MICHAEL CODY

Work History

Vice President and Head of Medical Affairs

SHIELD THERAPEUTICS, Plc

01.2021 - 01.2024

Reported directly to the CEO
Responsible for the creation, development, and execution of all US medical affairs strategic initiatives and medical operating plans to successfully support Shield’s business goals
Responsible for the medical affairs budget of $4 million dollars, working with the CMO and CFO to ensure efficient and effective allocation of resources for medical affairs
Clearly and skillfully aligned medical strategies with changing commercial focuses by providing outstanding clinical leadership and guidance both to the medical team and with cross-functional partners
Worked closely and compliantly with VP of Clinical Development, VP of Marketing and VP of Commercial
Responsible for and supervised all initiatives in Medical Education, creating 5, high-impact CMEs in our key KOL universe including: Women’s Health, OBGYN, and Primary Care
Co-created and co-moderated with NPWH, 2 highly successful and impactful educational trainings (Fireside Chats) featuring prominent thought leaders in both Primary Care and Women’s Health
Also responsible for the sponsorship, creation and co-moderation of 8 advisory boards, providing Shield with key insights and competitive intel from key Thought Leaders in our scope of practice and patient care
Responsible for the creation, development, and execution of Shield’s publication plan, gaining the acceptance of 4 abstracts, 2 poster presentations and multiple publications
Responsible for identifying and fostering strong, relationships with key Thought Leaders within iron deficiency, iron deficiency anemia, Women’s Health, and Primary Care
Responsible for the management and oversight of US medical information and communication, working collaboratively with the UK Head of Medical Information and the medical information vendor and budgets
Represented Shield externally to all medical/clinical societies such as ACOG, NPWH, AANP, FMX, advocating for the underserved and unmet medical need of iron deficiency and iron deficiency anemia, fostering strong, strategic partnerships in advancement of needed medical initiatives
Worked closely with the VP of Clinical Development to review and oversee the current post-marking studies as well as support for global partners with studies and planned launches
Responsible for leading, training, on-boarding, and management of the MSL team and all field Medical Affairs initiatives
Acted as sole medical reviewer for the Medical/Legal Review (MLR) committee

Executive Director, Medical Science Team

RELYPSA, INC, a VIFOR PHARMA COMPANY

01.2017 - 01.2021

Responsible for a team of 17, including: 14 Medical Science Directors (MSD); 2 Regional MSD Team leads; and one Training and Operations Director
Successfully hired and promoted 2 MSDs to Regional Team Leader positions
Responsible for a budget of $15 million dollars
Successfully managed and led the entire MSA team in the launch of a new co-promoted product
Lead the development and execution of all medical strategies for the MSD team, supporting the Medical Affairs’ Operating Plan (MOP)
Lead the development and implementation of processes to successfully identify, establish, and maintain collaborative relationships with Key Opinion Leaders (KOLs) including hyperkalemia, Nephrology, Heart Failure, and Endocrinology experts
Created curriculum and oversaw the training efforts for every member of the field medical team
Ensured efficient and effective cross-functional collaboration between the MSD team and internal departments such as Drug Safety, Clinical Development, Regulatory/Legal/Compliance, and Commercial and Marketing
Created and implemented the first MSD career ladder and development program for the MSD/MSA teams
Provided and supported global medical training for Vifor Pharma medical and commercial teams

Senior Medical Science Director, WEST Team Lead

RELYPSA, INC, a VIFOR PHARMA COMPANY

01.2016 - 01.2017

Recognized as a strong leader in the company via promotion to Executive Director, Field Medical team
Managed a team of 7 MSDs, covering the western half of the United States, including hiring and firing responsibilities
Worked with Executive Director and senior MSA leadership team to develop and manage a robust KOL network
Responsible for developing strategies specific to the West MSD team to support the successful execution of Medical Affairs strategies, tactics, and MOP
Worked effectively with cross-functional internal partners including Drug Safety, Clinical Development, Regulatory/Legal/Compliance, and Commercial and Marketing
Developed and maintained a comprehensive understanding of scientific/clinical data related to hyperkalemia treatment and other associated disorders
Developed and maintained on-boarding, training, and mentorship programs for the team
One of the first Relypsa employees to be accepted into and successfully complete the Vifor Pharma Management Program (VPMP2, 2017)

Medical Science Director

RELYPSA, INC.

01.2015 - 01.2016

Recognized as a rising leader within the company via promotion to Senior MSD, West Team Leader
Developed and maintained clinical knowledge expertise in the hyperkalemia treatment landscape including current treatment strategies, and new therapeutic developments
Organized and lead weekly MSD journal club teleconferences and executed detailed summaries to team
Developed and ensured alignment in medical education activities for healthcare professionals through MSD-delivered presentations; participation in medical meetings; and, other appropriate venues to enhance product and disease state knowledge
Collaborated with the Relypsa clinical team, medical monitors and CRA's to coordinate and optimize educational and research support for sites/investigators participating in Relypsa’s clinical trials
Served as liaison to KOLs submitting investigator sponsored studies (IIS)
Ensured alignment on content of effective clinical presentations provided to internal and external audiences, ensuring presentations are tailored to meet the specific needs of the audience
Identify educational needs within the medical community around hyperkalemia disease state management
Acted as peer leader and mentor for newly onboarded MSDs
Awarded SPOT award for recognition as a leader among the MSD team (2015)
Awarded a Values in Action, Achievement through Excellence award (2015)

