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.

Full-time: Senior Director of Regulatory Affairs

The Senior Director of Regulatory Affairs 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 colleague to provide strategic and operational leadership to cross-functional teams for the development of our imipridone platform, with a focus on NDA preparations for our lead molecule ONC201 and expanding its development beyond the United States. The Senior Director of Regulatory Affairs in collaboration with senior management will function as leader of the drug development team and will coordinate the development and execution of an integrated, global regulatory strategic plan for Oncoceutics’ development programs. The Senior Director of Regulatory Affairs conducts and/or oversees regulatory authority interactions as required to support key program milestones from preclinical development through marketing authorization in target regions and countries. The position is responsible for updating teams on new developments in the areas of competition, regulatory policy/ guidance, review and/or compliance.

The Senior Director of Regulatory Affairs will play a key role in an interdisciplinary team of translational researchers/clinicians. The position offers a unique opportunity to take a late stage Phase II drug candidate to an NDA by focusing on the regulatory strategy for ONC201.

This is a full-time position in Philadelphia, PA.

Responsibilities:

  • Lead aspects of regulatory strategy development and execution including working with team members to complete submissions relevant to assigned projects and programs
  • Provide guidance on regulatory requirements for expanding distribution of investigational agents outside of the United States
  • Provide guidance on content and provide review and approval of regulatory submissions including Request for Designation, Meeting Background Packages, Clinical Trial Applications, and Marketing Applications;
  • Participate with the regulatory leads in the preparation and maintenance of our clinical trials, e.g. Investigational New Drug (IND) and Investigational Medicinal Product Dossiers (IMPDs), as well as, preparation and maintenance of product authorization applications, e.g. NDA, MAA, as applicable.
  • Monitor applications under regulatory review; communicate application progress.
  • Preparation of responses to questions issued by Regulatory Authorities/ Agencies.
  • Participate with regulatory leads in preparation, submission and follow-up of Orphan Drug Applications, Pediatric Study Plans, Pediatric Investigational Plans, etc.
  • Report adverse events to regulatory agencies and internal stakeholders.
  • Support the preparation, review, and approval of compliant regulatory documents throughout the product lifecycle. Work effectively with regulatory colleagues specializing in other functional areas to continuously improve regulatory systems, teamwork, and efficiency.

Requirements:

Bachelor’s or Master’s degree in life/health sciences required.

  • Minimum of ten (10) year’s experience in pharmaceutical sector with Regulatory Affairs;
  • Experience in development of new chemical entity through NDA;
  • Comprehensive knowledge of applicable regulations, including GCPs, GMPs and GLPs;
  • Global International regulatory experience
  • Experience in oncology preferred.
  • 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.
Full-time: Scientific Director, Clinical Pharmacology

The Scientific Director, Clinical Pharmacology position offers an opportunity to join a small group of experienced biotech entrepreneurs in bringing novel cancer drugs through the development process and into the market. We seek a creative and collaborative colleague to apply and promote clinical pharmacology knowledge, including pharmacokinetics/ pharmacodynamics analyses and principles of small molecule drug development in the imipridone program, with a focus on NDA preparations for our lead molecule ONC201. The Scientific Director, Clinical Pharmacology in collaboration with the Chief Development Officer and SVP of Research and Development will function as the manager of NDA-enabling clinical pharmacology programs.

The Scientific Director will play a key role in an interdisciplinary team of translational researchers/clinicians. The position offers a unique opportunity to take a late stage Phase II drug candidate to an NDA by focusing on how imipridones interact with biological systems or diseases to perform as safe and effective cancer treatments. You will contribute to the overall drug development by applying quantitative methods to integrate your knowledge of PK/PD, clinical data from our trials and preclinical results.

This is a full-time position in Philadelphia, PA.

Responsibilities:

  • Collaborate with consultants, colleagues and executive team on modeling and simulation activities in drug development programs. Perform and/or liaise for modeling and simulation analysis of preclinical-clinical data, translational PK/PD data, and clinical trial results.
  • Collaborate with stakeholders on the execution of scientifically robust and efficient clinical pharmacology strategies for the NDA path of ONC201 and earlier strategies for additional development candidates.
  • Applies the understanding of a) the impact of intra- and inter-subject variability in physiology and/or pathology, concomitant medication use, and biopharmaceutics, on pharmacokinetics (PK) and PK/pharmacodynamics (PD) across the imipridone platform, and b) requirements for the clinical pharmacology regulatory submission packages and submission processes for ONC201.
  • Carries out operational and strategic responsibilities in accordance to applicable SOPs and regulatory requirements.

Requirements:

  • MS or PhD in Clinical Pharmacology, Biomedical Engineering, or relevant Sciences with a minimum of ten (10) years of relevant experience.
  • Experience in development of new chemical entity through NDA.
  • Deep understanding of PK/PD and practical experience with translational medicine.
  • Understanding of drug development and the overall pharmaceutical R&D process is required.
  • Drug development experience in small molecule therapeutic areas and the ability to manage multiple pharmacology programs is required.
  • Experience in oncology preferred.
  • Working knowledge of clinical and regulatory landscape, oncology and patient populations required.
  • 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.
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