We're looking for a candidate to fill this position in an
Develops medical affairs strategy and plans with
cross-functional teams working closely with key stakeholders
including the Heads of Regulatory Affairs, Clinical Operations,
CMC, and R&D stakeholders.
Works with future CMO to shape direction of overall medical
Ensures Medical Affairs provides medical/scientific leadership
to the organization, creating a culture ensuring medical accuracy
of the company’s scientific strategy.
Ensures all Medical Affairs staff act as company ambassadors,
establishing company awareness and scientific reputation.
Ensures all activities are compliant with global, regional and
local regulations, with appropriate processes and
Provides medical/scientific expertise to cross-functional teams
throughout development and commercialization. As a content expert,
reviews abstracts, publications, medical information letters, and
other medical documents as needed.
Works with R&D to maximize clinical trial execution,
facilitating communications between Company and study
Develops the Scientific Communications strategy to support
global, regional and local objectives, developing and executing
product Publication Plan and Medical Education Plans, including
dissemination of clinical trial results both at scientific meetings
and in peer reviewed journals.
Ensures excellent external stakeholder engagement, working with
cross-functional colleagues, including mapping and profiling of
KOL’s, understanding stakeholder needs and value drivers and
mapping patient journey.
Plans and leads advisory boards and trainings including
development of content and presentation of data.
Develops and leads infrastructure to identify, assess and
execute specific data generation projects to address identified
medical data gaps, including Investigator Initiated Studies.
Ensures rapid and accurate responses to external and internal
medical information enquiries from clinical trial sites.
Ensures operational excellence, including developing and
measuring clear Medical Affairs KPIs, objectives and development
Ensures all relevant insights, knowledge and activity is
systematically captured and disseminated within the company as
Manages resources/budget allocation necessary to deliver on
strategic and operational plans.
Provides a resource of deep scientific expertise in renal
biology and disease, and maintain high visibility among internal
and external peers.
Contributes to the development and maintenance of a positive
team-focused company culture.
MD/PhD/PharmD Ph.D. with 10+ years of experience in the medical
affairs arena is required.
Prior scientific knowledge and experience in the renal disease
arena strongly preferred, specifically glomerular disease.
Alternatively, clearly demonstrated the ability to master a new
therapeutic area deeply and quickly.
Must have 10+ years of medical affairs leadership experience in
the pharmaceutical, biotechnology industry, preferably including
headquarters and field experience.
Requires experience in the evolving healthcare system, with
payers, IDNs or both.
Successfully supported the launch of multiple transformative
drugs, preferably in renal disease space is required.
Must have strong and consistent track record of success,
developing strategy and executing operational plans.
Must possess a strong understanding of medical management
principals and experience with supporting data analytics focused on
outcomes analysis and management.
Prior experience in a decision maker role in a startup life
science company is preferred.
Requires intimate understanding of the role of healthcare
regulators and compliance.
Must have experience in handling media / PR issues.
An ability to form a strong network of influential relationships
with KOLs is required.
Requires a pragmatic business approach to problem solving.
Must be a confident and engaging presenter as part of the
business team and to conference audiences.
Requires understanding the science and business of medicine, and
can speak both languages.
High level of emotional intelligence along with outstanding
ability to lead and inspire others is required.
Must translate concepts and ideas into timely action and
high-impact results; known for both innovation and execution.
Requires strong executive presence, able to communicate complex
ideas with clarity and concision.
High energy, collaborative spirit and an entrepreneurial mindset
Must be comfortable with ambiguity and uncertainty.
Positive attitude and high personal and ethical standards in
achieving corporate goals re required.