Description
Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA (tenapanor) and XPHOZAH (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been approved in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada.
Position Summary:
The Vice President, Medical Affairs will set all Medical Affairs strategies and is accountable for management of all Medical Affairs initiatives in support of all Development and Commercial programs. This leader will be responsible for development and strategic oversight of the company's post-approval activities, building robust Key Opinion Leader partnerships, building and managing a high functioning Medical Affairs team, and Medical Science Liaisons. The ideal candidate will have extensive experience in Medical Affairs, pharma/biotech launches, and KOL development. The role reports to the Chief Medical Officer.
Responsibilities:
- Lead Medical Affairs strategic input and direction for marketed products; provide critical strategic and day-to-day management support in the area of Medical Affairs management. Provide strategic input into the development plans for drugs to support Commercial needs when marketed
- Drive creation and oversee execution of the following strategic plans: Publication Plan, KOL/Advisory Board Plan, Investigator-Initiated Research Plan, Real World Evidence Generation Plan, and Continuing Medical Education/Grant Plan to optimize the product profile to build product awareness and gain strategic insights for marketing and development strategy
- Grow and manage a high-functioning Medical Affairs organization with a focus on staff development and appropriate succession planning. Ensure that company practices are compliant with relevant drug regulations
- Provide Medical Affairs leadership to the MSL teams and overall accountability for the development and management of relationships with Key Opinion Leaders (KOLs)
- Serve as a senior representative to KOLs, working in collaboration with Senior Company colleagues similarly involved providing strong medical and scientific presence
- Provide strategic leadership and collaboration for Disease strategy plans, abstracts, posters, slides, manuscripts, educational materials, Investigator-Initiated study protocols, Advisory board meeting objectives, Medical information letters, Commercial Brand plans, scientific educational grant requests and patient advocacy grant requests
- Serve as a senior representative of Medical Affairs to interact with key internal stakeholders: Commercial, Business Development, Market Access, Clinical Operations, Clinical Sciences, Regulatory, and Program and Portfolio Leadership
- Provide medical leadership and support to the Commercial Team to assist in the development and execution of compliant commercial activities; provide Medical Affairs strategic input for the elaboration of the brand plan(s); ensure execution of the Medical Affairs Strategy in line with the Brand Strategy and the execution of compliant Commercial activities
- Utilize medical/scientific, technical, and managerial experience to support research programs, clinical development programs and licensed product maintenance, including developing the strategy for advisory Board and KOL meetings
Qualifications:
- PhD, PharmD, MD or equivalent with 15+ years in biotech/pharma industry in Corporate Medical Affairs or equivalent experience
- 10+ years of managing and leading post commercial clinical and medical teams
- Previous experience managing a medical affairs function and/or demonstrated success implementing Medical Affairs program(s) at a biotech/small pharma strongly preferred
- Product pre-launch/successful launch experience required
- Demonstrated knowledge of FDA requirements, industry compliance, ISS design and strategies, commercial and publication strategy and medical information processes
- Working knowledge of current legal and promotional regulatory requirements, demonstrated appreciation of the global compliance landscape
- Ability to interact and communication with a high degree of professionalism and scientific credibility to the Thought Leader community
- Ability to establish strong working relationships with a diverse range of internal and external stakeholders to ensure achievement of corporate objectives
- Possess strong and dynamic leadership skills. Successful and superior influencing skills across all levels of the organization and external collaborators
- Ability to travel up to 25%
The anticipated annualized base pay range for this full-time position is $328,000-$400,000. Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers. Actual base pay will be determined based on a variety of factors, including years of relevant experience, training, qualifications, and internal equity. The compensation package may also include an annual bonus target and equity awards, subject to eligibility and other requirements.
Ardelyx also offers a robust benefits package to employees, including a 401(k) plan with generous employer match, 12 weeks of paid parental leave, up to 12 weeks of living organ and bone marrow leave, equity incentive plans, health plans (medical, prescription drug, dental, and vision),life insurance and disability, flexible time off, annual Winter Holiday shut down, and at least 11 paid holidays.
Ardelyx is an equal opportunity employer.
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Ardelyx
life insurance, parental leave, paid holidays, flex time, 401(k)
Jun 04, 2025