Director of Clinical Development - Menlo Park, CA | Biospace
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Director of Clinical Development

Adverum Biotechnologies, Inc.

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Location:
Menlo Park, CA
Posted Date:
5/16/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Masters Degree
Areas of Expertise Desired:
Clinical Operations, Director, MD,

Job Description

Adverum is a gene therapy company committed to discovering and developing novel medicines that can offer life-changing benefits to patients living with rare diseases or diseases of the eye who currently have limited or burdensome treatment options. We are looking for a Director of Clinical Development who will participate in the development of all stages of our Clinical Development (CD) strategy.  This position will plan and support the Chief Medical Officer with various deliverables necessary for effective and efficient CD planning and execution.

The Director of Clinical Development is a key team member whose primary responsibilities will depend on stage of disease program. The Director may  lead the overall rare disease program or represent CD on project teams, acting as the single point of contact to address study inquiries, support training of study site personnel, conduct ongoing medical/safety data reviews, provide clinical science input into study reporting, and collaborate with external advisors.

Essential duties and responsibilities include but are not limited to the following:
• Will establish and drive teams to execute the strategic long-term vision for key pipeline drug candidate(s)
• Develop and maintain clinical protocols and amendments, investigator brochures, and clinical study reports
• Contribute to the strategic development of early to late stage clinical programs
• Responsible for clinical development project teams for rare disease programs
• Addresses CD study or other program-specific questions, provides updates, delivers presentations and guides clinical decision making/ issue resolution
• Assist in the development of timelines, and budgets, relevant to the management of clinical development
• Ensure timely publication of clinical trial results
• Evaluate safety, pharmacology, and efficacy data from ongoing and completed studies
• Maintains scientific and clinical knowledge in Alpha 1 Anti-trypsin Deficiency, Hereditary Angioedema and other specific therapeutic and disease area(s) of assignment
• As appropriate, participates in ongoing enhancements and development of team processes, structures, and tools
• As appropriate, participates in competitive intelligence and/or other market/industry assessment activities and projects
• Collaborates with a variety of internal and external partners and stakeholders, such as clinical investigators, clinicians, scientists and KOLs, as well as internal groups, including, research, CMC, operations, legal and business development
• Assist with the coordinate the successful completion of documents with other groups
• As needed/appropriate collaborates with others in the review of safety narratives and other safety-related guidelines and documentation
• Develops and provides input for clinical presentation slides and other materials for internal/ external meetings and ongoing communications
• Where assigned, acts as the primary CD liaison/point-of-contact from the team for medical monitor inquiries from clinical operations, clinical research organizations (CROs), etc.
• Accountable for writing and/or reviews abstracts, posters, content for scientific meetings, conferences, other events and presentations, and other publicly distributed materials and coordinates further reviews with internal partners and stakeholders
• Coordinates submissions to scientific meetings and/or other appropriate venues or groups

Requirements

Position Requirements and Experience:
• M.D. or Masters/Ph.D. in Biological Sciences, Pharmacology or a related scientific discipline
• 12+ years of clinical research and/or clinical development experience within the biotech industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of mentioned.)
• Ability to proactively predict issues and solve problems
• Ability to drive decision-making within a multi-disciplinary, multi-regional, matrix team
• Diplomacy and positive influencing abilities
• Therapeutic area knowledge relevant to mechanism of action
• Understanding of US Regulatory requirements
• Emerging research experience in rare diseases and/or gene therapy