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
View more
- Discipline
- Health Sciences, Medicine
- Organization Type
- Pharma
Job Details
-
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.
-
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%)
-
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
-
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
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.
- Website
- http://sparktx.com/
Get job alerts
Create a job alert and receive personalized job recommendations straight to your inbox.
Create alert