Vice President Of Clinical Affairs
3 weeks ago
An exciting opportunity to join an early Medical Device start up company based in California. focusing in the sector of Urology the ideal candidate for the role must have experience in this field and with BPH.
Reports to the President/CEO and serves as a key and active member of the Senior Management/Executive team, interacting with the team to ensure business objectives are aligned and that the company is performing
to operational objectives. Responsible for the overall medical device clinical regulatory program development
and implementation, as well as the Clinical management of the company. Develops and executes regulatory
strategies that will expedite product development while minimizing costs. Ensures company policies,
procedures and operating guidelines conform to laws, regulations and industry practices. Coaches and mentors
the members of the organization ensuring appropriate levels of accountability for decision making regarding
clinical, and regulatory requirements and clearly communicates cross functionally within the organization.
MAJOR DUTIES AND RESPONSIBILITIES:
Provides management and leadership to the Clinical and Regulatory organizations in the
development and implementation of clinical and regulatory strategies and processes to gain fastest
to market product approvals.
Provides leadership and direction for significant deviation events that may impact compliance status
or significant business risk.
Provides counsel, training and interpretation of FDA, Health Canada, EMA, and other international
regulatory requirements to all company personnel.
Directs and manages all regulatory submissions and communications to regulatory authorities.
Ensures timely preparation of organized and scientifically valid submission. Evaluates need for
external expertise for submission preparation and filing of all regulatory documents.
Maintains external positive relationships with key opinion leaders, medical directors and regulatory
officials.
Identifies issues that may increase regulatory and corporate risks and proposes informed strategies
to address such risks.
Directs the development of systems, practices and processes to ensure effective ongoing review of
product design and/or manufacturing changes and adverse events. Maintains knowledge and
familiarity with the regulatory environment and latest regulatory issues, and provides expertise in
translating regulatory requirements into practical, workable plans.
Develops and successfully executes clinical and regulatory strategies and implementation plans to
ensure product approval and adoption while meeting corporate objectives within applicable
regulations and guidelines.
Directs team development and growth to meet companys clinical and regulatory requirements
while remaining within budget.
Present to board of directors, when needed, all updates and short- and long-range planning for
clinical and regulatory functions.
Job Title: Vice President, Clinical Affairs
Provide support to CEO during company fundraising by providing documents and data to be
presented to potential strategic/investors.
Participate in meetings with potential strategic/investors as needed and present clinical and
regulatory status.
EDUCATION/EXPERIENCE REQUIREMENTS:
BS degree in scientific discipline, MS preferred
SUPERVISORY RESPONSIBILITIES:
The EVP of Clinical, and Regulatory oversees all Clinical, and Regulatory roles within the
organization, including consultants.
EXPERIENCE / KNOWLEDGE / SKILL REQUIREMENTS
Experience
Minimum 10 years of leadership experience in clinical and/or regulatory and quality in medical
device and/or pharmaceutical industries.
Knowledge/Skills
Working knowledge of ICH/GCP guidelines.
Knowledge of FDA, Health Canada, and EMA regulations and guidance
Clinical Trial Design and Management and Regulatory affairs certification or equivalent
21 CFR 820 and ISO 13485 certification or equivalent
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