Relypsa, Inc. is a late clinical-stage pharmaceutical company leading the discovery and development of novel non-absorbed polymeric drugs for important applications in cardiovascular and renal diseases. Relypsa's lead product candidate is patiromer, a non-absorbed potassium binder, which is being developed for the treatment of hyperkalemia. The company was formed in 2007 and is based in Redwood City, CA. More information is available at www.relypsa.com.
Patiromer (RLY5016) for Oral Suspension is a high capacity non-absorbed oral potassium binder being developed for the management of elevated serum potassium levels. Relypsa completed the Phase 3 clinical program in 2013.
The Medical Director, Medical Affairs, will lead a broad range of medical affairs activities to plan for and support the launch of patiromer. Reporting to the VP, Medical Affairs and working closely with both the Commercial and Clinical Development groups, the Medical Director will play a key role in executing the medical education and scientific development platforms necessary to prepare the market for patiromer. In addition, the Medical Director will work closely with the Commercial group to prepare and finalize marketing and promotional materials, sales training tools and other external communication pieces. The position will lead and participate in various other activities related to the ongoing medical support of patiromer, including the implementation of the patiromer publication plan, supporting thought leader engagement activities, planning and participating in advisory board activities, developing and maintaining relationships with key scientific organizations and participating in the planning of new phase 3b and phase 4 clinical trials as these relate to life cycle management activities. The position may also be involved in developing content and pharmaco-economic projects to support market access and reimbursement. Lastly, the position may be expected to contribute to building the product label and may be required to support components of the clinical portion of the NDA. These are to be full-time, in-house positions.
• Provide Medical Affairs input to the clinical development team regarding commercial aspects of development and to the commercial team regarding the use of scientific and clinical data
• Lead, and provide medical guidance to, the managed care, health economics and outcomes research working groups
• Build evidence-based advocacy by driving and executing the publication plan, presenting at scientific meetings and attending professional seminars and educational programs
• Execute and coordinate the Thought Leader engagement strategy, the patiromer publication plan and regularly update the scientific platform and slide compendia
• Seek medical and scientific input from Thought Leaders by driving and executing the clinical and managed care regional and national advisory board programs
• Review and sign-off (where appropriate) on medical and promotional materials for scientific/medical accuracy, including all promotional pieces, sales training aids, corporate presentations and press releases, publications and drug information letters
• Work closely with Commercial and Clinical Development to design and implement additional clinical studies to either expand the product label or to address any unanswered scientific and medically important questions, as appropriate
• Lead the development and execution of the Investigator Initiated Grant Program
• Provide education and training to Medical Science Liasons and Sales Representatives as needed
• Maintain a high level of clinical and scientific expertise in the disease area(s) by reviewing the literature, attending medical/scientific meetings, and through personal interchanges with consultants, thought leaders, investigators and internal stakeholders
• Ensure compliance with all applicable laws, regulations and regulatory guidelines governing commercial and scientific interactions with healthcare professionals, payers, advocacy and other business partners
• MD or MD/PhD with at least 5 years of medical affairs experience in the pharma/biotech space. Experience supporting a product launch is preferred
• Board certification in Nephrology is highly preferred (clinical experience in academia, clinical, or industry setting)
• Familiarity with GCP/ICH/FDA/OPDP (formerly DDMAC) requirements as well as clinical trial design, biostatistics, product safety, and regulatory affairs preferred
• Strong interpersonal, verbal and written communication skills. Excellent public speaking skills are required with a demonstrated acumen in presenting clinical and pre-clinical data to medical/scientific, business and internal senior management audiences
• Excellent leadership, management and negotiation skills. The ability to work in a fast-paced, highly visible and dynamic environment is critical
• Ability to influence and work effectively across functions and operate in a matrix environment
• Ability to travel 10-15%
• San Francisco Bay Area resident preferred
As an employee of Relypsa, you will actively contribute to the development of potential new products. We provide opportunities for all employees to collaborate, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of
ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs and stock options reflect Relypsa’s high regard for our employees.
NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.
To apply for this position, please send your resume to firstname.lastname@example.org.
Relypsa, Inc. is an EOE