Franchise Medical Director, Cardiovascular

Irvine, CA 92618

Posted: 05/30/2019 Industry: Biotech/R&D/Science Job Number: 48955

The Franchise Medical Director will have global medical affairs responsibility in support of the diagnosis and treatment of heart rhythm disorders. In addition, he/she will co-develop and deliver global innovation and life cycle business strategy. This role will also establish long term product opportunities, and evidence needed for development programs and post market products. The Franchise Medical Director will:
  • You will help craft the industry by building positive relationships externally with key partners (Key Opinion Leaders, Surgeons, Regulatory Agencies, Professional Societies, etc.) to anticipate industry trends, understand clinical/medical insights, unmet medical needs and global standards of care in order to deliver quality products/solutions.
  • Ensure the execution of all phases of products' development, establish evidence generation and dissemination strategies for the company' s sponsored and investigator initiated studies.

Duties & responsibilities

Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate procedures and guidelines, this position:
  • The Franchise Medical Director will work with Medical Business Partner to; R&D, Clinical Affairs, Regulatory Affairs, Quality & Regulatory Compliance, Pre-Clinical, Health Economics & Market Access and Professional Medical Education.
  • Ensure the development and execution of product and/or procedural evidence generation and dissemination strategies for company sponsored and investigator initiated research.

Duties & responsibilities

Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate, procedures and guidelines, this position:
  • The Franchise Medical Director will work with Medical Business Partner to; R&D, Clinical Affairs, Regulatory Affairs, Quality & Regulatory Compliance, Pre-Clinical, Health Economics & Market Access and Professional Medical Education.
  • You will participate in the design, development and/or implementation of clinical trials, sponsored by Corporate or Investigator Initiated Studies recommending prioritization and allocation of scientific investment in the region in alignment with Evidence Generation Strategy leaded by Regulatory Affairs.
  • Responsible for ensuring subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition
  • Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
  • Directs the operational function in medical affairs.
  • Leads the design and implementation plans of medical affairs program. Ensures medical affair' s objectives are aligned with the goals and mission of the company.
  • Reviews and approves educational, promotional and reporting materials for use by internal partners. Strategizes and prioritizes publication proposals.
  • Serve as the project champion to insure timeline adherence and project completion. Develops and provides input to research protocols for specific projects promoting company message and value.
  • Directs implements plans for clinical trails, including protocol, staffing and budgeting as it relates to strategic initiatives. Develops policies and procedures for development. Executes plans for continuous improvement to create an environment in Medical Affairs that inspires and recognizes creativity, innovation, collaboration, risk taking and empowerment that develops new product development.
  • Performs other duties assigned as needed

Qualifications:
  • A minimum of a MD/MB/DO or equivalent is required.
  • A minimum of 10 years relevant experience in post graduate medical education (beyond initial licensure), fellowship, subspecialty training,
  • Clinical practice, or dedicated research, is required.
  • At least 3 years of experience as a clinical Cardiac Electrophysiologist is preferred.
  • Additional advanced degrees are preferred.
  • A current license to practice medicine is preferred.
  • Board Certification or an equivalent is preferred.
  • Previous industry experience leading Medical/Clinical/R&D teams in a highly regulated, commercial medical device business is preferred.
  • A minimum of 2 years' experience in clinical practice as an attending level physician is preferred.
  • Significant experience with clinical research is preferred.
  • Demonstrated expertise and success in building Medical Affairs, Clinical Research or Research & Development teams to meet the needs of a global set of businesses serving different clinical specialties or therapeutic areas is preferred.
  • In addition the leader must be able to collaborate well with multiple partners and work effectively in a matrix environment.

REQUIRED KNOWLEDGE, SKILLS, ABILITIES and CERTIFICATIONS/LICENSES:
  • Additional credentials such as FACC, FAHA and/or FHRS are encouraged
Reports to Sr Director (M.D. OR MEDICAL DOCTOR OR DOCTOR OF MEDICINE OR PHYSICIAN ) AND(CARDIAC ELECTROPHYSIOLOGIST OR ELECTROPHYSIOLOGIST OR ELECTROPHYSIOLOGY )

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