Cambridge, MA/ remote
cc- Drug Safety Physician
6 months ago
A leading precision oncology company enabled by its proprietary approach to the discovery and development of novel therapeutics. The company utilizes its genome-wide, enabled platform to systematically discover and develop highly targeted cancer therapies focused on genomic instability, including DNA damage repair. The company’s pipeline includes its lead product candidate, a potential leading ATR inhibitor, as well as a 2 more inhibitor programs
This company is growing at a rapid pace with challenging and exciting opportunities for experienced professionals. They are looking for scientific and business professionals who are highly motivated, collaborative and, above all, share our passionate interest in fighting cancer and improving patients’ lives.
They are currently seeking a Medical Director/Medical Safety Physician. The Medical Director/Medical Safety Physician is independently responsible for the proactive safety strategy and all medical safety aspects of pharmacovigilance and medical risk management for clinical development programs and studies.
You will, in close collaboration with the CMO partner and the Clinical Team, monitor and manage the ongoing safety profile of assets in clinical development to maximize the understanding of risks and benefits for prescribers, patients, consumers and study subjects through proactive review of all relevant pre- and eventual post- marketing safety data, medical analysis and decision making.
Activities include the oversight of safety aspects for clinical studies, development and maintenance of the Company Core Safety Information, development of ad hoc aggregate safety reports, contribution to and review of aggregate safety reports, development and conduct of signal detection activities and reports, safety sections of risk management plans, and review of field alert reports as appropriate, the assessment on patient impact for the health hazard evaluation (HHE).
Determine and advise the course of action necessary to meet the safety goals and objectives of specific products and projects.
Collaborates with cross-functional teams and counterparts in regulatory labeling, clinical development, pre-clinical, manufacturing/quality, epidemiology, and other functional areas to identify, evaluate, and communicate safety issues.
Represents the organization in outside discussions, medical-scientific forums, at regulatory agency meetings, symposia and trade associations and establishes and maintains a strong network within the Pharmaceutical industry.
Conduct work activities in compliance with all relevant global regulations and guidelines as well as all company policies, and procedures. This organizations policies include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.
Key Responsibilities include but are not limited to:
- Collaborates on authoring safety specification section of RMP and REMS documents and updates. Review and approve RMPs and REMS. In collaboration with relevant stakeholders evaluates effectiveness of risk minimization actions. Prepare safety statements for safety relevant communication purposes such as Dear HCP letters. Support product acquisitions, due diligence, legal issues and recalls, as appropriate.
- Lead safety reviews and signal detection of assigned pre- marketed products. Make data-driven decisions and write safety review documents and reports.
- Participate in the preparation, review, approval, and distribution of the Development and Company Core Safety Information for inclusion in IBs, Company Core Data Sheets and local labeling. Update pre-marketing and eventual post-marketing safety information and provide the justification documentation for any changes to IBs.
- Be responsible for safety aspects of clinical trials including drafting and review of relevant safety chapters/text of key clinical trial documents such as informed consent, protocols (specifically inclusion / exclusion criteria and AEs of interest). Evaluate all safety data generated in clinical trials. Participate in global teams to provide medical safety leadership and development of risk management strategy. Liaise with assigned Data Safety Monitoring Boards. Respond to safety questions from investigator sites and IRBs regarding safety issues and queries. Provide medical safety interpretation of safety findings for all clinical study reports, including final review of safety relevant adverse event coding for assigned projects and discuss, propose, and communicate any revision(s) or additions. Ensure regulatory reports (e.g., clinical study reports, NDA, BLA) accurately reflect proper safety interpretation of the clinical study findings. Lead, author and own relevant sections of the development of clinical investigator brochures, integrated summaries of safety, risk/benefit assessments, clinical expert reports, and other relevant safety sections or documents in support of regulatory submissions and annual periodic or update reports. Lead safety response to health authority assessor questions after filing and response to Health Authority inquiries on clinical studies, when necessary.
- Author relevant safety sections of aggregate reports (PSUR, PBRER and DSUR) and conclusions of product safety profile for these aggregate reports. Review and approve the aggregate reports. Contribute safety sections and risk/benefit assessment, if required, to Annual Safety Reports / IND annual reports. Review to ensure regulatory reports accurately reflect proper interpretation of findings. Assist in the preparation of safety sections and review of regulatory documents.
- Develop and maintain comprehensive and current knowledge (e.g., indications, labeling documents, pharmacology, etc.) of the product portfolio and current regulations governing the processing and reporting of safety data,
- Develop inspection readiness for medical assessment activities and supports regulatory authority inspections when required. Represent the organization in outside discussions, medical-scientific forums, at regulatory agency meetings, symposia and trade associations and aims to establish and maintain a strong network within the Pharmaceutical industry. Liaise with internal and external experts / Key Opinion Leaders to obtain specialized medical expertise appropriate. #LI-PD1
- M.D. or equivalent
- Specialized clinical experience in Oncology
- At least 8-10 years of experience in risk management and pharmacovigilance (safety signal detection, data mining techniques, pharmacovigilance databases, etc.)
- At least 5 years of experience in safety monitoring in clinical trials
- Proven track record of successful management of product safety matters (global submission, labeling negotiation, regulatory inspection, etc.)
- Experience in the clinical and drug development process in a global pharmaceutical/biotechnology company and preparation risk management plans, aggregate reports and company core safety information highly desirable