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CMO for small/medium size early stage R&D Company
The Chief Medical Officer (CMO) is responsible for developing the company's global product portfolio strategy to bring products to market in compliance with global regulatory, legislative, and medical/health requirements. CMO will oversee the Medical Affairs group, including their field-based team, Medical Information, and Library function. The CMO will act as the primary spokesperson for the company with key opinion leaders at scientific conferences and advisory boards. This global leader of strategist has a detailed operational understanding and functional/operational capabilities to produce current output associated with clinical development, regulatory filings, compliance consistency, safety and pharmacovigilance production, as well as other cross-functional/technical output associated with the overall clinical/medical venue of the company. This CMO is a well-trained medical doctor with doctorate/advanced training in epidemiology, statistics, and scientific development (MD/MD, Ph.D. /M.D. D.Sc.).
Safety, pharmacovigilance, and Surveillance
A trained medical doctor who leads and operates as a component of the safety management teams/operations for clinical/ post-marketing programs.
- Serve as the safety point of contact with other colleagues (RA, QA, Medical Affairs). As a lead medical/global safety officer, as the medical team, leader in global pharmacovigilance, Surveillance, and epidemiology.
- Provide individual case safety review, aggregate reporting, presenting Surveillance, and epidemiology services as a strategist and an individual contributor. Producing regulatory reports and analytical reports, gathering, analyzing and categorizing data, providing initial as well as life cycle clinical/safety/medical analysis and/or overall benefit/risk. Produce ad- hoc reports, liaison with the health authorities as to the point person in global pharmacovigilance. Ample experience in FDA, EMA, CFDA, as well as other H.A.'s including PMDA.
- Create, or assist in creating across all aggregate reporting including but not limited to PBRERs, DSURs, PADERs, signal detection activities, create and/or review safety portions of submission documents, etc.
- Ability to participate in bridging communications between business and safety to ensure appropriate safety context is conveyed. • Solid understanding of regulations impacting Pharma industry in the U.S. and globally, especially drug safety/P.V. This individual contributor as well as clinician lead in safety provides operational, subject matter expertise, as well as technical consultations/strategic consultation in all aspects of global pharmacovigilance and Surveillance.
Clinical Development
This individual is experienced in clinical program management, clinical development strategy, and study design/trial management and reporting, a therapeutic leader. Also, have demonstrated experience with major regulatory submissions (NDA, BLA, MAA). They must be able to lead multi-functional teams and ability to be an effective leader of global teams. This individual possesses detailed knowledge of Good Clinical Practice (GCP) and other regulations governing clinical research. He assures clinical studies are conducted effectively in partnership with Local Operating Company, alliance partners and Clinical Operations colleagues and CRO as appropriate. First clinical study teams in the development and conduct of clinical studies. Lead authoring of study protocols, CRF's and contribute to the development of analytical plans through discussion with matrix team members. Reviews standard format data displays in protocols and CRF's to assure consistency in data capture. He is accountable for authoring of clinical study reports and Investigator Brochures. Assist in producing materials for Investigator meetings. Participate in data review discussions and contribute to data interpretation. He has a clear, proven track record in operating, leading, and produce strategic direction along the entire clinical development process. He is a trained MD, an M.D. scientist (MD, PhD.), or an M.D./public health professional (M.D., MPH).
Medical Writing and Submissions
Prepares, edits, and finalizes protocols, investigator brochures, synopses, regulatory documents, and related clinical documents, such as abstracts, posters, presentations, and manuscripts. These individual partners with the study biostatistician to engage early with the study team including participation in the review of mock and/or blinded tables, figures, and listings (TFLs), and narrative planning for relevant documents. Manages all aspects of outsourced or internal CSR production and ensures project delivery. He ensures that medical writing deliverables conform to International Conference on Harmonization (ICH) and other relevant regulatory guidelines. Creates and maintains standard operating procedure s and work instructions for the preparation and maintenance of compliant medical writing deliverables. Ensures that appropriate documented quality control (Q.C.) checks are performed on medical writing deliverables, responds to findings, and recommends quality process improvements. He is a professional with the ability to produce regulatory as well as medical communication/scientific material. He is a subject matter expert with a clear understanding of a trained MD, Ph.D., or M.D./Ph.D.
Biostatistics
Pharmaceutical biostatisticians ensure that a company's time and money are spent in the most efficient way possible, that animal and human test subjects encounter as few adverse effects as possible, and that medications conform to U.S. Food and Drug Administration (FDA) or other regulations. Biostatisticians use statistical knowledge and industry expertise to figure out the appropriate complexity, size, and duration for testing. They apply the scientific method in predicting and then testing outcomes by collecting, analyzing, and interpreting data on reactions, side effects, and safety. They use statistical software to perform tests such as binomial comparisons, logistic regressions, and longitudinal analyses. They must interpret, summarize, and report the results, explain their findings to other scientists and physicians and educate them on using statistical databases. They also present reports and write journal articles and press releases. This doctorate in biostatistics (Ph.D.) has a clear path and understanding in designing, analyzing, articulating, and creating regulatory documentation as well as collaboration with the clinical, scientific, and regulatory subject matter experts.
Labeling and regulatory
Regulatory Affairs Specialists must understand all aspects of product development, including research, clinical trials, manufacturing practices, regulations, and approval processes. They help review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies. Ensure compliance with regulations. Advise others on regulatory and compliance matters, evaluate applicable laws and regulations to determine the impact on company activities, provide technical review of data or reports, coordinate regulatory documentation activities, identify and interpret relevant regulatory guideline. They must have excellent organizational, analytical, project management, and communication skills. He is trained in writing, I.B., CCDS, USPI, SmPC, etc. He is a technical, clinical, regulatory, and professional medical writer with an advanced degree and health authority background.
Additional functional team members—as more junior levels; including scientists, and associates-- as off- site/On-site staff augmentation may be available. These tasks are across, PV scientists, Clinical development, Medical affairs, Medical Writing, Biopharmaceuticals HEOR associates, Regulatory affairs staff and writers, etc.
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