Executive Medical Director

Company: Adverum Biotechnologies
Location: Redwood City
Posted on: March 28, 2020

Job Description:

We're looking for a candidate to fill this position in an exciting company.

• Lead project Team strategy, scope, complexity, size, budget, and deliverables, overseeing the development strategy, clinical development plan. Provide continual critical evaluation of the development strategy to maintain a plan that is competitive and consistent with current regulatory requirements, proactive identification of challenges, and development of appropriate contingency plans.
• Engage with scientific advisory board, key academic, community, and industry partners, and other thought leaders to innovate and refine clinical development strategies.
• Interactions with regulatory authorities/agencies.
• Lead the design, execution and interpretation of clinical studies in support of product development, ensuring rigorous and compliant study conduct with current health authority regulations.
• Assess clinical data and make clinical program recommendations regarding strategic direction, modification of study plans, go/no go decision and changes in timelines.
• Provide leadership and serve as an advisor to other clinical science, clinical operations, regulatory and scientific colleagues and to cross functional team members.
• Accountable to senior leadership for the timely and successful completion of program objectives
• Other responsibilities may be assigned as needed

• MD or equivalent, board certified or equivalent in ophthalmology desirable
• Clinical practice experience required and strong scientific competence in ophthalmology or related therapeutic area demonstrated by peer-reviewed publications or production of clinical expert reports
• Minimum of 5 years experience in clinical research; with at least 3 years in the pharmaceutical industry
• Must have past work experience of confirmatory drug development and evidence of having played a significant part in the preparation of international regulatory submissions or work with health authorities
• Work with health authorities in outcome measures, presentations, negotiations and submissions are highly desirable
• Strong experience in clinical research including writing clinical study reports and interpreting clinical data
• Proven track record of delivery of experimental or novel studies
• Phase I-III Clinical trial experience in the pharmaceutical industry, academia, or equivalent.
• Proven ability to successfully guide and lead a cross-functional team.
• Ability to interact externally and internally to support a global scientific and business strategy.
• Extensive knowledge of clinical trial strategy, design, execution, regulatory ad compliance (GCP, ICH, etc.) requirements governing clinical trials.
• Ability to exercise good scientific and clinical judgement to proactively identify and address complex problems
• Excellent communications and collaborations skills
• Effective and convincing presentation skills, demonstrated in internal and external group presentations

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