United Spinal Association Jobs

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. Thats why we need youto 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 youll be part of a culture that embraces diversity, thinks differently to solve problems, works collaboratively as one team, and delivers meaningful innovations that impact peoples 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, youll 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 acquisit ons.
• 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 activities are conducted in accordance with applicable laws, rules and regulations.
• Proactively provide medical input to the development of promotional materials and medical information letters; serve on the medical legal review committee.
• Provide medial support to call center enquiries when advanced.
• Lead and oversee the Halozyme Scientific Publication plan, providing medical input to publication and congress planning and congress attendance.

To succeed in this role, youll need:

• M.D. degree required, preferably with post-graduate, broad-based specialty training with at least 10 years of applicable industry experience in biotechnology or pharmaceutical, preferably in a fast-paced, dynamic environment (an equivalent combination of experience and education may be considered)
• Minimum of 8 years of clinical practice experience strongly preferred.
• Extensive external networks within at least one relevant therapeutic area necessary
• Excellent understanding of FDA and EMA regulations, Good Clinical Practice, ICH guidelines, and clinical drug development
• Strong eye for business
• Strategic problem solver and executive presence
• Experience in regulatory submissions to the FDA and other regulatory agencies, including interaction with these agencies.
• Solid leadership skills with a history of leading others to success and a reputation for running high performance teams.
• Strong communication, negotiation and influencing skills to build both internal and external relationships, including the ability to assist in building, maintaining and leading external partnerships.
• Proven ability to think creatively and be an idea generator, and to capitalize on business opportunities by developing well-thought out, innovative, effective strategies and initiatives.
• Proven ability to operate effectively within an entrepreneurial and science-driven company environment.

In return, we offer you:

• Hybrid work flexibility-minimum of 3 days weekly in the office
• Full and comprehensive benefit program, including an Employee Stock Purchase Program and 401(k) matching.
• Opportunities to grow in a culture that prioritizes learning, development and progression through in-house programs and tuition reimbursement.
• A collaborative, innovative team that works as one to amplify your impacton your career, the work you do and patients lives.

Halozyme, Inc. is an Equal Employment Opportunity (EEO) employer. It is the policy of the Company to provide equal employment oppo