Executive Medical Director

Location
Redwood City, CA
Posted
Jul 26, 2021
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time
Adverum is looking for a Executive Medical Director to join our team in our Redwood City office.  The Executive Medical Director will be responsible for providing clinical leadership in the definition of clinical development strategies, as well as the design, execution, and analysis of clinical studies.   
 
What you'll do:
  • 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

About you:
  • 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

About Us
Adverum is a clinical-stage gene therapy company targeting unmet medical needs in ophthalmology and rare diseases. Adverum develops gene therapy product candidates designed to provide durable efficacy by inducing sustained expression of a therapeutic protein. Adverum’s core capabilities include clinical development, novel vector discovery and in-house manufacturing expertise, specifically in scalable process development, assay development, and current Good Manufacturing Practices quality control.

At Adverum, Inclusion and Diversity are at our core. We believe in the power of being your authentic self.  We strive to create the space which allows for everyone in our Adverum Community to not only feel safe but encouraged to speak, learn from each other, grow in their professions and be the very best versions of themselves no matter what their age, ethnic background, gender, origin, religion or sexual orientation