VP, Translational & Bioanalytical Sciences

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 unlock the power of gene therapy to accelerate healthcare transformation. 

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

The Head of Translational & Bioanalytical Sciences is responsible for leading Spark’s Translational & Bioanalytical Sciences team. Translational & Bioanalytical Sciences is a cross-functional organization that spans from early preclinical research to clinical development and filing. 

The Head of Translational & Bioanalytical Sciences will play a key leadership role at Spark by providing strategic and scientific leadership to ensure appropriate translational, biomarker and bioanalytical strategies are established and implemented in an efficient and integrated fashion. This individual will partner with Therapeutic Areas in Research and with Clinical Development, serving as a bridge between Research & Development.

Translational strategies address questions to help understand the disease population, establish evidence of target engagement, evaluate biomarkers, assess response, identify and validate surrogate endpoints that can be monitored in advance of clinical efficacy end points.  In addition, Translational Sciences will investigate mechanisms of action, patient enrichment strategies, novel endpoints, and potential new indications.

Bioanalytical Sciences is responsible for the development and validation of immunoassays, molecular and cell-based assays to generate data that enables an understanding of the biodistribution, PK, biomarkers and immunogenicity in support of pre-clinical and clinical development of programs at Spark.

For programs where a clear patient selection strategy is established, the Translational & Bioanalytical Sciences team will also be responsible for partnering with the Companion Diagnostics function to support the development and commercialization of companion diagnostics.

Accountable to the Head of Development Sciences, this individual will serve as a key collaborator with stakeholders internally and represent Spark externally.

Responsibilities

50% of time- Build a world-class Translational & Bioanalytical Sciences organization by

• Managing a team of senior-level PhDs and leaders in the Translational & Bioanalytical Sciences function to optimize for impact to gene therapy programs at Spark by enhancing scientific knowledge, technical expertise and operational efficiency
• For translational – manage and continue to build a team of subject matter experts in various disease areas (CNS, Liver-directed and Ocular) and technology functions for interrogating fluid and cell surface biomarkers, imaging, pathology and histopathology
• For bioanalytical – manage and continue to expand capabilities to new technologies, expand support to include biomarker assays
• Proactively identifying and mitigating scientific gaps pertinent to Spark’s therapeutic areas of interest through self-education, as well as by identifying, interviewing, and incorporating the insights of “best-in-world” experts in order to augment internal knowledge.

50% of time- Develop the strategy and lead company efforts in translational & bioanalytical sciences for successful transition of the organization’s drug discoveries into early-stage and late-stage development programs

• Responsible for defining the translational & bioanalytical strategy from discovery through pre-clinical and clinical development in concert with Research Therapeutic Area leads, Clinical Development leads and biomarker leads in Biometrics
• Define a translational path for portfolio programs to drive novel biomarker discovery and validation.  Enable learning and decision making in early clinical development.
• Establish biomarker and bioanalytical plans in collaboration with therapeutic area (TA) leads, clinical leads, clinical operations, data scientists, biostatisticians and bioanalytical / biomarker laboratories to ensure delivery of high-quality data.
• Support analysis, interpretation, and reports for internal decision-making and Health Authority submissions.
• Establish internal capabilities and external partnerships to develop, validate and implement biomarker and bioanalytical assays
• Serve as reviewer of reports, technical documents and presentations to support IND/CTA/BLA  

Requirements

• PhD, MD or MD/PhD degree with a minimum of 15 years of biotechnology / pharmaceutical industry experience. 
• Prior experience in translational and bioanalytical sciences with a successful proven track record
• Experience overseeing a diverse organization of scientists and operational subject matter experts in the development of bioanalytical and biomarker assays, data generation and interpretation to advance programs
• Ability to effectively present ideas and document complex scientific / clinical concepts in both written and oral communication
• Prior industry experience contributing to the preparation of preclinical and clinical protocols, study reports, IND, IB, NDA/CTD documents
• Knowledge of GCPs, ICH guidelines and FDA regulations and familiarity with EMA/CHMP regulations and guidelines, and other international regulatory requirements.
• Demonstrated ability as a scientific and or medical expert in a complex matrix environment.
• Strong interpersonal and communication skills; proactive approach. Able to work both independently and in a team environment
• Detail-oriented, with good organizational, prioritization, and time management proficiencies. Must be able to work on multiple projects simultaneously
• Demonstrated problem solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency, keen attention to detail, and the ability to successfully execute in an environment under time and resource pressures

Competencies

Setting Strategy

• Demonstrates a long-term perspective that extends beyond the immediate initiatives; visualizes and articulates a clear direction for Spark during times of uncertainty
• Intellectual curiosity and dedication to science, innovation, and complex problem-solving
• Commitment to strategic priorities and an increasingly aligned and disciplined organizational strategy

Executing for Results

• Focuses on how things are done as much as what is done; drives a culture of high performance with increased attention to discipline and process
• Sets aspirational goals to take organizational performance to the next level, reinventing the operating model when appropriate; goes beyond conventional performance benchmarks to set world class best practice
• Navigates change and uncertainty; is agile in responding to feedback from within and outside the organization

Leading Teams

• Embraces and embodies the Spark values: “break the barriers, own your excellence, commit to collaborate, demonstrate the respect you seek, and above all, champion the patient;”
• Able to learn from colleagues, embraces perspectives from different backgrounds and fields, and step back to allow others to take action
• Thoughtfully leads through influence and maintains focus on larger priorities; delegates effectively while managing performance and holding direct reports accountable

Building Relationships and Using Influence

• Collaborates and looks to support other leaders; sees value in championing the work of the group over the individual
• Offers enthusiasm and empathy toward other leaders and their respective departmental goals; influences and ensures alignment toward common priorities
• Able to connect, engage in open dialogue, disagree when necessary, and compromise toward the greater good of Spark

Spark Therapeutics does not accept unsolicited resumes/candidate profiles from any source other than directly from candidates.   Any unsolicited resume/candidate profile submitted through our website or to personal email accounts of employees of Spark Therapeutics are considered property of Spark Therapeutics and are not subject to payment of agency fees.