HCM Therapeutic Lead

At Cytokinetics, each team member plays an integral part in advancing our mission to improve the lives of patients. We are seeking tenacious, compassionate, and collaborative individuals who are driven to make a positive impact.

The Global Lead, HCM, Medical Affairs will assume a key role within the organization. S/he will work collaboratively with other members of the Medical Affairs team in the development and execution of the Medical Affairs plan for the HCM franchise with focus on aficamten as well as collaborate cross-functionally with the Commercial and Clinical departments in the strategic planning and life-cycle management process of our HCM portfolio.

As a subject matter expert in cardiology and hypertrophic cardiomyopathy, the Global Lead will provide support to internal colleagues, resolve medical issues, and provide critical input into the development of HCM medical documents (publications, external scientific communications, standard response letters, training materials, product materials, research ideas, internal training materials, etc.) to ensure high strategic and scientific standards. Importantly, the Global Lead will serve as a key member of the Medical Affairs HCM team. S/he will represent Medical Affairs externally through presentations at advisory boards, key scientific meetings, and interactions with our key investigators. Additionally, the Global Lead will support strategic partnerships with key opinion leaders, academic institutions, and professional societies.

Responsibilities

• Serve as the Global Medical Affairs lead for the launch of aficamten, including development of strategic vision, execution of medical launch activities, and education of HCPs
• Lead and manage day‐to‐day clinical and medical guidance while working closely on joint projects with other members of the Medical Affairs team and other departments within Cytokinetics and our business partners. Projects may include scientific congress/conference strategy and planning, advisory boards, field force training, review of medical information standard response letters, health economics and epidemiology analyses, and marketing/policy related projects.
• Partner with European and ex-US Medical Affairs and cross-functional personnel to assure global harmonization of aficamten efforts and data promulgation
• Expand and maintain an active global KOL HCM expert network
• Lead scientific input into publication strategy for the HCM therapeutic area, including review of abstracts and posters for presentation at scientific meetings and manuscripts for publication
• Establish the scientific and clinical priorities for an investigator sponsored study program and chair the internal review committee that adjudicates submitted research proposals
• Serve as Medical lead on appropriate cross‐functional Medical and Commercial teams to inform brand strategies and tactics for aficamten
• Lead strategic planning and implementation of HCM medical education, grant, and sponsorship programs
• Provide clinical and scientific support in responding to inquiries from healthcare professionals
• Support the Medical Affairs review of medical and promotional scientific materials related to HCM and aficamten
• Present data at company advisory board meetings and training programs
• Lead specific data generation projects to address identified medical data gaps
• Identify and effectively interact with HCM external experts to engage in scientific exchange to meet the needs of patients and the medical community
• Collaborate with HEOR function to define HCM research strategy and design of studies
• Lead Medical content for Medical Affairs initiatives including collaboration with the MSL team including the development of materials for external medical interactions and to address healthcare professional inquiries
• Upon initiation of a Phase 4 program, lead the review and adjudication of investigator-initiated research proposals

Qualifications

• MD/DO (cardiovascular and HCM training and clinical research and/or Medical Affairs experience preferred, board certification/eligibility desirable) with 8+ years of related experience
• Medical Affairs experience with medicine approvals and peri-launch activities
• Background in academic medicine, clinical research, and familiarity with biostatistics and epidemiology are highly desirable
• Prior experience in the biotech/pharmaceutical industry is a plus
• Familiarity with OPDP, PhRMA code, and key regulations in the pharmaceutical industry is a plus
• Proven ability to work independently and as a member of an integrated, interdisciplinary team in carrying out assigned responsibilities
• Must be analytical and articulate in both oral and writing skills, possess excellent presentation skills, with a demonstrated ability to communicate well with others at varying professional levels
• Proficiency with Microsoft Office
• Ability to travel domestically and internationally (~30% of the time)