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Medical Lead, Liver-Directed

Employer
Spark Therapeutics
Location
Philadelphia, Pennsylvania. Hybrid and remote options available for select opportunities.
Salary
Salary not provided
Closing date
Jun 7, 2023

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Discipline
Health Sciences, Medicine
Organization Type
Pharma

Job Details

Primary Duties

The Medical Lead will be responsible for directing assigned liver-directed (systemic) gene therapy early phase clinical development programs across Spark. This role will be accountable, working in collaboration with the Development Sub-team Lead, for planning the full clinical trial program to meet the Target Product Profile and regulatory requirements, clinical trial design, execution and completion of studies, publication of study results and preparation of clinical sections of regulatory submissions. S/He/They will also serve as the Medical Monitor on clinical studies and contribute to trial site selection and enrollment, investigator engagement and site training. The Medical Lead will be responsible for clinical guidance in developing liver-directed (systemic) gene therapy platforms within the organization and will serve as a scientific, medical and strategic expert both internally and externally.

Responsibilities

As a key member of the Development SubTeam (DevST), the incumbent will be responsible for implementing the Clinical Development Plan (CDP) for assigned programs to include:

    Collaborating with cross-functional project team members in planning, conducting and evaluating clinical trials for assigned programmes. This includes being responsible for the preparation and review of relevant components of study related documents such as Protocols, Investigator’s Brochure, Clinical Study Reports and Regulatory documents (IND/CTA filings, regulatory document updates [e.g. DSUR, and information requests from Health Authorities]) Serving as Medical Monitor for assigned clinical trials conducting ongoing review of medical/safety data and ensuring correct medical/scientific data interpretation for study reporting Serving as clinical liaison with investigative sites; engage and support clinical trial sites, including education and training. Participate in site selection activities (including feasibility and initiation visits; other site visits as required) and other trial-related activities to achieve enrollment targets and study timelines Serve as internal as clinical expert for global regulatory interactions; collaborate with Regulatory Affairs in planning regulatory strategy and communications Planning and management of investigator meetings, advisory boards and other scientific committees (e.g independent reviews, Joint Monitoring Committees) Analysing and synthesizing clinical data for internal decision making, publication and regulatory filings Acting as a regular reviewer/presenter to various internal committees Maintaining the highest standards and levels of scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment Provide clinical input and work cross-functionally with the Research and Translational Sciences groups 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 gene therapy immune responses Initiate and develop professional relationships with external clinical opinion leaders, investigators, and consultants and stay abreast of competitive intelligence and other market/industry activities 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 Provide clinical expertise to Research, Commercial, Business Development and global teams, as needed Participate in advisory boards, support global initiatives, as needed Attend scientific meetings/present data on their projects, as needed Other duties as assigned or as business needs require.

Education and Experience Requirements

    Board-certified M.D. or M.D./Ph.D. or equivalent qualification with relevant medical experience is required 3 or more years pharma/biotech industry experience OR is a recognized expert in the field of rare diseases, specifically lysosomal storage disorders is preferred Experience of Phase I – II drug development and execution is required. An appreciation for Phase III-IV drug development would be beneficial Multidisciplinary experience in the pharma/biotech industry is strongly preferred (e.g., research, regulatory, clinical operations, business development, commercial operations, etc.) Broad experience in the principles and techniques of data analysis and, interpretation Experience publishing results of interventional clinical trials in peer-reviewed journals is an advantage Experience managing or leading teams is preferred Academic/teaching background is preferred 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 is expected. Global travel required (approximately30%)

Key Skills, Abilities, and Competencies:

    Strong knowledge of the drug development and approval process and clinical trial design Strong communication skills (written and oral); excellent presentation skills required, as well as strong interpersonal and leadership skills 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 more junior staff about clinical and strategic issues Ability to stay abreast of internal and external developments, trends and other dynamics relevant to the work of Clinical Development 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 and clinical trial data

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): other internal clinical, non-clinical, regulatory, medical, safety, R&D, and commercial personnel, external vendors (CROs, labs), investigators and investigative sites, consultants, global key opinion leaders, and global regulators.

#LI-Hybrid

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.

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.


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.

Learn more about Spark Therapeutics and view other openings.

Company

At Spark Therapeutics, a fully integrated, commercial company committed to discovering, developing and delivering gene therapies, we challenge the inevitability of genetic diseases, including blindness, hemophilia, lysosomal storage disorders and neurodegenerative diseases.

Founded in March 2013 as a result of the technology and know-how accumulated over two decades at Children’s Hospital of Philadelphia (CHOP), our investigational therapies have the potential to provide long-lasting effects, dramatically and positively changing the lives of patients with conditions where no, or only palliative, therapies exist. Greater understanding of the human genome and genetic abnormalities have allowed our scientists to tailor investigational therapies to patients suffering from very specific genetic diseases. This approach holds great promise in developing effective treatments to a host of inherited diseases. Our initial focus is on treating orphan diseases.

Headquartered in dynamic Philadelphia, we are a diverse, experienced team united in our goal to break down barriers for people and families affected by genetic diseases. As our name suggests, our investigational, one-time therapies are designed to spark healthy biology, and deliver potentially life-altering transformation for people and families affected by genetic disease. Spark is a member of the Roche Group.

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