A Director, Clinical Operations (Medical Affairs) opportunity has opened to join a global Pharmaceutical company where you can be based in England (London), Germany (West Germany), France (Paris), Italy (Milan), or Spain (Barcelona). This position is a mixture of operations and strategy where you'll be managing a team of 5 to 10 Clinical Operations professionals globally whilst driving changes in processes and continuous improvement of business model changes. This is a perfect role for a someone with a strong Clinical Operations and late phase/ Medical Affairs background who wants to be a key player into a credible Pharma company's transformation.
Responsibilities:
- To assess the need, recruit, manage, mentor, train, review, develop, set objectives, and assess performance of the clinical Operations team in the Global Medical Affairs function.
- To provide guidance to therapy area Medical Directors prior to MA review boards on the study design
- To provide guidance to your CPM/ CTA teams in-charge of studies when defining study operations objectives, internal & external resourcing, budget, Service Providers selection, study deliverables, tools and compliance requirements (RA, PV, QA).
- To provide guidance in study execution and closing and ensure study plan, budget and deliverables are delivered on time and with expected quality.
- To lead in fostering and developing a team approach to all activities associated with the implementation of clinical studies.
- To develop and maintain, for operational management and reporting purposes, a dashboard to track, reconcile and manage the planning, deliverables and budgets about clinical studies in the area of responsibility and ensure all needed information is shared with key internal stakeholders
- To proactively act as contact point for internal functions within and provide operational expertise to all of them.
- To participate to internal cross-functional taskforces, as required by the Clinical Operations Head, as a Medical Affairs Clinical Operations representative and cascade information and decisions as reasonably required.
Key Requirements:
- 10+ years of experience in Clinical Operations mixed with Medical Affairs on national and international programs
- Experience in pharmaceutical drug development - Phase II to Phase III is a plus
- 7+ years of experience in Oncology or Rare Diseases ideally
- At least 5 years of successful experience in line-managing people
- Extensive track-record of interactions with country Medical Affairs Staff is a significant plus,
- Deep knowledge of Good Clinical Practice (GCP) and RWE data regeneration regulations.
- Experience of managing and developing relationships with Service Providers.
- Excellent organisational and management skills
- Excellent verbal and written communication skills
- Full English proficiency
- Computer literacy
- BSc, MSc or PhD
You will be joining the team at a significant period of growth where you'll have the chance to shape/ transform your team into your own with the guidance of the board.
An attractive financial package (Flexible basic salary, Car allowance, 15% bonus, Pension contributions, etc) is on offer for the right candidate.
Please click on the Apply button for more information. Please include a short note outlining why you are interested in the role and why you think you are suitable.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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