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Biomarker Leader

Date: Jul 17, 2021

Location: Philadelphia, PA, US

Company: Spark Therapeutics

Join the Spark Team

 

We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable – until now.

 

We don’t follow footsteps. We create the path.

 

Primary Duties:

The Biomarker Leader will be a member of the Bioanalytics department and will be responsible for devising and leading the discovery and implementation of biomarker and diagnostic strategies across Spark Therapeutics gene therapy development programs.  The successful candidate will build and direct a team tasked with the development and validation of biomarker assays along with sample analysis. S/he will interface with project teams to translate biomarker needs to relevant assay and sampling parameters from discovery through development. In addition to fluid biomarkers for multiple disease areas, imaging markers for neurodegenerative indications such as MRI and PET will be required. The candidate will also lead the development and qualification of Companion Diagnostics as required. S/he will serve as a scientific and technical expert on projects and will work with external partners (CROs) as needed to transfer internal assays and provide guidance, troubleshooting and quality oversight. The incumbent will participate in clinical study design and clinical study reports and contribute to and author relevant regulatory submission document (pre-IND, IND, IB, BLA, etc.) and present biomarker strategy and data at internal meetings and represent Spark externally in biomarker networks of excellence.

 

Responsibilities:

% of Time

30         

     Manage biomarker teams 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.

 

50  

Independently formulate translational strategies for the discovery, development, and   implementation of biomarkers for ultimate use in clinical settings. Provide strategic and scientific leadership to biomarker team responsible for assay development and qualification/validation as well as pre-clinical and clinical sample analysis while ensuring compliance with regulatory guidelines.

10

Author, review and approve biomarker-related content of regulatory documents (including pre-IND, IND, IB, BLA, etc.).

10

Provide scientific and strategic input in the evaluation of new technologies and over-sight of outsourced biomarker assays at CROs

 

Education and Experience Requirements:

  • MD, PhD or equivalent advanced degree in biology or related field required and 10+ years of related experience with at least 3 years of industry experience in biomarker assessment for biologics and/or gene therapy products
  • At least 5 years management experience
  • Previous experience as a leader of biomarker assays in a regulated environment

 

Key Skills, Abilities, and Competencies:

  • Deep understanding of biomarkers and bioanalytics
  • Ideally, experience with both fluid and imaging biomarkers for neurological indications
  • Experienced and proficient in the development and validation of biomarker assays
  • Working knowledge of GLP, GCP, SOPs and regulatory guidelines related to biomarker assessment
  • Experience in developing biomarker strategy in collaboration with clinical and regulatory functions
  • Experience with companion diagnostic assays desired
  • Demonstrated scientific knowledge and abilities to achieve high barrier scientific goals
  • Experience in writing biomarker sections of regulatory documents
  • Excellent communication skills with the proven ability to work effectively as a member of a multidisciplinary team and in a matrix environment
  • Continuously drives scientific and technological innovation
  • AAV gene therapy experience a plus
  • Experienced people manager who leads by example and utilizes leadership skills to supervise a team and manage the professional development of the group
  • Able to work collaboratively in a multi-cultural fast-paced environment with ability to handle multiple tasks, and set priorities to meet study timelines

 

Complexity and Problem Solving:

  • Ensures that strategy, structure and activities of the team are consistent with organization objectives
  • Continuously evaluate and prioritize bioanalytic capabilities to fully support the portfolio. 
  • Provides solutions to complex problems which require the regular use of highly specific knowledge, ingenuity and innovation in matrix environment
  • Considered an expert in the field within the organization as well as externally

 

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Nearest Major Market: Philadelphia