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 DRD2 antagonist that is in clinical trials for advanced cancers. The company is currently conducting Phase I/II and Phase II clinical programs in both solid and hematological malignancies with ONC201. In addition, the company has identified additional lead imipridones from its chemical scaffold targeting GPCRs and advancing them toward an IND.

Full-time: VP - Clinical Operations

The VP – Clinical Operations position offers an opportunity to join a 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 our main office in Philadelphia, PA.

Responsibilities:

  • Drive clinical operations activities related to management of clinical studies in accordance with company SOPs, FDA, & ICH guidelines and regulations.
  • Lead clinical operations team, external consultants and all other resources associated within clinical operations
  • Direct CRO’s and vendors and guide supply chain, clinical quality and regulatory operations.
  • Act as liaison between management, clinical sites, and investigators.
  • Develop additional clinical study protocols and oversee amendments of existing protocols
  • Oversee data collection activities for all clinical programs: CRF, SAE assessment, queries, and follow-up, annual reports, investigator brochures, etc.
  • Manage internal tracking mechanisms for clinical programs and ensure achievement of overall annual objectives.
  • Review and QC clinical manuscripts to ensure consistency with EDC.

Requirements:

  • MD, PhD, PharmD, MS, or equivalent with clinical research experience in oncology
  • At least 5 years industry experience in clinical operations management
  • Strong knowledge of FDA regulations and GCP/ICH guidelines regarding clinical trial management
  • Understanding of development requirements in clinical programs (regulatory, medical, etc)
  • Basic understanding of statistical considerations relevant for clinical development programs
  • Excellent computer skills with proficiency in Excel, Word, PowerPoint, and EDCs (e.g. RedCap)
  • Strong writing skills
  • Exceptional interpersonal, communication, and management skills
  • Team player who appreciates clinical development programs as a multidisciplinary task
Full-time: Medical Monitor

The Medical Monitor position offers an opportunity to join a 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 our Philadelphia office.

 Responsibilities:

 Serve as liaison between the Oncoceutics clinical team and clinical sites, communicating regularly with Principal Investigators

  • Assess drug safety information and clinical data
  • Participate in Site Initiation Visits
  • Prepare presentations and manuscripts on clinical research
  • Provide support to other members of the team as needed

 Requirements:

  • MD or equivalent experience with clinical research experience in oncology, preferably neuro-oncology
  • Understanding of the development requirements in clinical programs
  • Basic understanding of statistical considerations relevant for clinical development programs
  • Exceptional interpersonal and communication skills
  • Self-starter that is comfortable working without a lot of day-to-day oversight
  • Team player who appreciates clinical development programs as a multidisciplinary task
Full-time: Clinical Research Associate

The Clinical Research Associate position offers an opportunity to join a 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.

Responsibilities:

Review (remote and on-site monitoring) of appropriate site source documents and medical records

  • Verify required clinical data entered in the case report form (CRF) is accurate and complete
  • Apply query resolution techniques remotely and on site, and provide guidance to site staff as necessary, driving query resolution to closure within agreed timelines
  • Utilize available hardware and software to support the effective conduct of the clinical project data review and capture, i.e. electronic data capture system
  • Verify site compliance with electronic data capture requirements
  • Perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verify the IP has been dispensed and administered to subjects/patients according to the protocol. Verify issues or risks associated with blinded or randomized information related to IP. Apply knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
  • Routinely review the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconcile contents of the ISF with the TMF. Ensure that the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
  • Document activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Support subject/patient recruitment, retention and awareness strategies. Enter data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
  • Data entry, including transcription from source documentation to eDC or other formats.

Requirements:

  • Bachelor’s degree in a science field or RN in a related field or equivalent combination of education, training and experience
  • 5+ years of Clinical Data Management experience
  • Understand ICH and GCP guidelines
  • Knowledge of IRB and Regulatory processes
  • Must demonstrate good computer skills (e.g. pivotal table in Microsoft Excel) and be able to embrace new technologies
  • Excellent communication, presentation and interpersonal skills
  • Ability to manage required travel of up to 50% on an as needed basis
Full-time: Clinical Data Scientist

The Clinical Data Scientist position offers an opportunity to join a group of highly-experienced biotech entrepreneurs in bringing novel cancer drugs through the development process and into the market. Oncoceutics is seeking a highly motivated clinical data scientist to lead clinical data analysis. The successful candidate will have the opportunity to work in a fast-paced and highly collaborative environment to support ongoing clinical development programs across a broad-range range of oncology indications. This is a full time position in Philadelphia, PA.

 Responsibilities:

  • Work with colleagues and collaborators to design and execute data analysis plans, and to summarize the actionable findings
  • Analyze complex clinical data from eDC and other sources, including but not limited to patient demographics, trial accrual, survival, response criteria, pharmacokinetics, adverse event, genomic data, IHC and immune assay data from patient samples
  • Perform regular clinical outcome updates on key indications for ongoing trials
  • Interface in-house tracking systems with eDC system
  • Develop statistical designs for clinical studies
  • Serve as an internal expert on statistics and quantitative data analysis
  • 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 publications

 Requirements:

  • Relevant education in statistics, mathematics, bioinformatics, genomics, computer science or a related field with strong hands-on experience in machine learning, predictive modeling
  • At least 3-5 years of industry experience as clinical data scientist, preferably in oncology
  • Experience in working with large clinical datasets and familiarity with eDC systems
  • Familiarity with oncology is required
  • Proficient in relevant programming languages and analytical software
  • Familiarity with eDC systems (e.g. RedCap)
  • Exceptional written and verbal communication
  • Team player who is highly organized and able to manage multiple concurrent projects
  • Forward-thinking with the ability to anticipate challenges and proactively implement solutions
Full-time: Translational Bioinformatics Scientist

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.

Responsibilities:

  • 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

 Requirements:

  • 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

Please submit cover letter and resume to: careers@oncoceutics.com