The HTG Medical Director is a key member of Olezarsen Core Medical Team, reporting to the VP, Cardiometabolic TA Lead -Medical Affairs. The focus of this role is to serve as the Medical Director for Olezarsen, lead core medical team meetings, and represent Medical Affairs on key internal promotional review committees as well as other cross functional meetings. The Director will be a key liaison to other functions as we build towards the future launches. Key activities will include support and execution of product launch plans, lifecycle management, evidence generation, advisory boards, and engagement of KOLs at congresses, and generally helping to support the TA.
Description
Headquartered in Carlsbad, California, and with offices in Boston, Massachusetts, and Dublin, Ireland, Ionis has been at work for more than three decades discovering medical breakthroughs that have redefined life for people with serious diseases. We’re pioneers in RNA-targeted medicines, and our platform continues to revolutionize drug discovery and transform lives for patients with unmet needs. With multiple marketed medicines and a leading pipeline in neurology, cardiology and select areas of high patient needs, we continue to drive innovation in RNA therapies in addition to advancing new approaches in gene editing to provide greater value to patients and are well positioned financially to deliver on our strategic goals.
At Ionis, we pride ourselves on cultivating a challenging, motivating and rewarding environment that fosters innovation and scientific excellence. We know that our success is a direct result of the exceptional talents and dedication of our employees.
With an unprecedented opportunity to change the course of human health, we look to add diverse individuals, skill sets and perspectives to our exceptional team. We continue to invest time, money and energy into making our onsite, hybrid and remote work environments a place where solid and lasting relationships are built and where our culture and employees can thrive.
We’re building on our rich history, and we believe our greatest achievements are ahead of us. If you’re passionate about the opportunity to have meaningful impact on patients in need, we invite you to apply and join us. Experience and contribute to our unique culture while you develop and expand your career!
SUMMARY:
- Medical Director (levelling may be at the Director or Associate Director level based on experience)
- Location: Headquartered in Carlsbad, CA or satellite office in Boston, MA; person may be remote or in-person
- Reports to: VP, Cardiometabolic TA Lead -Medical Affairs
In 2020, Ionis leadership made the bold decision to shift the company to directly serving patients by launching our products independently as a fully integrated biotechnology company. In the course of just a few years, we’ve built a wholly owned, rich, late stage pipeline of potentially life-changing RNA-targeted medicines for people in critical need of significant advances, particularly in our focus areas of neurology and cardiology.
The company is currently building up its medical and commercial organizations to allow for commercialization of its wholly owned assets.
TRYNGOLZA (Olezarsen) is an APOC-III-directed antisense oligonucleotide (ASO) indicated as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS). Olezarsen is under investigation for severe hypertriglyceridemia (sHTG).
The HTG Medical Director is a key member of Olezarsen Core Medical Team, reporting to the VP, Cardiometabolic TA Lead -Medical Affairs. The focus of this role is to serve as the Medical Director for Olezarsen, lead core medical team meetings, and represent Medical Affairs on key internal promotional review committees as well as other cross functional meetings. The Director will be a key liaison to other functions as we build towards the future launches. Key activities will include support and execution of product launch plans, lifecycle management, evidence generation, advisory boards, and engagement of KOLs at congresses, and generally helping to support the TA. The candidate will have a solid clinical, scientific, and pharmaceutical industry background as well as a deep understanding of Medical Affairs and Marketing/Commercial principles, guidelines, and industry standards.
RESPONSIBILITIES:
- Partner with the commercial and clinical teams to support launch planning and medical strategy and tactics.
- Serve as the medical FCS, sHTG, and olezarsen expert and represent Medical on Promotional review committee teams.
- Review and share input on scientific narratives as additional product data becomes available.
- Review and share input on evidence generation plans and provide input to ongoing studies, as appropriate.
- Engage with key opinion leaders and participate in relevant congresses.
- Participate and share input to enable the development and execution of the medical plan, and support the TA medical lead attain endorsement for the plan by senior leadership at Ionis.
- Help with the strategy and creation of congress symposia
- Work with the Med Affairs TA lead, clinical and commercial to support advisory board planning and execution
- Maintain strong scientific knowledge of the dyslipidemia market from both a scientific perspective as well as from the perspective of the current and future competitive landscape.
- Help with vendor management as appropriate for the various projects to support the brand.
- Provide medical insights and guidance for product strategies, medical review, competitive intelligence, and health outcomes.
- Work closely with Medical Affairs colleagues to ensure appropriate budget setting, resource allocation, and expense monitoring.
- Ensure compliance of all Medical Affairs activities with all local regulatory and legal requirements
REQUIREMENTS:
The successful candidate must be an energetic individual with strong interpersonal skills. The person who will be successful in this role will have the ability to work with a diverse set of individuals across different functions and organizations. The person will be expected to add value to the different teams by bringing forward experience in medical affairs complemented by an understanding of the complexity of FCS, sHTG, and other cardiometabolic markets, drug development, commercialization, launch, and lifecycle management. The person in this role must be a self-motivated, approachable, articulate team player who has a high level of emotional intelligence, integrity, and a core value system consistent with the Ionis culture and core principles.
- Medical degree or doctorate degree desired, PharmD / PhD required
- Experience in rare disease, cardiology, or metabolic disease highly desirable
- Experience developing and executing medical affairs strategies and plans
- Associate Director: Established 5+ year track record in the pharmaceutical industry in a variety of Medical Affairs roles
- Director: Established 8+ year track record in the pharmaceutical industry in a variety of Medical Affairs roles
- Experience working in the US market, and global experience a plus
- Experience supporting product launches
- Strong organizational skills, delivering on commitments in a timely manner, while maintaining a strong customer focus
- Entrepreneurial thinking, self-starter with positive can-do attitude
- Demonstrated ability to successfully communicate scientific results and effectively respond to data queries from customers and/or consultants
- Ability to handle ambiguity and uncertainty, make appropriate prioritization decisions aligned with strategy, and drive projects to completion
- If remote, up to 30% travel to HQ and Congresses
ADDITIONAL BENEFITS TO THIS OPPORTUNITY
- Opportunity to work within antisense technology in the company that created new biotechnology industry sector focused on RNA-targeted therapeutics
- Ionis is at an incredible time of growth – highly visible and demanding role as the company builds its commercial capabilities accelerating the next phase of growth; opportunity to join a very smart team that is key to the future of the business
- Ionis is a small and innovation-focused organization with a prolonged cycle of productivity and success, well positioned for accelerated growth and to build commercial capabilities
- Very entrepreneurial in nature, with a good balance of being small and nimble; well-capitalized to invest in core capabilities and beyond
- Close partner exposure to senior executives offering a lot of experience with launches and partnering with medical affairs