Medical Science Liaison

HYPERION THERAPEUTICS

01.2014 - 01.2015

Established professional relationships with thought leaders, academic institutions, and managed care communities in the field of genetics and metabolic disorders
Presented critical medical and scientific information to KOLs to address proactive and reactive unmet medical educational needs
Collaborated with cross-functional teams to develop strategies to assess the education and research needs within the rare disease community
Assisted in the identification of investigators and sites for company trials
Served as a liaison for the review, submission, execution, completion of IIS (Investigator Initiated Studies) proposals and facilitate the initiation of research projects
Organized, led, and represented the company at key scientific meetings such as the Society for the Study of Inborn Errors of Metabolism (SSIEM 2014), Innsbruck, Austria

Medical Science Liaison

SANOFI (Formerly GENZYME)

01.2010 - 01.2013

Established, cultivated, and leveraged relationships with Global, National, and Regional KOLs around clinical and medical practice and research regarding Chronic Kidney Disease (CKD) and Mineral and Bone Disorder (MBD)
Supported and moderated advisory board meetings and speaker training initiatives
Maintained cross-functional collaborations with internal customers such as Global Marketing, Global Medical Communications, US Marketing, and Sales
Active member of the following committees: Scientific Review Committee, Medical Review Committee, Publication Review Committee, and Commercial Review Committee
Created, planned, and conducted global training for both medical affairs and sales colleagues in the United Kingdom
Successfully completed a preceptorship with our Global Medical Communications department to organize and deliver 3 medical consultants’ forms in Hong Kong, Madrid, and Istanbul
Delivered medical presentations to diverse audiences including renal nephrologists, renal fellows, regional dietitians, and pharmacists
Represented KOLs with their Investigator Initiated Studies (IST) through our Medical Research Committee
Contributed to publication planning, and development of medical education and materials for internal training
Participated in one-on-one mentoring of new MSLs
Awarded a SPOT achievement award from the Global Marketing team for innovation and collaboration

Medical Science Liaison/Clinical Science Consultant

BOEHRINGER INGELHEIM PHARMACEUTICALS

01.2009 - 01.2010

Provided educational consultations to Key Opinion Leaders including Pulmonologists, Neurologists, and Primary Care Physicians
Present in-depth, on-label, and fair-balanced clinical information to targets, including Key Opinion Leaders, focusing on Chronic Obstructive Pulmonary Disease (COPD), Transient Ischemic Attacks (TIAs) and secondary stroke prevention including: diagnosis, management, and treatment
Actively seeking out and creating strong KOL relationships through literature searches; attending conferences and symposiums; and researching teaching hospitals and institutions
Demonstrated proficiency in pre-call planning and travel planning to reach and service a territory covering 100 Key Opinion Leaders, covering 5 states

Clinical Science Consultant

PFIZER INC.

01.2008 - 01.2009

Managed a territory consisting of 80 CNS Key Opinion Leaders representing Pfizer for clinical information on 3 billion-dollar drugs: Aricept, Celebrex, and Lyrica
Worked extensively as a Medical Consultant with these drugs in the specialty areas of Pain Management and Inflammation and CNS
Traveled daily to facilitate clinical discussions and conduct workshops with KOLs and acted as a consultant to physicians and Key Opinion Leaders, creatively exercising my clinical knowledge, sales, and marketing background to meet their needs and exceed expectations
Created and executed marketing plans to maximize interactions with physicians and Key Opinion Leaders

Clinical Specialist/Medical Sales Liaison

PAJUNK MEDICAL DEVICE SYSTEMS

01.2007 - 01.2008

Company Overview: (Specializing in Regional Anesthesiology: creators of the world-renowned, Sprotte Spinal Needle)
Traveled nationally and globally to market and present information to Key Opinion Leaders on medical systems products: major areas of expertise in Pain Management
Focused daily on building and maintaining a strong KOL constituency
Supported international trade shows and medical conferences, and congresses
Actively communicated with Vice Presidents of both Research and Development and Medical Affairs to gain extensive knowledge of our company and our products to create valuable training tools to expand product knowledge for medical and sales teams
Lead the first US marketing campaign in promotion of Pajunk’s number one product, the Sprotte Spinal Needle
(Specializing in Regional Anesthesiology: creators of the world-renowned, Sprotte Spinal Needle)

Medical Student/Resident Doctor

UNC-CH SCHOOL OF MEDICINE

01.1995 - 01.2002

Highly trained in all areas of Anesthesiology including general, regional, and pain management
Organized and executed daily surgical plans and monitored vital signs in preparation for patient discharge, reported to Chairman of Surgery
Highly trained in the usage of surgical supplies, instrumentation, and most operating room materials
Trained in neurosurgical, surgical, neonatal, pediatric, and cardiac critical care environments
Supervised 10 - 15 first-year residents in extremely complex procedures in Anesthesiology, ranking me in the top 1% of my class in excellence of execution and leadership

Clinical Research Assistant, Orthopedic Physiology

BOWMAN GRAY SCHOOL OF MEDICINE

01.1994 - 01.1995

Studied the microcirculation in rabbit ears as a model for human hands and feet in such disorders as Raynaud's phenomenon
Developed and presented research finding to department heads and faculty
Experienced in program management; writing patient summaries; and publishing charts

Summary

Overview

Work History

Vice President and Head of Medical Affairs

Executive Director, Medical Science Team

Senior Medical Science Director, WEST Team Lead

Medical Science Director

Medical Science Liaison

Medical Science Liaison

Medical Science Liaison/Clinical Science Consultant

Clinical Science Consultant

Clinical Specialist/Medical Sales Liaison

Medical Student/Resident Doctor

Clinical Research Assistant, Orthopedic Physiology

Education

M.D. -

BS - Biology, Pre-Med, and French minor

Skills

References

Languages

Timeline

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