Medical Director, Clinical Development
Oncolytics is a biotechnology company developing Pelareorep, an intravenously delivered immuno-oncolytic virus. This agent induces selective tumor lysis and promotes an inflamed tumor phenotype - turning "cold" tumors "hot" - through innate and adaptive immune responses to treat a variety of cancers. Pelareorep has demonstrated synergies with immune checkpoint inhibitors as well as additional oncology therapeutic classes and may also be synergistic with other immuno-oncology agents. Oncolytics is currently conducting and planning additional studies in combination with immune checkpoint inhibitors and targeted therapies in solid and hematological malignancies as it prepares for a Phase 3 registration study in metastatic breast cancer. For further information, please visit: www.oncolyticsbiotech.com. Non-con deck link.
Summary: The Medical Director will help execute Oncolytics clinical strategy, including serving as the Medical Monitor for clinical trials being conducted by Oncolytics, and will help to ensure that Oncolytics’ clinical trials comply with good clinical practices and all applicable regulatory requirements. S/He will apply their medical and clinical expertise as a key contributor to the Company’s clinical development strategy.
- Serve as a member of the Global Clinical Development team and contribute to clinical development strategy.
- Co-lead early Phase 1-2 clinical studies moving into Phase 3
- Apply medical/clinical expertise including a sound understanding of disease targets, medical needs, regulatory considerations, and operational constraints in advising on clinical development pathways.
- Contribute to the design and conduct of clinical trials including serving as the Medical Monitor for one or more study(s).
- Ensure the delivery of clinical development activities on time and on budget.
- Present data and conclusions to peers and management.
- Ensure that the clinical sections of regulatory and other documents, including investigator brochures, safety updates, IND/BLA submission documents, responses to Health Authorities, etc., are prepared in an accurate and timely manner.
- Lead/assist the company in accessing external medical expertise including building productive, long term relationships with KOLs and clinical investigators.
- Support partner functions, including Clinical Operations, Regulatory Affairs, Pharmacovigilance, and other teams by providing expert medical and clinical development guidance.
- Provide medical expertise to support business development activities.
- Maintain up-to-date knowledge of developments and competitor activity in medical fields relevant to the company.
- Prepare manuscripts, posters, and other scientific communications, and present at scientific meetings.
- Participate in marketing authorization application planning and execution.
- Participate in the assessment of external vendors, including CROs and CRAs.
- Develop, as required, and ensure compliance with, all SOPs and applicable regulatory standards.
- Perform other duties as assigned from time to time.
- A track record of success in drug development, ideally combining a mix of large biopharma best practices and smaller company adaptability and experience.
- Hands-on, able and willing to do things themselves.
- Medically qualified, preferably with a specialization in oncology
- The ability to analyze data and make strategic decisions.
- Sound understanding of clinical and regulatory pathways for drug development and experience in working successfully with development partners and regulatory authorities.
- Good understanding of the process and requirements for market approval, ideally with hands-on experience as a key team member in taking at least one product through the licensure process.
- Working knowledge of emerging oncology biomarkers.
- Working knowledge of biostatistical approaches commonly utilized in oncology clinical development.
- Excellent communicator with the confidence and professional competence to win respect and gain credibility at all levels within and outside the company; capable of representing the company externally in the scientific and clinical communities.
- A strong external network of KOLs and industry relationships.
- Outstanding organizational skills, project leadership ability, and a self-motivated driver of best practices and processes in clinical development.
- A strong team player, open to challenge and criticism and equally not afraid to speak their mind and challenge others; flexible, practical and pragmatic; proactive and willing to take the initiative; and able to integrate rapidly with a small team in an entrepreneurial environment.
- An MD, preferably a board qualified oncologist; the ideal candidate will have experience in oncology immunotherapies and breast cancer, and GI.
- At least 5 years clinical development experience in biopharma including a demonstrated track record of designing, overseeing, and monitoring clinical trials.
- Global clinical development experience is highly desirable including experience leading complex clinical trials in North America and Europe.
- Experience in interacting with regulatory authorities in the US (and ideally Europe).
- A strong track record of building productive relationships with KOLs and clinical investigators.
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