team members and contribute to enhancing their site/study management capabilities/skills
• Promote product knowledge, collaboration and information channelling; contribute to best practice guidance to drive consistency in the management of sites/studies
• Provide link between CSLs/CRMs and Global functions, being single point of contact for operational topics and escalations, support information channeling and facilitating solutions at the program level
• Lead regular calls with CSLs/CRMs working on study and/or other activities within the assigned program(s)
• Participate in Investigator/Study Coordinator Meetings and promote information sharing with the CSLs/CRMs as needed

As a member of the Clinical Trial Team for Clinical Development Studies:

• Represent the CSL group at the Clinical Operations Team (COT)/Clinical Trial Team (CTT) via:
  • Regular review meetings of study/site performance and quality metrics and the associated strategic action planning
  • Ad hoc interactions to address immediate issues
  • Other COT/CTT meetings as appropriate e.g. kick-off meeting
• Consolidate data-driven, CSL assessment of country and site selection proposals, ensuring quality and consistency across regions and countries to support CTT decision making; inform CSLs of resulting choices of regions/countries/sites
• Lead activities with internal and external stakeholders to proactively gather and integrate patient and physician insights into study design and conduct e.g. utilising Patient and Site advisory boards, social media campaigns, surveys, interactions with patient advocacy groups/organisations etc
• Design country start-up strategy in consultation with the Start-up Solutions Team and Country Start-up Specialists (CSS), and in alignment with the CTL(s) and CRO(s). Work closely with the CSL to oversee and ensure delivery at the site and country level
• Design patient and site centric recruitment and retention strategies, in consultation with the CTL and CRO/Vendor(s), and in alignment with the study and company diversity and inclusion objectives:
  • Lead identification and implementation of optimal solutions, considering program and study characteristics, with clearly delineated key performance indicators to deliver tangible impact and drive study execution e.g. utilising digital channels, biomarker-driven recruitment services and Decentralised Clinical Trial (DCT) capabilities such as telemedicine, mobile health applications, wearable sensors, direct to patient medication, etc.
  • Oversee service providers to ensure successful implementation within agreed timelines, budget, and quality
• Establish monitoring strategy, including management of identified risks, in collaboration with the CTL(s) and CRO(s) and incorporating principles of a risk-based quality management approach. Ensure monitoring strategy is updated in response to changes of external environment and/or availability of internal data
• Utilise site performance and quality data analytics to drive proactive, risk-based site oversight practices and quality risk oversight and management across all stages of study delivery
  • Develop, implement and follow up on robust Site Oversight Plans, in collaboration with the CTL(s) and working closely with the respective CSLs
  • Identify and encourage use of data-driven oversight tools and methods at the site and study level
  • Identify trends and issues within/across assigned study(ies) which may impact key study deliverables (e.g. timelines/quality/costs) and work with CSLs, CTLs, Data Managers, Clinical Lead(s) and other relevant business partners to implement action plans to resolve and/or mitigate

Local/Regional Studies and Early Access

• Oversee Company Sponsored Studies, Collaborative Research Studies and Investigator Sponsored Studies across the portfolio in regards of set-up, conduct and delivery per applicable Governance approvals and contractural obligations – including any agreed quality and/or safety data exchange expectations [as applicable across assigned program(s)/product(s)]
• Act as the global operations lead for Early Access (EA) activities, partnering with Medical Affairs to co-lead a multi-functional team accountable for implementing the agreed EA strategy including vendor selection and management activities (if applicable); ensure regular status updates are shared with GMA, CDPC and ICSO Leadership (and beyond as required)
• Work closely with GMA Lead(s) to track overall progress/quality and milestone performance and ensure issues are addressed immediately in priority studies
• Participate in GMA/Launch/Brand Team meetings (as appropriate) to provide operational expertise and promote information sharing with the CRMs as needed
• Represent CDPC at Governance Boards e.g. GMDB, iPRC etc, specifically through review of CRM operational plans and providing guidance to ensuring realistic ‘fit for purpose‘ study feasibility (timelines, cost, resources)
• Review program level CML Dashboard and Finance Tool on a monthly basis to ensure timely risk management and mitigation
• Work closely with CRMs and other functions as needed to support the financial planning exercise at the program level

Who you are

• Medical or Life Sciences degree in a clinical research related discipline or equivalent
• Clinical operations experience – ideally across Phases (I-IV)
• Expert knowledge of clinical development (principles and concepts as well as regulatory environment e.g., ICH GCP and applicable regional/local regulations)
• Oncology and/or Neurology and/or Immunology TA experience desired
• Extensive (12+ years) professional and project management experience in clinical research in a CRO, pharma or biotech company including site management/oversight, clinical study planning and conduct

Job specific Compentencies and Skills

• Adaptability / Flexibility, Critical Thinking, Strong Communication Skills, Analytical Skills, Business Partnering, Clinical Trials Knowledge, Influencing Skills, Strategic Thinking, Therapeutic Area Knowledge
• Ability to work independently on assigned tasks or projects
• Aptitude to interpret outputs from analytical tools to enhance and improve study execution
• Ability to assess risk, solve problems and take decisions
• Demonstrated excellent organizational ability: time management, prioritization, able to handle and oversee multiple tasks simultaneously
• Strategic thinking beyond own function; is familiar with and considers overall business objectives and company strategy
• Outstanding leadership skills:
  • To direct, influence and motivate people
  • To ensure high level of harmonisation and excellence
  • To drive multiple interfaces across (a) program(s)/study(ies)
• Approaches change positively; adapts behaviour or work methods in response to new information, changing conditions, or unexpected obstacles
• Demonstrated excellent interpersonal skills
• Highly self-motivated and proactive, willing and able to take on responsibility
• Strong cultural awareness
• Comfortable working in a fast‐paced environment where speed is paramount
• Fluency in English (oral and written) plus local language
• Position may require domestic/international travel up to 20% of time

This position can be filled in Europe or the US.

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
 
Apply now and become a part of our diverse team!