The following positions are currently available at Oncoceutics. To apply, please send a resume and cover letter to email@example.com with the title of the position in the subject line.
The Senior Clinical Data Manager 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.
- Develop a clinical data management plan that includes systems and procedures for multiple clinical trials, including both company-sponsored and investigator-initiated studies
- Serve as main point of contact with clinical sites for data-management related matters
- Execute all data management activities, including the development and maintenance of:
- CRFs/eCRFs, including guidelines
- Lead SIV training of site staff to use eDC of choice
- Adverse event reporting (from site to sponsor and from sponsor to regulatory agencies)
- Perform QC/QA review of clinical data on a rolling basis
- 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 five 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.)
- 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 Associate Medical Director 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.
• Work directly with the CEO, who is primarily responsible for all clinical programs, and our clinical sites, communicating regularly with Principal Investigators
• Monitoring all clinical programs to ensure achievement of overall annual objectives
• Establish validated databases that consolidate critical clinical data from all clinical studies (including investigator-initiated studies) and that meet regulatory requirements
• Develop additional clinical study protocols and oversee amendments of existing protocols
• Review and QC clinical manuscripts to ensure a match with databases
• Establish systems and procedures required for a typical FDA audit on clinical programs
• Coordinate with the CBO to negotiate CTAs and other agreements required to conduct the clinical studies with individual sites
• Attend team meetings and contribute to critical decision making processes as a member of senior management
• MD degree with clinical research experience, preferably in oncology
• Understanding of the development requirements for clinical programs
• Basic understanding of statistical considerations relevant for clinical development programs
• Excellent writing skills
• Strong computer skills with proficiency in Excel, Word and PowerPoint
• 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
Oncoceutics may make internship positions available for highly qualified individuals. An Intern for Business Development would work with the Chief Operating Officer and the Associate for Finance and Business Development on a variety of projects related developing commercial partnerships to further the development of Oncoceutics’ family of compounds.
- 10-12 week summer internship that provides the opportunity to begin building an introductory knowledge base in the field of drug development and life science venture capital.
- Work to develop an understanding of the competitive landscape and potential paths to market for specific disease areas.
- Maintain, enhance, and analyze the company’s proprietary database of commercial transactions in oncology.
- Identify and engage with companies and academic groups that could be potential partners for Oncoceutics.
- Identify and engage with potential funding sources for Oncoceutics, including venture capital firms, governmental and private granting organizations, and disease focused foundations.
- Participate in team meetings and gain exposure to all areas of drug development including clinical trials, preclinical research, regulatory activities, and intellectual property
- Undergraduate student with an interest in the business of science. An ideal candidate will have course work and/or other experience in both finance and biology
- Strong record of academic achievement.
- Excellent computer skills with proficiency in Excel, Word and PowerPoint.
- Strong writing skills.
- Some familiarity with the generation of financial statements and projections.
- Exceptional interpersonal and communication skills.
- Self-starter that is comfortable working without a lot of day-to-day oversight.