Medical Lead, Liver/Internal Medicine

Primary Duties:

The Medical Lead will be responsible for directing the liver-platform/internal medicine early phase clinical development programs across Spark. This role will be accountable for planning the full trial program to meet the target product profile and regulatory requirements, clinical trial design, execution and completion of the study, publication of study results and preparation of clinical sections of regulatory submissions. In addition, the Medical Lead is responsible for leading the activities he/she is assigned to but may also assist with other clinical development programs in other therapy areas. The Medical Lead will also contribute clinical guidance in developing liver-directed gene therapy platforms within the organization.

Responsibilities:

Responsible for implementing the Clinical Development Plan (CDP) for assigned programs Keeps current in internal and external developments, trends and other dynamics relevant to the programs they are leading to maintain a current view and perspective of internal/external influences and/or implications for the assigned therapeutic and disease area(s) Maintains the highest standards and levels of scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment May lead clinical and/or disease strategy development, collaborating with a variety of internal and external partners and stakeholders, such as clinical investigators, scientists and key opinion leaders, as well as multidisciplinary internal groups, including other group such as research, clinical operations, drug safety, regulatory, portfolio management, business development, market planning, legal, etc., and may present to various internal committees Participates in competitive intelligence and/or other market/industry assessment activities and projects as appropriate Provide clinical input and work cross-functionally with the Research and Development organizations to help develop optimal strategies for managing liver-directed gene therapy immune responses Work with external experts and organize forums to help inform strategies for mitigating liver-directed immune responses Provide input to Medical Affairs regarding global publication and launch plans and participate in development of materials (slide decks, posters, manuscripts, abstracts), based on clinical trial data for their projects Participate in development, review and/or presentation of clinical data in Training, Managed Care, or other presentations for their projects, as needed Provide clinical expertise to commercial and global teams, as needed. Participate in advisory boards, support global initiatives; developing target product profiles, attend scientific meetings/present data on their projects, as needed Drives and integrates ongoing evidence/data generation, including clinical trials, Medical Affairs studies, Real World Evidence, and other types of evidence.

• Other duties as assigned or as business needs require.

Education and Experience Requirements:

Board-certified M.D. or M.D./Ph.D. is preferred Experience in any relevant medical field with a preference for hepatology 6 or more years of pharma/biotech industry experience OR equivalent field. Comprehensive understanding of Phase I – II drug development is required, with a preference for also understanding Phase III-IV drug development Proven success designing and executing clinical trials is desirable Experience managing medical/clinical staff is strongly preferred Academic/teaching background is preferred Experience conducting basic/translational studies is preferred Comprehensive understanding of product and safety profiles Working knowledge of medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE and other relevant guidelines and regulations

Opportunity to manage a team in the future 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 clinical trial design Strong communication skills (written and oral); excellent presentation skills required. Capable of representing Spark professionally with external global opinion leaders, investigators, vendors, regulatory agencies, alliance partners, and others Able to effectively engage with investigative sites and personnel Ability to work effectively cross-functionally, and to serve as a clinical resource within Spark Ability to mentor and develop staff with regard to clinical and strategic issues Strong interpersonal and leadership skills required Ability to stay abreast of internal and external developments, trends and other dynamics relevant to the work of CD to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for the assigned therapeutic and disease areas

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 critically evaluate scientific literature

#LI-2326

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.