Vice President Of Clinical Affairs

4 weeks ago

San Jose, United States TGI Life Sciences Full time

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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