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Head of Clinical Evidence, Opella

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Sanofi

26d ago

  • Job
    Full-time
    Expert Level
  • Research & Development
    Healthcare
  • Frankfurt

AI generated summary

  • You must have an advanced degree, 10+ years in global clinical studies, regulatory expertise, leadership skills, and strategic thinking. Fluency in English and familiarity with digital tools are essential.
  • You will lead clinical operations, develop programs, manage resources, ensure compliance, oversee study execution, foster team growth, and collaborate cross-functionally to support strategic initiatives.

Requirements

  • Higher level degree (M.D., PhD, MBA) is mandatory.
  • Additional certifications in clinical research, regulatory affairs, or health economics are a plus.
  • Previous experience leading a global clinical organization including management of large multi-country budgets.
  • Over 10 years’ experience in managing global clinical studies, medical scientific affairs, R&D functions and/or regulatory experience in pharmaceutical industry.
  • A minimum of 10 years of experience in managing global clinical studies including oversight of CROs and study specific vendors.
  • Experience in a Consumer healthcare product and strategic development environment.
  • Proficient in International Regulations, Guidelines, Good Practices pertaining to the pharmaceutical industry standard and practices for clinical / bioequivalence studies conduct.
  • Experience in regulatory interactions (FDA, EMA, PMDA, etc.) regarding clinical evidence requirements.
  • Innovation & Adaptability: Ability to explore emerging data sources, digital tools, and AI-driven analytics for evidence generation.
  • Strategic Thinking: Ability to align evidence generation plans with regulatory & commercial needs.
  • Scientific Expertise: Deep knowledge of clinical research methodologies, biostatistics.
  • Regulatory & Compliance Knowledge: Understanding of global regulatory requirements for clinical evidence and post-market surveillance.
  • Leadership & Communication: Excellent ability to lead multidisciplinary teams, influence decision-making, and present complex data effectively to diverse audiences.
  • Fluent spoken and written English.
  • An Additional language is desirable.

Responsibilities

  • Set the strategic direction of Clinical Operations & allocate resources to prioritized opportunities
  • Develop clinical programs fit-for-Consumer Healthcare, in an agile and innovative manner
  • Lead and develop a high performing team by developing capabilities and competencies, and ensure a pipeline of talents
  • Foster an environment/culture of learning and sharing of best practice within the team
  • Be an active member of the Global Medical & PV Leadership Team
  • Provide leadership across all clinical phases which includes study start up, budgeting, CRO/vendor selection, contracting and training, study closure and study archiving, ensuring compliance with all applicable external regulations (ICH-GCP) and internal quality standards (SOPs / QDs).
  • Set the strategic direction and capability of the team, aligning with global and regional needs in-line with the Science Hub and overall Opella Strategy
  • Support claims through data generation including conventional clinical studies and emerging digital evidence generation capabilities.
  • Oversee operational plans, tactical execution of studies, protocol preparation and clinical study report writing
  • Develop specialized capabilities in emerging areas of medical operations – including integration of Digital, Diversity and Sustainability into clinical strategies
  • Ensure compliance of key activities to external regulations (ICH-GCP) industry and company quality standards (SOPs / QDs).
  • Ensure the set up and monitoring of KPI for clinical operations, identify lead and lag measures with the teams.
  • Develop cross-functional collaboration within and amongst research sites, leveraging best practices and learnings to ensure high quality service to customers and patients
  • Ensure timely support of authority inspections with regards to quality and regulations.
  • Collaborate with Medical, Pharmacovigilance, Regulatory, R&D and Quality team members to ensure strategic fit and compliance of department/study activities with authority (e.g. FDA, EMA) and other regulations, guidelines, and principles of ICH-GCP and company SOPs.

FAQs

What is the main purpose of the Head of Clinical Evidence role at Opella?

The main purpose of the Head of Clinical Evidence role at Opella is to lead the strategy and execution of clinical evidence generation to support regulatory approvals, innovations, and the commercial success of Opella products by designing and overseeing clinical studies that demonstrate product value and safety.

What qualifications are required for this position?

Candidates are required to have a higher-level degree (M.D., PhD, or MBA) as a mandatory qualification, with additional certifications in clinical research, regulatory affairs, or health economics being a plus.

What type of experience is necessary for this role?

The ideal candidate should have previous experience leading a global clinical organization, managing large multi-country budgets, over 10 years of experience in managing global clinical studies, and experience in consumer healthcare products and strategic development.

What skills are essential for success in the Head of Clinical Evidence position?

Essential skills include innovation and adaptability, strategic thinking, scientific expertise, regulatory and compliance knowledge, leadership and communication skills, and fluency in English, with an additional language being desirable.

Will the Head of Clinical Evidence lead a team?

Yes, the Head of Clinical Evidence will be responsible for leading a team of experts in Clinical Operations, Statistics, and study design to foster a high-performing team environment.

What are key responsibilities in this role?

Key responsibilities include setting the strategic direction of Clinical Operations, developing clinical programs, overseeing operational plans, ensuring compliance with external regulations, and developing cross-functional collaborations.

Are there opportunities for professional development in this position?

Yes, the role offers opportunities for professional development through fostering an environment of learning and sharing best practices within the team.

How does this role support the mission of Opella?

This role supports Opella's mission by ensuring that clinical evidence generation aligns with the goal of helping consumers take their health into their hands through effective and safe products.

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Sanofi

Science & Healthcare
Industry
10,001+
Employees
2004
Founded Year

Mission & Purpose

We are Sanofi, an innovative global healthcare company. We chase the miracles of science to improve people’s lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.