Ocular Pre-Clinical Research Lead
The Ocular Pre-Clinical Research Lead will manage one or more Ocular therapeutic programs within the Research function.
S/he will be responsible for:
- Directing and overseeing candidate development from early discovery and proof-of-concept through IND enabling studies for specific ocular programs, providing leadership within a group of scientists/research associates.
- Initiation and active oversight of joint programs with external collaborators.
- Establishing and managing project timelines and ensuring work is completed according to schedule.
- Training and developing staff at varying levels of experience.
- Writing and reviewing documents to support regulatory filings, manuscripts, and present results at appropriate scientific meetings.
The Ocular Pre-Clinical Research Lead position supports translational research of gene therapies including:
- Target validation and lead identification/optimization, by using a combination of molecular, cellular and in vitro/in vivo techniques for gene therapy programs.
- Developing strategies to support delivery and transgene expression of our gene therapies in laboratory animals.
- Delivering rigorous, interpretable and scientifically sound IND enabling studies to facilitate product development (e.
g.
proof-of-concept, dose-ranging, GLP-Tox, biodistribution/vector shedding, etc.
)
Responsibilities
% of Time
Job Function and Description
45%
Lead a team of scientists to develop programs through preclinical development and to clinical stage.
Mentor and develop staff.
Develop operational goals and ensure departmental goals and objectives are met and aligned to the broader organizational goals and objectives.
25%
Identify and validate new indication targets.
Design and trouble-shoot experiments based on personal experience and literature review.
Prepare and deliver scientific presentations at internal and external meetings
15%
Prepare sample analysis reports and write parts of regulatory submissions to regulatory agencies.
10%
Prioritize projects, plan workload, manage resource and personnel scheduling.
5%
Hands-on execution of experiments on the bench.
Education and Experience Requirements
- Ph.
D.
in a relevant scientific discipline (e.
g.
cell and molecular biology, biochemistry, etc.
) - 10
plus years of hands-on experience in the field of gene therapy or a relevant field of expertise. - Familiarity with IND enabling studies, regulatory filings, and/or GLP studies is required
- Experience in AAV gene therapy and/or in the ocular space.
- Previous management or supervisory experience preferred.
- Strong publication record is a plus.
- 3
years of management experience - Experience managing external collaborations is a plus.
Manage team members to achieve business goals and objectives.
Foster Spark s Culture.
Role model the Spark Values.
Create an environment where team members thrive by living our truths, always in compliance with applicable laws and regulations.
Emphasize to employees that how they achieve performance objectives is just as important as what they accomplish.
Hire & Integrate.
Know what skills, experiences and capabilities are needed to achieve current and future business goals.
Take an active role in attracting and selecting talent who are inspired by our Mission, Vision and Values.
Consciously create a team with diverse backgrounds, experiences, skill sets and perspectives.
Help new team members successfully integrate into Spark so they can actively contribute and add value as quickly as possible.
Manage performance.
Ensure every team member knows what is expected of them, what it takes to be successful, and how they are progressing.
Provide team members with continuous and on-going performance feedback, holding everyone accountable to achieve results while demonstrating the Spark Values.
Help team members understand how their work contributes to the overall success of Spark by continuously communicating priorities, decisions and changes; adjusting goals as needed.
Develop people.
Understand each individual team member s career goals.
strengths and motivators.
Partner with your employees to identify areas for development, conduct coaching conversations regularly and provide guidance on ways to develop through on the job experiential learning and stretch opportunities.
Key Skills, Abilities, and Competencies
- Hands-on research experience, ideally with gene therapies targeting the eye.
- Strong organizational skills.
- Experience with studies in laboratory animals.
- Excellent communication skills (both oral and written).
- Strong analytical skills and problem-solving capabilities.
- Successful leadership and management experience
Complexity and Problem Solving
- Internal consultant with significant Subject Matter Expertise
- Considered expert in field within Translational R&D
- Develops solutions to complex problems which require the regular use of ingenuity and innovation
- Ensures solutions are consistent with organization objectives
- Work is performed without appreciable oversight
Internal and External Contacts
Serves as consultant to management on major matters pertaining to research and plans
Interfaces with key contacts outside own area of expertise
.Estimated Salary: $20 to $28 per hour based on qualifications.
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