MyoKardia is a clinical-stage biopharmaceutical company pioneering a precision medicine approach to discover, develop and commercialize targeted therapies for the treatment of serious and rare cardiovascular diseases. MyoKardia's initial focus is on the treatment of heritable cardiomyopathies, a group of rare, genetically driven forms of heart failure that result from biomechanical defects in cardiac muscle contraction. MyoKardia has used its precision medicine platform to generate a pipeline of therapeutic programs for the chronic treatment of the two of the most prevalent forms of heritable cardiomyopathy hypertrophic cardiomyopathy (HCM), and dilated cardiomyopathy (DCM). MyoKardia's most advanced product candidate is Mavacamten (formerly MYK-461), a novel, oral, allosteric modulator of cardiac myosin intended to reduce hypercontractility. Mavacamten is advancing into a pivotal Phase 3 clinical trial, known as EXPLORER-HCM, in patients with symptomatic, obstructive HCM and a Phase 2 trial, the MAVERICK-HCM study, in patients with non-obstructive HCM. MYK-491, MyoKardia's second product candidate, is designed to increase the overall extent of the heart's contraction in DCM patients by increasing cardiac contractility. MyoKardia is currently evaluating MYK-491 in a Phase 1b study in DCM patients. A cornerstone of the MyoKardia platform is the Sarcomeric Human Cardiomyopathy Registry (SHaRe), a multi-center, international repository of clinical and laboratory data on individuals and families with genetic heart disease, which MyoKardia helped form in 2014. MyoKardia's mission is to change the world for patients with serious cardiovascular disease through bold and innovative science.
The Executive Director, HEOR and Epidemiology will lead the development and execution of a comprehensive evidence generation strategy to demonstrate the health economic, humanistic and health systems' value of MyoKardia's compounds. You will play a vital role in ensuring that MYOK compounds are reimbursed by payers at prices that reflect appropriate value. Long term success will be measured by that metric. You will collaborate closely with internal stakeholders across the company including partners in Clinical Development, Medical Affairs and Commercial as well as with key external stakeholders including academics, payers, healthcare providers, professional societies and industry partners.
PRINCIPAL DUTIES AND RESPONSIBILITIES
Developing and maintaining an in-depth knowledge of MyoKardia's disease areas, strategies, and relevant clinical, patient, payer and reimbursement landscapes.
Providing subject matter expertise, guidance and direction to internal and external stakeholders, including: recommendations on health economic, epidemiologic and patient reported outcomes evidence needs For MyoKardia's patient populations.
Closely working with cross functional team members, including Medical Affairs and Commercial colleagues to provide scientifically sound, innovative solutions to meet the evidence generation objectives and establish the HEOR evidence strategy to leverage and demonstrate product value, This includes studies to describe and quantify disease burden, treatment patterns, and usage in the real world.
Developing target coverage policies for payers that align product value, unmet need, and clinical evidence.
Playing an active role in pricing strategy to ensure pricing, payer coverage, and HEOR evidence support is well aligned.
Maintain accountability for how payers and HTA's assess value for reimbursement including emerging trends. Ensure the rest of the organization is aware and planning for how these emerging trends may affect clinical and commercial planning.
Ensuring appropriate and relevant health economics and outcome research endpoints are incorporated into the clinical trials and regulatory submissions.
Advising on relevant study designs and protocols for all phases of products in development to ensure the appropriate HEOR considerations and PRO instruments are incorporated into the studies.
Designing, developing, implementing and/or managing studies and HEOR models, communications and tools to support patient access to MyoKardia's products. Ensuring that these efforts are planned in coordination with MyoKardia's Commercial organization to ensure that efforts to demonstrate value are integrated throughout the company.
Developing relationships with Key Opinion Leaders in order to support evidence development
Leading PRO data assessment and incorporation of results from studies into any regulatory submissions and publications.
Participating in publication planning to ensure epidemiology, health economic and outcomes research evidence generation strategies are incorporated into the publication strategy.
Collaborating with Commercial colleagues on messaging around product value.
Maintaining awareness of regulatory requirements, initiatives and advances in epidemiology, and real-world evidence.
Overseeing budget and allocate resources
PhD in Epidemiology, Public Health, Health Services Research or a related field with at least 10 years of relevant pharmaceutical/biotechnology industry experience OR a Master's degree in Health Economics, Epidemiology, or related field, and at least 12 years of relevant pharmaceutical/biotechnology industry experience
Demonstrated hands-on expertise with RW data of different variety (data sources, collection methods, etc.)
A track record of peer-reviewed scientific publications demonstrating expertise in Health Economics, Patient Reported Outcomes, RWE/Epidemiology
Comprehensive knowledge of own core discipline and good working knowledge of health care systems and health technology assessment guidelines and processes in relevant countries.
Ability to understand disease space and appropriately plan and deliver HEOR strategy and studies for specific compounds. Serves as source of expertise/advice for cross-functional team members.
Demonstrated experience in application of HEOR deliverables to achieve payer coverage policies.
Demonstrated experience developing AMCP dossiers and working with payors of various control levels to achieve reimbursement.
KNOWLEDGE, SKILLS AND ABILITIES
Leadership: Experience leading and motivating teams in a matrix environment is required. Proven interpersonal skills with ability to influence, resolve conflict and drive decisions among internal cross functional teams, executive management, and external teams.
Strategic Agility: Ability to develop and execute complex strategies.
Collaboration/Relationship Management: Ability to effectively collaborate in and across multiple functions, and with internal and external stakeholders of various backgrounds and skill sets. Skilled in establishing a collaborative and respectful environment.
Influencing: Ability to lead a matrixed team through influence. Proven track record of influence strategy, initiative(s) implementation, and decision-making. Proactively influences and motivates others to achieve objectives.
Decision Making: Strong decision-making skills taking multiple perspectives into account and analytical skills; sound business judgment.
Communication: Excellent communication skills (both oral and written).
Business Excellence: Ability to develop the processes necessary to get things done, knows how to organize people and activities and knows what to measure and how to measure. Demonstrated ability to interpret data into actionable items.
Negotiation: Proven negotiation skills that effectively drive discussions and decisions to desired end-results that have broad organizational impact.
Alignment: Proven track record of achieving alignment with internal and external stakeholders.