Executive Director, Clinical and Medical Affairs
3 weeks ago
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Executive Director, Clinical and Medical Affairs
Welcome to an inspired career.
At Halozyme, we are reinventing the patient experience and building the future of drug delivery. We are passionate about the important work we do, and we need innovative, strategic problem solvers who drive business results by adopting the collective attitude necessary to make our ONE TEAM culture thrive. We embrace open, honest and transparent communications to help us achieve collective win and we constantly strive to do more. That’s why we need you—to help us make a significant impact by taking on increasingly complex challenges, leaping beyond the status quo and advancing our mission.
Join us as an Executive Director, Clinical and Medical Affairs and you’ll be part of a culture that embraces diversity, thinks differently to solve problems, works collaboratively as one team, and delivers meaningful innovations that impact people’s lives.
How you will make an impact
The Executive Director, Clinical and Medical Affairs, reporting to our Chief Medical Officer (CMO), leads all related activities for assigned partner products and proprietary products and will deputize for the CMO as needed. They will provide expertise and strategic insights across multiple settings. As an Executive in this area, they have 5 priorities: the execution of Halozyme sponsored clinical trials, development and execution of the Medical Affairs plan to support Halozyme commercial products, medical leadership of input into ENHANZE partner development programs including support of regulatory agency discussions, medical safety oversight of Halozyme and partner products and participation with business development in discussion to secure new ENHANZE partners and expand the ENHANZE pipeline within current partners.
In this role, you’ll have the opportunity to:
CLINICAL:
- Own the proprietary clinical development function, with current focus Xyosted clinical trial(s)
- Proactively provide scientific and medical expertise and leadership to all aspects of product development for Halozyme products including accountability for the execution of Halozyme sponsored clinical trials within established study milestones.
- Provide medical, drug safety and clinical development expertise to inform ENHANZE partner clinical programs.
- Collaborate with Halozyme Alliance Management and Business Development to identify pipeline products suitable for ENHANZE and play an active role in communicating the value proposition.
- Play a key role in discussions with potential new ENHANZE partners by providing medical and clinical development input to pitch meetings, providing medical insights and solutions to issues raised and promptly following up on action items.
- Proactively build and maintain strong working relationships with medical contacts at our business partners to inform clinical development programs.
- Develop and maintain a deep understanding of the scientific and clinical landscape as it relates to ENHANZE partner products and remain abreast of competitive trends, industry practices, relevant legislation, and customer needs.
- Accountable for maintaining the Investigator Brochures for Halozyme products.
- Safety lead for Halozyme commercial products: medical review of individual cases in the safety database; review safety data from all sources, including weekly literature search outputs, for the detection of safety signals and potential updates to product labels; effective communication on potential and identified safety matters with safety senior management in a timely fashion including the authoring of product safety reports; Responsible for the medical aspects of, and general oversight of Periodic Safety Update Reports and Development Safety Update Reports
- Accountable for medical aspects of health hazard assessments
- Provide clinical input to the Halozyme Business Development group in support of potential acquisitions.
- Represent Halozyme at the FDA, EMEA and other regulatory agencies as required to discuss development pathways for rHuPH20 containing products.
- Represent Halozyme both internally and externally in the scientific community, including at scientific conferences, presentations to current and potential partners and industry leaders.
MEDICAL AFFAIRS:
- Lead the Medical Affairs function.
- Proactively work with the Chief Commercial Officer to develop the Medical Affairs plan for support of Halozyme commercial products,
- Establish a Medical Affairs vision aligned to company priorities and provide oversight to ensure plans are appropriately completed to accomplish business objectives.
- Proactively collaborate with external key opinion leaders, advocacy groups and advisory boards
- Ensure that all Medical Affairs acti
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