OncoPep, Inc.: Chief Medical Officer – Part Time

Company Summary: OncoPep Inc, is an early clinical stage biotechnology company focused on developing immunotherapeutics, specifically peptide-based cancer vaccines for the treatment of cancer.

The Company’s lead drug candidate is PVX-410, an HLA restricted, multi-peptide vaccine targeting the tumor associated antigens XBP1, CD138 and CS1 (SLAMF7).

These antigens are highly overexpressed in Multiple Myeloma and several solid tumor cancers (breast, prostate, colon, and pancreatic).

A phase 1b combination study evaluating PVX-410 with and without lenalidomide in the primary clinical target, moderate/high risk for progression smoldering myeloma has been completed.

The data indicated vaccine specific and durable immune response as a monotherapy along with minor clinical responses in the combination arm.

The current clinical development program includes a phase 1b, investigator sponsored study evaluating PVX-410 in combination with citarinostat (an investigational HDAC inhibitor, Celgene, Inc.) for moderate/high risk smoldering myeloma and two on-going, phase 1b investigator sponsored studies evaluating PVX-410 in combination with checkpoint antibodies in adjuvant and metastatic triple negative breast cancer.

In addition, OncoPep has initiated a phase 2 study evaluating the combination of PVX-410 with pembrolizumab and chemotherapy in patients with metastatic Triple Negative Breast Cancer.The Company is building a pipeline of additional immunotherapeutic candidates including an adoptive T cell product for the treatment of hematologic and solid tumors.Job Description Summary: This is a part-time position (approximately 20 hours/week) based in Cambridge, MA, with flexibility to mix work from home and office.

The Chief Medical Officer will report directly to the Chief Executive Officer.

The primary role of the CMO will be to provide leadership and direction for OncoPep’s pipeline of clinical development programs in cancer.

The CMO will be responsible for the strategy, direction and execution of the company’s clinical development plans.

The CMO will also be responsible for building relationships with the medical treatment and academic communities.

The CMO will be a key member of the senior management team which determines and oversees research and drug development at OncoPep and sets the overall strategic direction of the company.

This is a unique opportunity to be a major contributor to the success of a well-positioned, well-financed growth stage biotechnology company.

Essential Duties and Responsibilities: Direct the development of clinical strategies and plans to demonstrate clinical benefit for OncoPep’s investigational drugs leading to a successful registration with the appropriate regulatory authorities.

Develop and manage clinical aspects of regulatory strategies and interactions with Health Authorities Oversee the analysis and interpretation of clinical trial data and the reporting of clinical trial results Lead interactions with academic thought leaders, investigators, cooperative groups, and other clinical stakeholders Provide clinical support and work with other members of the management team to develop and communicate the overall corporate strategy Represent the Company and its programs to external audiences, including the investment, medical and regulatory communities, as well as pharmaceutical or biotechnology industry collaborators/partners In addition to leading and supervising the Clinical Research Team (contractor) the CMO will have direct line responsibility for any internal staff re: Clinical Operations, Patient Advocacy, Medical Affairs, and BiometricsQualifications: The ideal candidate will have: MD with Board Certification in hematology/oncology, solid tumors re: breast cancer would also be helpful 5 years minimum experience in clinical practice treating patients and > 5 years pharmaceutical and/or biotechnology industry experience as a sponsor working on investigational new drugs.

Multiple years of management experience leading a clinical group including clinical/medical affairs and clinical operations A proven success record in Phase I-IV clinical research studies and trial design as well as the successful submission of IND’s and marketing approval-directed filings (BLA’s, NDA’s, and MAA’s) Knowledge, Skills and Abilities: Knowledge of relevant FDA regulations and guidelines as well as those of the EU and other health authorities; experience in interactions with FDA personnel is essential; experience in interactions with other health authorities a plus Experience with immunotherapeutics/ Oncology drug development Experience or knowledge of Orphan diseases a plus Experience in translational medicine, clinical pharmacology and early stage development is desirable Excellent knowledge of the competitive environment for drugs in the Hematology/Triple Negative Breast Cancer/Oncology marketplace and in research and development pipelines Must have a thorough knowledge of clinical research concepts, practices, and GCP and ICH Guidelines.

The successful candidate will read, write and speak fluent English, possess excellent communication skills and will be capable of articulating the Company’s clinical and regulatory strategies and progress to a wide audience including the CEO, the Board of Directors, Company employees, and the investor community.

Must have excellent leadership and interpersonal skills; should have proven skills as an effective team player who can engender credibility and confidence within and outside the company; must have outstanding executive presence.

Must be science and data driven Must be willing to be “hands on”Work Environment: This is a virtual organization which requires the senior team to be independent, highly communicative, flexible, hands on and willing to tackle multi-disciplinary challenges.

Willingness and ability to travel domestically and internationally is required, it is anticipated that this will be 30 % of work time.

Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The above job description is not intended to be an all-inclusive list of duties and standards of the position.

Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor.EEO & EMPLOYMENT ELIGIBILITYOncoPep is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

OncoPep also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of applicable law.