Samumed is a pharmaceutical platform company based in San Diego, California, focused on
advancing regenerative medicine and oncology applications through research and innovation (www.samumed.com). Samumed has discovered new targets and biological processes in the Wnt pathway, allowing the company to develop small molecule drugs that have the potential to address numerous degenerative conditions as well as many forms of cancer. Samumed is currently conducting clinical trials for five disease areas - osteoarthritis, androgenetic alopecia, oncology, degenerative disc disease and idiopathic pulmonary fibrosis - and has a broad pipeline targeting areas of significant unmet medical need.
The Senior Study & Safety Physician (SSSP) will provide medical expertise, medical responsibility and shared oversight for clinical drug development in Samumed LLC. S/he will participate in the design, conduct, monitoring, data interpretation and reporting of individual clinical studies. S/he will ensure that all clinical studies operate to highest ethical and safety standards in compliance with Good Clinical Practice (GCP) and regulatory requirements. S/he will provide expert clinical input into the clinical, medical and commercial teams working on product development.
This individual will be responsible for providing input used for the design of clinical study concepts and writing of clinical trial protocols, IBs, CSRs, and scientific presentations to the highest scientific standards. S/he will oversee, train and coordinate the primary medical monitors (and be prepared to step in as primary medical monitor when necessary) for all clinical studies. S/he will provide medical review, analysis, and interpretation of data from clinical studies.
Additional responsibility will be to provide primary medical support for the lead of Pharmacovigilance (PV), working closely with this person to ensure that safety reporting is maintained at the highest possible levels of rigor.
Reporting to the CMO, and a member of the senior leadership team, this person will collaborate with various internal (Clinical Project Management, Regulatory, Medical Affairs, R&D, Marketing, Clinical Biostatistics) and external experts or agencies to assist in clinical/ strategy, the development of study designs, scientific publications and product design.
• Medical monitoring and safety: Serve as senior study physician and medical monitor for clinical studies including oversight of primary medical monitors. Responsible and accountable for the analysis of clinical data including safety monitoring with full awareness of clinical trial SAEs. Support PV department with provision of medical opinion and input into all aspects of safety reporting
• Risk Management: Be responsible for the Clinical Safety strategy for drug projects and products throughout all stages of development and/or when on the market, including implementation and communication of the safety strategy at the project team level. Activities include, but are not limited to: definition of identified and potential risks, proposals for mitigation and minimization measures, safety go-no-go criteria for the clinical program, input to TPP/TPC. safety submission strategies, response to regulatory safety queries and definition of risk component of the benefit/risk assessment
• Study oversight: Responsible for protecting the integrity and conduct of clinical studies according to GCP
• Clinical consultation: Provide consultation on protocol design and related questions from internal colleagues or site
• Strategic Consultation: Participate in strategic input to clinical development and commercialization programs and data interpretation
• Subject matter expert: Maintain up to date disease awareness in relevant disease areas through scientific literature, attendance at important meetings and discussion with thought leaders
• Regulatory reports and submissions: Ensure all work is performed to GCP, ICH and regulatory (FDA) standards. Assist with authorship and preparation of regulatory documents (e.g., Briefing Packages, Expert Reports, Special Protocol Assessments). Provides medical input and review of periodic reports (e.g., PBRERs, PSURs, DSURs) and renewal documentation submitted to regulatory agencies. Lead the patient safety contribution to regulatory submissions for new products, formulations or indication
• Communication: Establish and maintain communications with prominent investigators
• Content and presentation: Assist with writing of protocols, IBs, CSRs and scientific presentations. Present this information as required at investigator meetings. This individual will be responsible for the clinical and medical content of all clinical and regulatory documents in collaboration with the medical writing and clinical teams.
• MD Degree: Graduate of recognized school of medicine
• Board Certification
• Five or more years of experience in the practice of a relevant medical specialty at post fellowship level
• 7+ years of industry drug development experience or post fellowship clinical trial experience in an academic institution collaborating with industry sponsors
• Experience in designing, monitoring and implementing clinical trials: Interpreting results, biostatistics, safety reporting and R&D. Experience as a safety physician strongly preferred.
• Good presentation and communication skills
• Lifecycle management: understanding of the intersection between clinical, regulatory and commercial objectives and how these affect product lifecycle planning