Senior Director, Global Clinical Development

Company Description

Sirtex Medical is a global leader in healthcare, with offices in the U.S., Australia, Germany, and Singapore, dedicated to improving patient outcomes.
 

Our mission is to be at the forefront of minimally invasive cancer and embolization therapies. By partnering with physicians, we aim to provide innovative products that enhance patient outcomes and simplify treatments. Achieving this ambitious goal requires passionate and talented individuals who are committed to making a difference. Our flagship product, SIR-Spheres® Y-90 resin microspheres, is a targeted radiation therapy for liver cancer. To date, we have delivered over >150K doses across 50+ countries, significantly impacting patients' lives worldwide. Our success is fueled by our dedication to serving the medical community, maintaining professionalism, fostering a collaborative work culture, nurturing an entrepreneurial spirit, and continuously pursuing innovation and improvement.
 

At Sirtex, we are committed to creating a great workplace. We offer a range of benefits, programs, and services to support our employees, ensuring they have opportunities to contribute to our success and advance their careers. Join our inclusive community, where you can collaborate with talented colleagues, bring your ideas to life, and advance your career, all while delivering innovative healthcare solutions to patients.

Job Description

The Senior Director of Clinical Affairs will provide leadership and broad scientific and medical input to activities that span across the scope of clinical development, including leading strategic planning and execution of clinical development plans, providing support of regulatory submissions, contributing to/leading the development and execution of the medical/clinical affairs plan. The candidate should be able to work in a cross functional manner to bring a broad range of input into partnerships with internal stakeholders but be able to work with key opinion leaders/PI's/and leading clinical sites for external input into the program's strategy. The individual in the role will also be responsible for establishing, implementing and maintaining departmental policies, procedures, and strategies to ensure that trials are performed in accordance with Good Clinical Practices (GCP) and ISO 14155.

PRIMARY RESPONSIBILITIES:

• Collaborate with Medical Directors, MSLs, Research and Development (R&D) the Heads of Regional Sales and Marketing (S&M), Global Head of Marketing, Global Head of Quality and Regulatory and Health Economics to execute clinical programs. This position will report to the SVP of Medical & Clinical Affairs.
• Ensure appropriate scientific rigor in the design, conduct, validity and interpretation of clinical trial to support regulatory applications or business/marketing objectives.
• Identify significant issues that may impact overall project plans and initiate contingency plans as appropriate.
• Deliver clinical/scientific input during the development and execution of clinical trials including protocol development through the review and interpretation of trial results and finalization of the clinical study report
• Provide medical expertise and support to externally facing groups/stakeholders, including the field medical team, medical information, the commercial organization, expert advisors and key opinion leaders, payers and commercial advisors, and professional organizations
• Oversee implementation of clinical trials globally by approving execution plans in agreement with the SVP of Medical & Clinical Affairs.
• Manage and maintains metrics across clinical trials (e.g. patient recruitment to study goals, expenditure and cash flow to budget, administrative compliance and safety reporting. Ensures that ongoing data review is performed for studies, as appropriate and that clinical trials will deliver the highest quality data to maximize likelihood of successful trial outcome
• Approve final investigator site selection for clinical trials
• Coordinate all relevant Clinical Operations activities/documents related to regulatory and ethics submissions
• Manage the implementation of the Clinical Operations by providing direction and oversight to the Clinical Research Managers and Medical Manager/Advisor in the region
• Develop and manages the Clinical Affairs budget within stated financial goals
• Approve CRO and other vendors as appropriate
• Participate in the preparation of periodic regulatory agency reports
• Direct line management and mentorship to clinical research personnel
• Understand the legal and compliance environment and drive collaboration with the Legal and Compliance team
• Collaborate with key functional areas to meet corporate goals and objectives
• Work with other Clinical Operations staff globally to ens