Executive Medical Director, Medical Affairs, Nephrology

Why CorMedix?

CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory diseases. The company is focused on developing its lead product candidate DefenCath™, a novel, antibacterial and antifungal solution designed to prevent costly and life-threatening bloodstream infections associated with the use of central venous catheters in patients undergoing chronic hemodialysis. At CorMedix we are passionate about what we do each and every day! We provide comprehensive benefit and competitive compensation. If you are looking to join a team that puts the patient first and is changing the way that healthcare is delivered – let’s talk!

Company Description:

CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory diseases. Our Company is focused on developing its lead investigational drug product, Defencath™, a novel, antimicrobial and antifungal solution designed to prevent catheter-related bloodstream infections (“CRBSIs) in patients with end-stage renal disease receiving hemodialysis through a central venous catheter. Recently, the Company submitted the New Drug Application (NDA) for Defencath™ to the Food and Drug Administration (FDA). Future research and NDA’s submissions may include indications for similar infectious outcomes in oncology, ICU, and patients receiving total parenteral nutrition (TPN).

Position:

The Executive Medical Director, Medical Affairs, Nephrology will serve in an integral role that will evaluate diseases of interest, act as the lead in communication with clinicians, scientists, regulatory and advocacy leaders and thoughtfully applies their recommendations towards optimizing trial objectives, designs and objectives. This role will require an entrepreneurial mindset to bring creative solutions top challenges. This role will be responsible for critically evaluating available information about diseases of interest to the therapeutic area and the competitive landscape and synthesize information succinctly to support dissemination and incorporation into clinical development programs, asset plans and therapeutic area strategy

Responsibilities include:

· Proactively communicates with clinicians, scientists, regulatory and advocacy leaders and thoughtfully applies their recommendations towards optimizing trial objectives, designs and objectives

· Participates as the Medical contributor for the MLR process

· Works closely and collaboratively to integrate new insights from key stakeholders and refine training and content for field medical colleagues. Significantly contributes to content generation

· May lead one or more clinical study teams in the preparation of clinical study related documents including protocols, charters, statistical summary reports, meeting presentations, publications, and clinical sections of regulatory documents

· Determine appropriate advisory boards experts and lead the team in preparation for meetings

· Participate and occasionally, lead, advisory board meetings. Critically evaluate available information about diseases of interest to the therapeutic area and the competitive landscape and synthesize information succinctly to support dissemination and incorporation into clinical development programs, asset plans and therapeutic area strategy

· Serve as the Medical input to the Global Lead the clinical team and oversee multiple studies for a given program.

· Serve as the Medical input to the Development Team and the Medical Expert for clinical study development team

· Liaise internally with other members of the clinical development to drive overall program strategy and development plans.

· Maintain awareness of internal and external developments (scientific, clinical, competitive, and regulatory) that could impact the development plan, including attendance at major scientific conferences, participation in competitive intelligence activities, and periodic literature review

· Support business development activities, such as due diligence and research collaborations

· May serve as the Translational Science lead for one or more programs

· Critically evaluate available information about diseases of interest to the therapeutic area and the competitive landscape and synthesize information succinctly to support dissemination and incorporation into clinical development programs, asset plans and therapeutic area strategy

· Determine appropriate advisory boards experts as needed for Ad boards

· Working as part of a cross-functional team with colleagues representing, for example, biostatistics, data management, clinical pharmacology, commercial, regulatory and project management

· Publication(s) in peer-reviewed journals

Attributes

· Proven ability to identify and resolve complex problems

· Knowledge of LDO’s and independent HD settings (nephrology specific)

· Entrepreneurial mindset with the ability to bring creative solutions to challenges

Qualifications:

· Doctorate (M.D. or D.O.) degree or PharmD with significant clinical experience in nephrology, particularly ESRD

· Significant industry experience; preferably at least 5 years in CKD/ESRD with familiarity in both inpatient and outpatient settings

· Deep understanding of the biopharma environment and the drug development process

· Experience in the Medical Affairs department as a Medical Director

EEO Statement:

CorMedix is an equal opportunity employer. The Company is committed to providing a safe, respectful, and professional work environment that is free from all forms of unlawful discrimination, harassment (including sexual harassment), and retaliation, and complies with all applicable laws prohibiting such conduct. CorMedix does not discriminate against any individual on the basis of race, religion, color, national origin, ancestry, sex, marital/civil union/domestic partner status, family or parental status, sexual orientation, age, disability, or any other status protected under applicable federal, state, or local law