SENIOR DIRECTOR, CLINICAL AFFAIRS
BRIEF COMPANY PROFILE
Our client is an innovative MedTech company operating on a global scale and headquartered in the Øresund region. The company has a strong track-record of developing groundbreaking new products and setting new industry standards.
With the objective and ambition to further strengthen the Clinical Affairs function and capabilities at the company, the Senior Director will be responsible for developing and driving the organization’s global clinical affairs strategy – while working in close collaboration with other key functions and stakeholders including Global Innovation and Marketing.
Further, this role will ensure superior organizational readiness to support the company’s growing product portfolio with the necessary clinical documentation and support these efforts by providing a strategic understanding of medical device development in the global regulatory arena.
Additionally, and with the direct leadership of 30+ FTE’s in a growing team of diverse profiles, the position will be overall responsible for exerting effective strategic leadership and management of the team.
Consequently, the position calls for a skilled Clinical Affairs profile with vast experience in leading and driving teams and clinical affairs strategies – ideally in the Medical Device/IVD area. Additionally, experience in an international environment is preferred, while strong communication-, stakeholder management- and leadership skills are equally favored with the ideal candidate.
Senior Director, Clinical Affairs
Chief Development Officer
30-40 days per year
Responsibilities & Tasks:
Developing global clinical affairs strategies, in close collaboration with regulatory affairs, marketing, research & development, reimbursement, and outcomes planning, and obtaining approvals by the most effective method possible.
Ensuring organizational readiness for submitting applications for product approval by regional regulatory bodies (EU, FDA, PMDA a.o.).
Developing and executing the Clinical Affairs Strategy to generate data for both marketing and regulatory purposes.
Enrolling and managing KOL / physician-clinician engagement and leading the management of all Clinical Affairs investments and required support.
Executing studies in the US, EU and Asia in full compliance with all applicable GCP requirements, regulations, and standards.
Collaborating with Regulatory Affairs and R&D to strategize best effective approaches to clinical study designs and execution to support regulatory approval.
Approving contracts and budgets with sites, CRO’s and vendors.
Taking responsibility for data collection, analysis, and presentation to company management.
Managing the preparation of data for publication, white papers, presentations, etc. .
Preparing and approving of protocols for projects and reviewing final study conduct documents such as study manuals, study plans, study tools, etc..
Developing staffing plans according to needs.
Initiating investigator and coordinator meetings.
Participating in Risk management and R&D DRs representing clinical affairs.
Providing oversight of individual clinical trials to ensure full compliance with GCP and that safety concerns and/or adverse events are identified and appropriate responses to such concerns are executed.
Providing advice to the customer complaint reportability team of adverse events and other clinical trial issues to regulatory agencies.
Determining membership criteria and identifying potential members for clinical events committees and data monitoring committees.
Reviewing and approving trigger plans for CEC and DMC.
Reviewing and approving Clinical Risk-Benefit Analyses.
Reviewing and approving study corrective action plans.
Preparing for and participating in internal/external study-related audits.
Developing and maintaining Clinical Investigation,conduct infrastructure – drafting and/or reviewing of SOPs, DOPs, and Work Instructions.
Demonstrating thorough knowledge of and coaching others in the appropriate application of clinical research conduct, laws, regulations, standards, and compliance with applicable SOPs and policies.
Maintaining familiarity with global medical device regulations and national certification schemes.
Participating in requested meetings and Trade Shows (demo equipment on the show floor, participate in wet lab events), etc.
Participating in professional organizations or conferences to keep abreast of developments in the relevant fields of medical devices.
Key success criteria:
• Achieving successful approval of pipeline products in all regions.
• Ensuring a strong collaboration with relevant internal stakeholders i.e. Marketing, Finance, Regulatory Affairs a.o..
• Successfully driving Clinical Affairs strategy processes in alignment with the corporate strategy.
Academic degree within natural sciences or healthcare at a Master’s level or higher.
English – fluent (verbally and written).
Ideal experience and competencies:
• 7+ years of experience with Clinical Affairs from a Medical Device, IVD or similar environment.
• Experience with working in complex Matrix
• Demonstrated strategic understanding of medical
device development in the global regulatory arena, and relevant, recent knowledge within international regulatory standards.
• Positive personality with highly developed social skills, a constructive team approach and the ability to manage a diverse and international group.
• Demonstrated ability to reach an in-depth, holistic understanding of the business objectives, strategies, and priorities of a company combined with experience with planning and governance structures necessary to deliver on these priorities.
• Innovative mind-set and a natural driver of change.
• Strong communicator, as there will be a high
degree of interaction with both internal and
• Well-versed in Program/Project level planning,
status reporting and risk management.
• Proven experience of navigating smoothly within
change management frameworks.
• Proficiency in all Microsoft Office Applications.
• Demonstrated superior level of organizational
intelligence and ability to operate effectively in a complex environment, under pressure and to tight deadlines with discretion and political sensitivity.
• Excellent relationship-building skills.
Defines a clear vision. Looks beyond the immediate difficulties and focuses on the far-reaching consequences; sees things in a broad perspective; takes tendencies in the environment into account when planning and developing strategies.
Is able to synthesize complex situations, interpret data, identify key business issues and opportunities, create strategies, and drive results internally and externally. Navigates well within complexity and divides problems into relevant parts, while sensitively integrating the analytical output into a given context. Is able to address the complex interrelationships among factors that influence solutions to business issues in order to articulate key business strategies.
Is pragmatic and able to identify, establish and maintain relations with stakeholders at all levels – internally as well as externally – and makes people feel at ease. Achieves agreement by dealing with disagreements and potential conflicts within a diplomatic manner. Develops and maintains networks.
Works systematically and structured regarding problem-solving, organizes work and effort, and is methodical in her/his performance.
Superior executive communication skills
Possesses exceptional executive-level oral and written communication skills and is able to formulate and deliver insights around complex business problems in a thoughtful and persuasive manner. Possesses credibility and integrity to be an effective ambassador for the company.
Makes sure employees/co-workers have a clear understanding of the direction of the tasks; takes action; organizes resources and direct others toward successful execution of the tasks; drives projects forward to reach pivotal objectives; makes things happen and follows through.
Results and goal orientation
Establishes visible and achievable goals for the role. Focuses on action, activities and results and is able to continue working with a specific problem, viewpoint or action plan until a result has been achieved or it is determined that an alternative approach is needed.
Collaborates and works well with others with a view to obtain the team's objectives by sharing information and supporting others. Fosters an environment of open communication and knowledge sharing. Possesses a love for team-based work within a high intensity environment.
Is highly dynamic, inspires others and encourages the achievement of set goals by promoting a sense of energy and purpose. Provides inspiration for a positive work attitude and prompts a strong wish to succeed in the team.