Senior Director – Clinical Research&Safety Physician – Ireland

Location: Ireland

Permanent employment contract, based on a hybrid working model

Salary: Depending on the experience and expertise (€145k gross/year)

Benefits: equity, health insurance, pension, life assurance + others

A unique opportunity within a multinational pharmaceutical organisation!

Responsibilities: 

• Overarching medical strategy and medical oversight for multiple assets in the company portfolio, across therapeutic areas and modalities
• Accountability for coordination of physician safety support across the Portfolio
• Provide leadership in early-phase clinical development on multiple exciting programs
• Accountable for the medical and safety leadership for all phases of drug development from candidate selection to proof-of-concept readout
• Authors, reviews and approves key documents, including protocols, risk profiles, informed consent documents, clinical study reports, and disclosure of research results
• Develop understanding of the disease process, patient attributes, concomitant medication usage, and other therapeutic issues in a wide variety of therapeutic areas
• Review and assist in the preparation of regulatory documents (IND, CTA, IMPD, IB, DSURs, etc.) and responses to regulatory questions
• Provide medical leadership in early development study conduct including study design, protocol writing, regulatory documents, CRO interactions, study start up, investigator interactions, data monitoring, health authority interactions, analyses, and study reports
• As a delegate for the Head of Medical and/or the Chief Medical Officer, serve as a single point of accountability for medical safety matters across the portfolio, and the key physician bridge across varied pharmacoviligance processes and stakeholders
• Integrate the totality of early phase data to select an appropriate dose regimen for proof-of-concept studies
• Establish and maintain appropriate collaborations and relationships with external experts, thought leaders, and the general medical community on an international basis
• Effectively respond to queries/comments from Investigators, Regulatory Agencies, Ethical Review Boards, CROs
• Serve as a member of the Protocol Review Committee
• Ensure drug development shared learning amongst colleagues within

Requirements:

• MD or DO with experience in clinical trials management within the pharmaceutical industry – ESSENTIAL
• Experience in drug safety as a drug safety physician / global safety officer is strongly preferred, but other pharmacovigilance experience will be considered
• Minimum 8 years of experience within the pharmaceuticals industry with a focus on patient safety and drug development
• Knowledge and experience in conducting development activities in compliance with all local laws and regulations and ICH guidelines
• Hands-on experience of clinical trial execution as an investigator or sub-investigator
• Experience in the management of medical safety in the context of clinical trials
• Strong leadership and interpersonal skills