Oncoceutics, Inc. is a clinical-stage drug discovery and development company with a novel class of small molecules called imipridones that selectively target G protein-coupled receptors for oncology. The first lead compound to result from this program is ONC201, an orally active antagonist of GPCR DRD2 that is well-tolerated and effective against advanced cancers. The company is currently conducting advanced Phase II clinical programs in both solid and hematological malignancies with ONC201. A specific form of pediatric and adult high-grade gliomas, called H3 K27M mutant gliomas is the lead indication for regulatory approval of ONC201 that is being targeted in the United States. In addition, the company is introducing its second imipridone into the clinic, ONC206, for neuro-oncology indications and is further characterizing the ability of additional imipridones to target GPCRs for oncology.
The Manager/Associate Director, Clinical Data Managementposition offers an opportunity to join a small group of highly-experienced biotech entrepreneurs in bringing novel cancer drugs through the development process and into the market. This is a full-time position at the University City Science Center, Philadelphia, PA.
- Develop clinical data management plans including key study documents (e.g. Data Management Plans, Case Report Forms, data transfer specifications, SAE and/or external data reconciliation plans, coding conventions, study protocols, UAT execution) for multiple clinical trials, including both company-sponsored and investigator-initiated studies
- Oversight of data management CRO/service providers on assigned studies
- Monitor the progress of all data management activities on assigned studies to ensure project timelines are met.
- Provides training on the CRF completion guidelines and EDC system at Initiation Visits and to internal or external team members, as needed.
- Serve as main point of contact with clinical sites for data-management related matters
- Proactively identifie potential study issues/risks and recommends/implements solutions
- Responsible for the accuracy and completeness of the clinical data collected during a clinical trial, able to work independently towards the assigned goals
- Provide Data Management support to Statisticians and Statistical Programmers in production of clinical trial reports and other deliverables
- Track and provide status updates on data management at regular team meetings
- QC review of clinical manuscripts, regulatory documents, and clinical protocols/ICF to ensure consistency with current clinical database
- Establish systems and procedures required for a typical FDA audit on clinical programs
- Bachelor’s degree, preferably in a science-related field
- At least eight years of clinical data management experience with a preference for oncology trials and familiarity with both industry-sponsored and investigator-initiated trials
- Demonstrated experience with developing data capture and management systems for new clinical trials (designing CRFs/eCRFs, edit checks, CRF completion guidelines, etc.) in a Pharmaceutical/Biotech/CRO environment.
- Knowledge of industry standards (CDISC, SDTM, CDASH)
- Strong technical skills in various EDC systems, plus MS Word, Excel, PowerPoint, etc.
- Forward-thinking with the ability to anticipate challenges and proactively implement solutions
- Strong attention to detail with exceptional written and verbal communication
- Team player who is highly organized and efficient and can operate without the support of a team typical in large pharma
The Translational Bioinformatics Scientist position offers an opportunity to join a small group of highly-experienced biotech entrepreneurs in bringing novel cancer drugs through the development process and into the market. We seek a creative and collaborative scientist to apply novel methods of data integration of multimodal profiling data to enable translational research for drug discovery and development. The successful candidate will work to solve important challenges in translational research by mining complex data to drive biological/clinical insights. The scientist will play a key role in an interdisciplinary team of translational researchers/clinicians. This is a full-time position in Philadelphia, PA.
- Identification of candidate indications by combining internal mechanistic rationale with analysis of publicly available datasets (genetic, clinical and other)
- Identification of novel biomarkers based on internal preclinical and clinical datasets
- Support predictive/pharmacodynamic biomarker assay development based on preclinical data and incorporation into clinical trials
- Develop SAR algorithm based on internal chemical scaffold and target discovery datasets for identification of new preclinical drug candidates
- Assist in managing computational, mechanism of action, safety, chemistry and efficacy studies to enable clinical introduction of novel small molecule therapeutics
- Create presentations for internal communications and external presentations to scientific and investor audiences
- Participate in drafting of grant applications to support preclinical and clinical development
- Prepare conference abstracts and manuscripts for publication
- PhD in bioinformatics or computational biology or related fields
- At least 3-5 years of relevant bioinformatics/genomics experience, preferably in oncology and/or pharmacology
- Deep understanding of genomics and molecular biology (cancer genomics preferred)
- Experience in analyzing large sequencing datasets (e.g. RNA-seq)
- Combine analytic skills and an understanding of biological sciences with computational techniques/statistics.
- Experience in GPCR biology or neuro-oncology preferred, but not required
- Post-doctoral and/or industry experience preferred, but not required
- Demonstrated experience with scientific evaluation of therapeutics and/or biomarkers; drug development experience not required
- Strong publication record as first author
- Exceptional written and verbal communication
- Team player who is highly organized and able to manage multiple concurrent projects with minimal oversight
- Forward-thinking with the ability to anticipate challenges and proactively implement solutions
The Business Development and Finance Associate position offers an opportunity to join a small group of highly-experienced biotech entrepreneurs in bringing novel cancer drugs through the development process and into the market.
- Work with the VP of Finance and BD, COO, and CEO to contribute to the development of the global business development strategy, development and execution
- Work cross-functionally to identify, engage, and manage relationships with potential strategic partners and investors
- Manage existing research and development partnerships with strategic partners and academic institutions to strengthen Oncoceutics imipridone portfolio
- Develop relationships with contacts across biotech, pharma and healthcare investment and utilize appropriate tools to enable reporting of BD activities
- Develop high quality marketing presentations and financial projections
- Work with external legal counsel on documentation in support of funding and partnerships
- Manage grant applications including development, submission, and reporting
- Support Oncoceutics in improving operational organization and sophistication
- Provide support to other members of the team as needed
- Scientific or business educational background including at least a Bachelor’s degree in business, economics, or biology
- Evidence of a strong business and science background
- General knowledge of oncology and drug development that provides a foundation to quickly learn and communicate complex scientific concepts
- Advanced proficiency in Excel, Word and PowerPoint
- Strong writing skills
- Exceptional interpersonal and communication skills
- Autonomous and self-motivated thinker comfortable working without a lot of day-to-day oversight
- This is a full-time position located either in our headquarters in the University City Science Center or in our New York City office
The Clinical Research Associate position offers an opportunity to join a small group of highly experienced biotech entrepreneurs in bringing novel cancer drugs through the development process and into the market. This is a full-time position at the University City Science Center, Philadelphia, PA.
- Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.
- Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
- Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
- Gains an in-depth understanding of the study protocol and related procedures.
- Coordinates & manages various tasks in collaboration with other sponsor roles to allow site activation.
- Participates & provides inputs on site selection and validation activities.
- Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits. Completes comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
- Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.
- Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
- Identifies, assesses and resolves site performance, quality or compliance problems and escalates to Clinical Project Manager.
- Manages and maintains information and documentation in Trial Master File, and various other systems as appropriate and per timelines.
- Contributes to CRA team knowledge by acting as process expert, sharing best practices as appropriate/required.
- Supports and/or leads audit/inspection activities as needed.
- Performs remote and on-site monitoring & oversight activities using to ensure: 1) Data generated at site are complete, accurate and unbiased and 2) Subjects’ right, safety and well-being are protected.
- A./B.S. preferred with strong emphasis in science and/or biology
- 2 years of direct site monitoring experience in a bio/pharma/CRO
- Ability to travel domestically approximately 65%-75% of working time
- Expected travelling ~2-3 days/week