Department: Clinical Development & Medical Affairs (CDMA)
Reporting to the VP of Clinical Development and Medical Affairs, the Medical Director will be responsible for assisting in implementation of the Oncolys USA drug development strategy and will lead all aspects of individual drug programs. He or she will provide clinical input on clinical protocol development, regulatory issues, and patient enrollment to clinical studies, safety monitoring and review, biomarker development, implementation and analysis of data, manuscript writing and submission, as well as presentation of data at national and international meetings. This position will have a strong outward facing presence and will support investigator-initiated trials and assist in the protocol review, site evaluation and selection process for clinical trials. The role functions internally as a medical expert/monitor to support the development and execution of an efficient and integrated global medical/scientific strategy, including scientific evidence generation and scientific information exchange with key stakeholders.
The Medical Director /Sr. Medical Director is preferably a board-certified physician. The ideal candidate will have history of clinical research or some industry experience in the Oncology therapeutic area. The Medical Director is knowledgeable of the actions of regulatory bodies, in particular the FDA, and has experience in all aspects of clinical trials. The ideal candidate should have significant experience in their medical specialty and would thrive on proactively engaging internal and external leaders and will serve as a medical expert for their compound(s) and/or disease area. He or she will have strong commercial aptitude and/or experience, including proven ability to translate and appropriately align commercial and scientific goals and objectives. S/he will have solid peer relationships with external scientific and clinical experts in Oncology. The individual must have the ability to work independently and also as an effective and engaged team member in a fast-paced environment. Strong initiative and follow through are essential for this job. The ability to maintain confidentiality and to operate in the role with the highest of ethical standards and professionalism are required.
- Help cultivate and advance a clinical development strategy and integrated development plan for Oncolys oncology program, design, biomarker and implementation of Phase I-III clinical studies in the immuno-oncology space.
- Closely interface with VP CD & MA, Clinical Operations and early development groups in Tokyo to define opportunities to explore new areas of scientific discovery
- Support R&D management and the business development team with input on clinical development issues related to their BD plan, and support the business development process by providing medical expertise for in- or out-licensing, partnering and acquisition activities;
- Be responsible for the clinical content of all clinical and regulatory documents, including protocols, INDs, CTAs, investigator brochures, CRF’s, annual IND reports, CSR’s, ISS’s, ISE’s, and clinical expert reports;
- Lead and supervise clinical trials/registries, collaborating closely with the Clinical Operations team, and will be accountable for all deliverables of clinical trials under his/her direct responsibility;
- Serve as Medical Monitor and the Sponsor’s medical representative to multiple vendors and collaborators; CROs, PIs, core laboratories and other organizations involved in the implementation of clinical trials
- Be responsible for analysis of clinical data, including safety monitoring in collaboration with PV, and implement appropriate pharmacovigilance actions, if necessary.
- Develop and maintain relationships and serve as the main medical liaison with key opinion leaders and PIs
- Organize and present at relevant clinical advisory boards and medical/scientific meetings as needed.
- Advises VP CD&MA on critical issues deserving immediate attention and escalation, proposing actionable solutions. Acts as an independent and reliable resource to Oncolys BioPharma R&D team, assisting in driving strategy and execution Interact with consultants, clinical pharmacologists, clinical investigators, and affiliate CRPs to plan, initiate, and conduct global clinical trials.
- Develop and/or review clinical trial protocols and serve as medical lead for trial conduct.
- Assist in the review of Investigator-Initiated studies and in the identification of clinical sites
- Prepare and present documentation of clinical trial results to corporate committees, regulatory agencies, and outside audiences, and publish results of research projects.
- Establish and maintain contact with external experts , opinion leaders and strategic partners in academia, government and industry to advance Oncolys’s Image
- Supply medical input into safety profile of the product and work with VP of CDMA and commercial teams to provide scientific and clinical expertise/input into strategic and tactical decisions in support of Oncolys BioPharma products acting as medical expert for disease area.
- Ensure that all clinical programs are in compliance with all applicable regulations
- Helps with review and analysis of patient safety data and implement any protocol changes mandated by safety concerns
- Help ensure Clinical Study Team compliance with FDA, EMEA, ICH and GCP guidelines and internal SOPs;
- Contribute to scientific and clinical communications
- Monitor global scientific/medical literature.
- Provide medical insight into Advisory Board meetings, learning materials for internal and external use
- Assist in the development of publication plan for Oncolys Oncology products in development
- Complete scientific reports, manuscripts and other educational materials
- Work with investigators to identify publication and abstract opportunities
- Help to identify opportunities for data presentation and Oncolys representation at national and international meetings and conferences
- Provide oversight for internal review of manuscripts and data presentations
- Contribute to business development efforts.
- Participate, as requested, as clinical expert on due diligence teams related to external in-licensing opportunities
- Partner with the business development team to evaluate novel targets and platforms in the immuno-oncology space
- M.D with board certification/eligibility in Oncology or Hematology/Oncology or comparable training
Experience and skill requirement:
- 2-5+ years of relevant clinical research experience in clinical development and/or medical affairs Experience in the biopharmaceutical industry preferred; substantial experience working on industry-sponsored trials with Immunotherapy ( I.e- CPIs) will be considered with
- Thorough understanding of Phase I-III drug development with proven ability to plan clinical trials, deliver high quality results within established timelines, interpret, analyze and communicate clinical/scientific data, and generate clinical/scientific documents.
- A demonstrated track record of success in your field, the capacity to lead with minimal supervision, plan strategically, achieve goals on time, and communicate effectively.
- Excellent written and verbal communication skills to meet the needs of varied audiences.
- Strong interpersonal skills commensurate with the need to work closely with partners, investigators, contractors, consultants, and team members across functions.
- Knowledge of FDA/EMA requirements, good clinical practices and pharmaceutical clinical development.
- Excellent analytical, problem-solving and strategic planning skills.
- Well organized with strong management, leadership, mentoring and motivational skills.
- Ability to work independently and thrive in a fast-paced environment.
- Attention to detail, demand for high-quality work, and sense of passion and urgency to achieve goals and improve the lives of patients.
- Strong business acumen, including working knowledge of changing U.S. payer and provider
- Strong interpersonal, influencing, presentation, and communications skills (written and verbal) to effectively address all levels within an organization
- Excellence in solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues.
- A team player; able to collaborate successfully with both internal and external colleagues.
- Excellent communication skills both written and oral, including strong presentation skills.
- The highest personal integrity; committed to ethics and scientific standards.
- High energy and absolute commitment to culture
- Strong analytical skills, comfort managing through ambiguity.
- Understanding and success in dealing with different cultures.
- Ability to manage competing priorities and projects, requiring an excellent ability to prioritize and manage expectations.
- A “lifelong” learner who consistently seeks opportunities to learn.