Clinical Affairs Manager.

Clinical Affairs Manager

14-month fixed term contract with a view to be longer or permanent

Hybrid working 3 days in the office p/week Mon-Fr

Location: Waterford, Ireland

Salary DOE: 70-100K

24 days of holidays

Ideal start date June

The Manager of Clinical Affairs plays a key role in overseeing, managing, and reporting clinical research to support new product development and regulatory dossier maintenance.

• Leverage expertise in clinical and regulatory affairs to drive the planning, execution, and compliance of both preclinical and clinical studies, ensuring the highest standards of integrity and ethical conduct.
• Utilise their deep understanding of current regulatory environments to optimize the company interactions with US and global regulatory authorities.
• Provide leadership to a team of clinicians, Clinical Research Associates (CRAs) to ensure clinical activities are strategically aligned and effectively support the company’s scientific, regulatory, and commercial objectives.
• Collaborate closely with cross-functional teams to support the commercialization of innovative veterinary therapies and treatments.

Responsibilities

The responsibilities of this role encompass a wide range of strategic and operational activities within the company clinical and regulatory functions; these include (but are not limited to):

• Overseeing the planning, execution, and compliance of clinical studies, aligning with organizational objectives and regulatory requirements.
• Developing and reviewing documentation, including protocols, SOPs, and data capture forms, to ensure compliance with regulatory standards and best practices.
• Managing and monitoring ongoing clinical studies, including data verification, analysis, and interpretation, to ensure data integrity and regulatory compliance throughout the study lifecycle.
• Providing leadership to a team of clinicians (veterinarians), proactively balancing business priorities and regulatory milestones to allocate resources, prioritise workload, and ensure execution of clinical programs in line with company objectives.
• Collaborating closely with cross-functional teams to ensure alignment and synergy between clinical, regulatory, and other functions.
• Ensuring adherence to relevant guidelines, including Good Clinical Practice (GCP) and Good Laboratory Practice (GLP), to uphold the highest standards of research integrity and ethical conduct.
• Maintaining deep and current knowledge of all relevant regulations underpinning new animal drug development in the US and EU.
• Authoring and overseeing the preparation of regulatory submissions for international regulators, including the Center for Veterinary Medicine (CVM) and the Committee for Medicinal Products for Veterinary Use (CVMP).
• Cultivating strategic relationships with key opinion leaders, investigators, and collaborators within the veterinary community, fostering partnerships to advance the clinical research agenda.
• Providing strategic input in cross-functional project planning initiatives, collaborating closely with diverse teams to drive alignment across organizational objectives.
• Planning and tracking project expenditure to aid in efficient resource allocation and budgetary management within the clinical and regulatory affairs function.

Qualifications and Experience

• Honours graduate in a relevant life science discipline; pharmacy, veterinary, MD preferred with a proven track record of achievement in clinical affairs.
• At least 7-10 years of relevant professional experience.
• At least 3-5 years of experience in a people management role, leading and managing teams.
• Proven ability to collaborate effectively with cross functional teams to support delivery of project objectives.
• Extensive experience in clinical research and regulatory affairs within the healthcare or veterinary industry, with a proven track record of successful study execution and regulatory submissions.
• Strong IT skills (MS Office/Excel) and some knowledge of biostatistics.

Other Information Skills, Competencies,

• Possess effective communication and interpersonal skills, with the ability to engage and collaborate with diverse stakeholders at all levels of the organization.
• Demonstrate the flexibility/adaptability necessary to work on multiple different projects at any given time.
• Demonstrate strong problem-solving skills, with a keen eye for detail and a relentless commitment to excellence in all aspects of clinical study execution and regulatory compliance.