Medical Director, US Medical Affairs, HCM

Cytokinetics•South San Francisco, CA

1d•$276,120 - $322,140•Hybrid

About The Position

The Medical Director, US Medical Affairs, Hypertrophic Cardiomyopathy 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 aficamten and partner cross-functionally with the Commercial and Clinical departments in the strategic planning and life-cycle management process of our CV portfolio. As a subject matter expert in cardiology and hypertrophic cardiomyopathy, the Medical Director will provide support to internal colleagues, resolve medical issues, and provide critical input into the development of 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 Medical Director will serve as a key member of the Medical Affairs Hypertrophic Cardiomyopathy team. S/he may represent Medical Affairs externally through presentations at advisory boards, key scientific meetings, and interactions with our key investigators. Additionally, the Medical Director will support strategic partnerships with key opinion leaders, academic institutions, and professional societies.

Requirements

MD/DO or PharmD with prior pharmaceutical industry and Medical Affairs Medical Director experience with 3-5 years of Medical Affairs experience required.
Cardiovascular training and clinical experience strongly preferred.
Demonstrated knowledge of Medical Affairs strategy, including evidence generation, scientific communications, and external engagement strongly preferred.
Prior experience with product approvals, launch, and peri-launch activities highly desirable.
Background in academic medicine, clinical research, and familiarity with biostatistics and epidemiology highly desirable.
Prior experience with management of vendors, budgets, and strategic timelines a plus.
Experience developing medical plans and aligning medical objectives with broader product and organizational strategy a plus.
Familiarity with OPDP, PhRMA code, and key regulations in the pharmaceutical industry a plus
Ability to critically evaluate and interpret clinical trial data, peer-reviewed literature, treatment guidelines, and real-world evidence.
Proven ability to work independently and as a member of an integrated, interdisciplinary team in carrying out assigned responsibilities.
Proven ability to translate complex scientific information into clear, accurate, and actionable medical guidance.
Strong project management skills, including ability to manage multiple priorities, budgets, vendors, timelines, and deliverables.
Working knowledge of congress strategy, advisory boards, medical education, and scientific communications.
Must be analytical and articulate in both oral and in writing skills, possess excellent presentation and executive communication skills, with a demonstrated ability to communicate well with others at varying professional levels
High level of scientific integrity, sound medical judgement, professionalism, and commitment to patient benefit.
Proficiency with Microsoft Office
Ability to travel (~30% of time)

Responsibilities

Supports the ongoing development of aficamten, including Assist in development and execution of medical strategy, including the US Plan of Action, aligned with organizational, therapeutic area, and product objectives
Serve as a medical and scientific expert for the assigned therapeutic area
Educate HCPs regarding the clinical profile of aficamten and its place in HCM therapy
Provide medical leadership throughout aficamten development, launch readiness, and lifecycle management
Execution of medical launch activities
Provide medical input into cross-functional, brand, evidence generation, market access, and lifecycle management plans
Provide medical expertise and input for REMS activities
Partner with Clinical Development, Commercial, Regulatory, Safety, HEOR, Market Access, and Legal/Compliance on key strategic workstreams and deliverables. Projects may include scientific congress strategy and planning, advisory boards, field force training, review of medical information standard response letters, health economics and epidemiology analyses, and marketing and policy related projects
Collaborate with regional and global colleagues to ensure aligned strategy while effectively addressing local stakeholder needs
Participate in appropriate cross‐functional Medical and Commercial teams to inform brand strategies and tactics for aficamten
Provide input into hypertrophic cardiomyopathy medical education, grant, and sponsorship review and review metrics to evaluate the reach, quality, and impact of medical education initiatives.
Manage medical programs, vendors, timelines, budgets, contracts, and performance measures.
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 hypertrophic cardiomyopathy and aficamten via MLR
Participate in development of integrated evidence plan strategy (IEP), including identification of evidence gaps and contribute to evidence generation strategy including real-world evidence and investigator-sponsored research
Collaborate with Field Medical Affairs to establish scientific priorities, training plans, and insight and stakeholder engagement strategy.
Analyze field medical insights to inform medical, evidence generation, and educational strategy
Collaborate with US Field Medical Affairs to support field material development and address healthcare professional inquiries
Assist in Field Medial education for emerging aficamten data and HCM topics
Build and maintain an active US KOL HCM expert network
Identify and effectively interact with hypertrophic cardiomyopathy external experts to engage in scientific exchange to meet the needs of patients and the medical community