Head of Toxicology and Pharmacology

Primary Duties

The Head of Toxicology and Pharmacology will play a key leadership role in providing input to the Therapeutic Areas (TAs) at Spark, as the strategy for in vivo pharmacology and toxicology studies is being developed to support gene therapy programs at Spark. This role will contribute to the strategic growth of the Research organization as a member of the Research Leadership Team.

The individual will be responsible for building a team of Toxicology experts to partner with the Therapeutic Areas (TAs) in developing the strategy for design and interpretation of safety and toxicology studies in support of programs in late discovery through development. In addition, the team will assist the TA leads, as needed, in the design, execution and interpretation of investigative and pharmacology studies. The team will be responsible for supporting Therapeutic Area Leads in all aspects of non-clinical safety and pharmacology as needed.

Other functions within Toxicology and Pharmacology will include an in vivo operations team responsible for execution of in-house preclinical studies, and oversight of outsourced studies.

Toxicology and Pharmacology will also be responsible for co-authoring regulatory documents, including relevant sections of IND and CTA submissions.

Responsibilities

Provide strategic direction and ensure execution on nonclinical efforts across multiple programs from discovery through clinical development.

• Collaborate with internal project teams and leadership to develop and drive integrated non-clinical safety, pharmacology, and toxicology strategies
• Support the design of non-GLP investigative and pharmacology studies as needed to identify and mitigate treatment-related toxicities in early discovery stage programs at Spark
• Work with the Therapeutic Area leads to develop in vivo efficacy packages that support advancement of programs from initial proof of concept through FIH studies
• The following activities will be the responsibility of the Toxicology and Pharmacology group. The Head will be responsible for these activities either directly or indirectly.

Support in vivo pharmacology studies according to priorities of the disease areas and the Discovery platform team when requested.

Assist / support the TA Heads in the planning and oversight of non-clinical safety studies, including exploratory and GLP studies.

Critically evaluate, interpret, summarize, and present non-clinical safety data in concert with TA Heads to internal project teams and leadership. Provide strategic advice to project teams and senior management on the potential impact of toxicology results on program and clinical/regulatory strategies.

Manage assignments within the Pharmacology and Toxicology function to ensure timely completion of priority activities. Represent preclinical development on discovery and development-stage program teams.

• Delivering quality nonclinical summaries and other high-level regulatory documents for internal decision making and to external health authorities (including but not limited to IND, FDA briefing books, Investigator Brochures, etc.).
• Prioritize and communicate resource allocations and ensure that in vivo pharmacology studies are conducted timely and with highest quality possible.
• Develop resource strategies for execution of book of work by establishing strategic partnerships with CROs, visiting CROs to assess capacity on site and providing oversight to key aspects of studies as needed.
• Support the Therapeutic areas in the development of new animal models and implementation of state-of-the-art research methods as needed.
• Responsible for the operation of the animal care facility, and interactions with attending Vet and IACUC.
• In collaboration with Therapeutic Area leads and outsourcing operations, take responsibility for outsourcing of animal studies at CROs or research institutions.
• Ensure high quality documents for regulatory submissions, publications and timely filing of intellectual property on novel and inventive discoveries.

• Participate in a leadership role at Spark in activities directed towards planning and supporting gene therapy programs towards IND, creation of regulatory documents, regulatory agency interactions as well as assessment of competitor compounds and potential in-licensing opportunities.
• Maintain current knowledge of regulatory guidance, industry standards and recommendations, and stay current on relevant literature and methodologies specific to the non-clinical safety of gene therapy products.
• Participate in development, review and/or presentation of preclinical data internally and externally

Education and Experience Requirements

• PhD in toxicology, pharmacology or related field or DVM with a minimum of 15 years of relevant experience. Board certification in toxicology (DABT) preferred
• 5+ years of related experience leading and managing a team
• 10+ years of experience in technical, scientific, and regulatory aspects of non-clinical safety evaluation of biologics is required; experience with gene therapies is a plus
• Requires a solid understanding of existing and emerging regulatory guidelines in the gene therapy space
• Proven ability to design, manage and interpret non-clinical studies in rodent and non-rodent (NHP) species
• Demonstrated ability to tackle complex scientific problems to enable first in man dosing or progression of programs into late-stage development
• Comprehensive understanding of the interplay between non-clinical safety, pharmacology, biomarkers, DMPK, formulations and process change
• Experience with investigative toxicology including proven ability to research and develop strategy around novel findings
• Extensive experience interfacing with, and providing scientific guidance to CRO partners and proven ability to work efficiently in a hybrid model
• Experience interacting with worldwide regulatory agencies and authoring regulatory filings
• Proven success in supporting cross-functional project teams and ability to collaborate in a cross-functional matrixed organization
• Strong oral communication skills and demonstrated proficiency at technical writing are essential
• Ability to integrate data across disciplines and communicate salient data to executive leadership and/or a broad audience
• Manage the Toxicology and Pharmacology function 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

• Deep expertise of the drug development and approval process and nonclinical study design

• Strong communication skills (written and oral); excellent presentation skills required.

• Capable of representing Spark professionally in the external environment in industry organizations, vendors, regulatory agencies, alliance partners, and others

• Able to effectively engage with toxicology sites and personnel

• Ability to work effectively cross-functionally, and to serve as a resource within Spark

• Ability to mentor and develop staff with regard to preclinical and toxicology issues

• Strong interpersonal and leadership skills required

• Ability to stay abreast of internal and external developments, trends and other dynamics relevant to toxicology in gene therapy to maintain a fully current view and perspective of internal/external influences and/or implications to Spark’s programs

Complexity and Problem Solving

• Self-motivated and detail-oriented with the ability to prioritize and handle multiple projects simultaneously
• Ability to plan and think strategically and critically
• Ability to function as mentor and develop junior staff
• Ability to critically evaluate scientific literature

Internal and External Contacts

This role will interact on a regular basis with a variety of internal and external colleagues, including (but not limited to): Therapeutic Area (TA) Heads, TA leads, Quality Assurance (QA), other functions in Development Sciences, internal clinical, regulatory, medical, safety, R&D, and commercial personnel, external vendors (CROs, labs), toxicology sites, consultants, and global regulators.

Other Job Requirements

Domestic and / or global travel may be required (approximately 30%)

Please be aware that Spark mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law.

Nearest Major Market: Philadelphia

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.