Head of EU Clinical Operations - Zug, Switzerland

Job content

Arena Pharmaceuticals is driven to deliver novel, transformational medicines with optimized pharmacology and pharmacokinetics to patients globally. Arena’s proprietary pipeline includes multiple potentially first or best-in-class assets with broad clinical utility.

The Head of Clinical Operations – Europe,will be a Zug-based Senior Director level role, pivotal to the managerial leadership of the EU regional clinical operations team. This position will report into the Vice President, Clinical Operations. The key accountabilities for this role will be in the successful execution of the clinical development plans in the EU region, building and line management of the European Clinical Operations team, and budget responsibility for the EU/UK team.

Successful Execution Of The Clinical Development Plans

This key strategic leadership role will provide regional oversight to clinical trial operations within a variety of therapeutic areas (i.e., Gastroenterology, Dermatology and Cardiovascular). The candidate will have an opportunity to define and execute on clinical operation strategy and will have accountability for the quality of trial operations, data integrity, as well as site activation and recruitment timelines for the EU / UK regions.

Line Management

This role will have the opportunity to recruit, build, develop and lead a clinical operations team, as well as contribute to the transformation of Arena’s clinical development organization. This role will also need to assess program resourcing needs, and provide the mentorship of direct reports, career development, and performance reviews.

Budget

This role will be accountable for managing the EU team annual and long term forecasting/ budget for items like, travel, conference registration, training, etc.

The ideal candidate will have extensive experience leading global phase II-III studies, managing external CRO partners as well as supporting inspection readiness activities. NDA/EMA/PMDA submission experience a plus. The candidate should have experience managing a globally diverse team.

What You Will Dive Into

• Lead and mentor the clinical operations team in the efficient and high-quality execution of studies while ensuring compliance with GCP, SOPs and applicable regulations
• Manage resources, hiring, onboarding, proactively manage resource distribution and the assessment of future program needs
• Mentor and oversee staff, direct personnel activities, provide guidance for professional development of staff, address talent gaps and development opportunities
• Review and provide input on trial designs to ensure clinical strategies incorporate operational input.
• Review and provide input into Clinical Operations SOPs and process
• Mentor team to perform risk assessment, proactively identify risks and mitigations and implement corrective action plans
• Drive team and regional CRO for expedited regional country and ethic submissions, query review, and response turnaround timelines
• Oversee the performance and review of regional feasibility assessments to ensure the selection of appropriate sites in region
• Accountable for strategic site activation and ensuring fast start up activities in EU and APAC regions
• Coordinate with appropriate cross-functional departments to facilitate negotiation/ issue resolution for clinical trial related issues
• Build strategic partnerships with PIs, Coordinators and work alongside Clinical Development to facilitate and support the KOL relationship in region
• Responsibility for management of external CROs and vendors in region
  

What We Expect

• Minimum of Bachelor’s degree, with advanced degree preferred
• 20+ years of direct clinical operations trial experience facilitating the running of multiple, global Phase II and III trials
• Demonstrated people leadership of clinical operations across all phases of clinical development, protocol development, study start-up, study maintenance, database lock, results analysis and reporting. NDA/EMA/PMDA submission experience a plus.
• Expert knowledge of the drug development process, Health Authority regulations and ICH technical aspects of clinical study conduct
• Leads through influence, interpersonal versatility; ability to establish relationships with internal and external personnel. The successful candidate will likely have had previous in-depth sponsor side oversight from a similarly scaled Biotech
• An entrepreneurial attitude required to act as a change agent through inspirational leadership aligning activities to business and corporate goals
• Driven to speak effectively and communicate directly with all levels of personnel in a positive and collaborative manner
• Ability to interpret and/or develop a variety of instructions furnished in written, oral, diagram, or schedule form
• Proven Relationship building expertise with diverse groupings from Patient Advocacy, International MSL / KOL with strong follow-up and organizational skills
• Ability to identify situations which require intervention for resolution
• Must be able to maintain confidentiality
  

What We Offer

• Ability to work Remotely within Switzerland combined with Zug office presence
• To be a part a growing company and fantastic team passionate about developing novel drug therapies to improve people’s lives
• Opportunities to learn and contribute creative solutions
• Multi-cultural work environment
• Competitive compensation package (incl. long term incentives)
• Summer and Winter break provided by the company
• Company celebrations
• Public holidays of canton Zug