For our client, a leading international pharmaceutical company in Basel, we are looking or a dynamic personality in the function of
Implementation & Operations Lead (m/f), Basel, 100%
The OMA (Oncology Medical Affairs) Third Party Implementation & Operations Lead has the overall accountability for Third Party implementation of the Medical Affairs TP Engagement and Governance model ensuring compliance, capability and capacity enhancement to drive a consistent Third Party engagement and oversight. This in close collaboration with OMA Governance and Compliance Function, notably Governance Leads, OMA Operations and Scientific Engagement Function, Global Medical Affairs Pharma (GMA), Procurement, Quality Assurance and External Development Operations (EDO).
Furthermore, the OMA Third Party (TP) Implementation & Operations Lead will act as OMA Single Point Of Contact (SPOC) and SME on Third Party related activities eg TP Qualifications & Assessments, and representing OMA accordingly.
- Implementation Lead of Third Party Engagement and Oversight Program, with a special focus on Governance, that includes GOP & SQA rollout, in line with new Medical Affairs Third Party Operating model.
- Implementation Lead accountable to rollout the Medical Third Party Engagement Guiding tool at G/R/L level, and also acting as the SPOC for all related activities.
- Accountable to design and implement the Governance & Oversight framework fo the Medical Affairs Third Parties, in close collaboration with the "activity owners" and respective functions (eg ESPQA)
- OMA Third Party (TP) Implementation & Operations Lead will provide overall leadership, guidance and support to regional and local resources responsible for Medical Affairs Third Party qualification and oversight, in line with relevant GOPs
- Review and update Third Party / ESP (Vendor) partnering strategy jointly with procurement and the regional and local medical teams
- Single Point Of Contact (SPOC) to Medical Affairs on Third Party and ESP (Vendor) engagements, governance and oversight
- Bachelor's degree required; Relevant advanced degree (MBA, PharmD, MD or PhD preferred)
- 10+ years relevant industry experience, including expertise in clinical operations leadership of multidisciplinary teams, experience management outsourced trial activities at an operational and strategic level
- Proven people leadership in ESP management
- Experience with clinical processes and associated ESP services, with excellent understanding trial management, trial monitoring and overall integration of clinical data system and processes
- Strong technical and problem solving skills Excellent understanding of clinical trial methodology, GCP and medical terminology
- Excellent understanding of clinical dev., quality & regulatory standards and policies relevant to defined Services
- Provide thought-leading insights to the competitive environment and internal partner interfaces
- Outstanding skills to facilitate/optimize contribution of team members as individuals and members of cohesive team
- Excellent interpersonal and communication skills, able to naturally bridge scientific and business participants; Track record in enabling effective international collaboration
- English: fluent written and spoken
Place of work: Basel
Start date: April 2021
End of assignment: March 2022
Please apply online. For further information about the position, please contact your Kelly recruiter, Mrs Insa Voss (+41 61 270 80 07).