Ardelyx was 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), as well as early-stage pipeline candidates.
Purpose of the role:
The Medical/Scientific Director (MSD) is responsible for overseeing all activities related to Medical Review for Gastroenterology and Nephrology. The MSD is accountable for ensuring that all scientific content (e.g., promotional materials, medical field materials, medical information materials, training materials/programs, and other material) is of the highest scientific quality and is compliant with all relevant policies, procedures, and regulations, for the assigned therapeutic areas. In this role, 60-70% of time will be focused on medical review of promotional and medical documents. Additionally, the MSD will provide strategic support and field support for MSL activities, in both therapeutic areas. This role will report to the VP, Medical Affairs.
Position Responsibilities:
- Ensure timely and comprehensive review of promotional and medical PRC submissions.
- Assure all medical content meets established scientific standards and is compliant with all applicable policies and regulations.
- Participate in all aspects of medical review, providing expertise and guidance as lead Medical Reviewer on PRCs.
- Ensure appropriate early medical guidance and scientific direction is provided on promotional strategies and messaging within assigned therapeutic areas.
- Proactively lead effective coordination and alignment between medical review and other MA functions.
- Partner with MA staff in other functions to drive consistent interpretation of scientific data and establish a consistent, unified medical voice/position across MA.
- Stay abreast of and lead discussions as a functional expert on newly available clinical data and promotional content within the assigned therapeutic area, as well as regulatory milestones, actions, and guidance relevant to medical review activities.
- Lead new projects/initiatives within MA and across functions as assigned.
Position Requirements:
- Advanced degree: PhD, PharmD, or MD preferred.
- Previous PRC and/or MRC review experience required.
- 7-10+ years of relevant experience in a pharmaceutical or biotechnology company.
- Ability to collaboratively work in a multidisciplinary team.
- Excellent communication skills.
- Demonstrated patient-centered approach.
- Strong knowledge of pharmaceutical and promotional compliance guidelines, laws, industry standard practice and applicable regulations.
- Up to 10% travel, including overnight and occasional weekend travel.
- Attendance at periodic national internal and external meetings and medical congresses.
Location:
The anticipated annualized base pay range for this full-time position is $216,487.80 - $264,596.20. 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 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.
