Executive Director Pharmaceutical Development

Location
Redwood City, CA
Posted
Apr 18, 2021
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time
Adverum is seeking to hire an Executive Director, Pharmaceutical Development, to join our team in our Redwood City office to support early preclinical work in the field of AAV-based ocular gene therapy. This position will report in to the Vice President, Pharmaceutical Development, and will be responsible for leading the Preclinical arm at Adverum.  This highly functioning department covers oversight of both preclinical pharmacology, as well as assay development/bioanalysis as it relates to the Research and IND-enabling preclinical studies.  Direct reports include the Associate Director of Preclinical Operations, as well as the Director of Translational Sciences.   The individual will work in collaboration with other internal functional leads (CMC, Regulatory, Clinical) in order to help set the vision and drive execution ensuring actions and deliverables are of quality standards, on-time, and within budget, while achieving required compliance. This position will also provide scientific input into the long-term vision and growth strategy for the product portfolios, as well as providing input in pipeline expansion.  This exciting role is a great opportunity for a highly motivated individual to apply scientific acumen and leadership in a highly collaborative and supportive culture in the ever-expanding gene therapy field.
What you'll do:
  • Manage and direct the Company’s Preclinical department for the evaluation of new AAV-based gene therapy products and the improvement of existing products.
  • Oversee and drive Preclinical pharmacology studies, ensuring that budgets, timelines, staffing, and other corporate/program goals are met.
  • Oversee preclinical studies, including experimental design, data interpretation, report writing and review, and ensuring that reports comply with regulatory agency guidelines
  • Oversee Assay Development activities (method development and sample analysis) as they relate to Research and IND-enabling studies.
  • Work collaboratively with Sr. Dir of New Vector Technologies to identify novel capsid variants for both ophthalmic and nonophthalmic indications
  • Represent the Company’s Preclinical and Research organization by giving presentations at scientific conferences, internal company-wide meetings, at Board Meetings, and in scientific discussions with potential partners (supporting the Business Development group).
  • Expand the pipeline to include additional ophthalmic indications that leverage the expertise from existing products, taking into account market potential and unmet need; design and confirm resourcing of studies needed to establish POC for new indications using AAV-based gene therapy approaches
  • Coach and mentor staff including direct reports to ensure appropriate levels of accountability for deliverables according to core competencies and values, with clearly communication across Adverum
  • Work with LT and Business Development group to development Research strategy of Company
  • Measure performance through defined performance, quality and compliance metrics
  • Regularly interface with the CMC. Clinical and Regulatory departments, to ensure integration of preclinical and clinical development plans in order to de-risk clinical activities, as well as to provide input to preclinical sections of all regulatory documents in preparation for the submission of preIND Briefing and IND documents
  • Prepare manuscripts for publication in peer-reviewed journals; regularly communicate updates in publication plan with supervisor; propose abstract ideas for submission at conferences in order to showcase Company pipeline development activities, as well as preclinical studies supporting current clinical products. 
  • Model and encourage adherence to Adverum’s Values and Mission
  • Other responsibilities may be assigned as needed

About you:
  • Ph.D. in Pharmacology, Biochemistry, Molecular Biology, Genetics, or related field
  • Preferred experience in AAV-based gene therapy approaches to treat ophthalmic and rare diseases.
  • Highly self-motivated and comfortable operating in an entrepreneurial, fast paced, and non-siloed environment
  • 12+ years of relevant experience in a biotechnology company, with a focus on early target discovery, animal model development and validation, preclinical development of ocular therapeutics is preferred but not required. 
  • 10+ years of demonstrated successful experience in leading teams and managing budgets.
  • Strong leadership, people management, project management, and process improvement abilities.
  • Excellent oral and written communication skills, including presentations to large groups, and attention to detail and ability to understand, interpret and explain preclinical data and research study results, in the context of the bigger (clinical) picture, to audiences of varying backgrounds
  • A demonstrated track record of driving performance and leadership ability within a team environment
  • Demonstrated ability to attract, build and motivate a team of high-functioning individuals
  • Highly resilient and achievement-oriented, with the ability to succeed in an environment that demands fast but well-founded decision-making on a vast number of multidisciplinary issues
  • Experience interacting with the FDA and other regulatory agencies is preferred, in collaboration with Clinical/Regulatory team
  • Demonstrated ability to exercise sound scientific judgment including the ability to communicate (verbal and written) complex preclinical matters in an understandable and scientifically sound manner
  • Ability and willingness to travel both domestically and internationally




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