2 Layers

Bringing inhaled sedation to intensive care.

Karriär

DIRECTOR OF CLINICAL DEVELOPMENT & OPERATIONS

STOCKHOLM, SWEDEN

We are searching for a Director of Clinical Development & Operations to provide leadership, and strategic and operational oversight of all clinical operations, reporting to the Chief Medical Officer.

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The ideal candidate is a passionate, caring, self-starter who brings knowledge, enthusiasm, integrity, focus and perspective to the Clinical Operations team and actionable insights to Clinical Development. The Director will be accountable for meeting milestones and company goals while keeping costs in control. He/she will oversee the timeline, budget, quality, resourcing, and risk management. In addition, the Director will supervise the activities of Clinical Research Organizations (CROs) and other vendors in conducting and managing clinical trials.

Responsibilities
(duties are not limited to the below and may evolve over time depending on business needs and individual expertise)

  • Responsible for contributing to and precise execution of the clinical development strategy and study protocols, including the sponsor oversight and budget of CRO-managed clinical trials and early development clinical operations at the company.
  • Ensure high standards for compliance with company SOPs, ICH-GCP guidelines, governing regulations and patient safety standards.
  • Accountable for establishing and maintaining inspection readiness across multiple programs.
  • Lead and mentor all members of the clinical operations group to ensure that successful internal training is carried out and that project, organisation and individual goals are met.
  • Lead by example; provide advisory support to colleagues and foster collaborative decision-making and achievement of corporate goals.
  • Collaborate with other functions to establish new initiatives and ensure continuous and smooth operations of ongoing activities.
  • Contribute to business development activities by providing clinical trial expertise and strategic, operational considerations.
  • Communicate regularly and effectively with senior leaders across the R&D organisation.


Education/Experience

  • University degree in Life/Health Sciences.
  • At least 5 years of experience in clinical development/operations in the pharma and/or medical device industry, preferably knowledge of both.
  • Experience from working at a headquarter (preferred) and in a matrix environment with other functional groups (e.g. Regulatory, Med. Affairs, Commercial) where consensus across multiple opinions and good working relationships are important; experience in managing external groups in these areas.
  • Experience from a managing position.
  • Proficient at creating and communicating a clear vision among internal and external team members, effectively aligning resources and activities to achieve functional area and/or organisation goals.
  • Strong communication and teambuilding skills.
  • Excellent verbal and written communication skills in English.
  • Experience in planning, organisation, and project management.


What we offer

  • Full-time employment (40 hours/week), starting as soon as possible, considering any notice period.
  • Competitive salary, insurance, pension scheme and wellness allowance.
  • New modern premises at the global headquarter in Danderyd.


Are you interested?

To apply for this position, please submit your application and CV. Please note that selection and interviews take place on an ongoing basis.

If you have any questions, please get in touch with us at recruiting@sedanamedical.com