Medical Affairs/Safety- Director, Product Lead MD

Location: Cambridge or VirtualTime Zone: EST or CSTWork Arrangement: Hybrid or RemoteContract: 6 months

OverviewFocused on medical review of cases and safety assessment.Expected case volume is approximately 30 35 cases per day, with volume potentially higher depending on workload.

Experience with:

-ICSR medical assessment

-Clinical trials

-Post-marketing cases

-Medical case review

-Signal detection

-Safety/risk assessment

-Regulatory guidelines

-ICH regulations

Summary of Key ResponsibilitiesLead active monitoring and continued assessment of safety profile through systematic signal detection and critical review of aggregate safety data and literature during all phases of the life-cycle of a defined portfolio of products.Be the author and accountable content owner for all safety relevant content or documents during clinical development (e.G. ICF, Risk Language, IB, DSUR, Development RMP) and post approval (e.G. PSUR, RMPs answers to HAs requests). Be content owner for safety relevant communications such as DHCP letters as needed.Be accountable for timely delivery of all safety deliverables towards Clinical Study Reports, preparations for market applications and all other regulatory documents.Provide analysis and presentation of safety data in multidisciplinary teams (e. G. Safety Risk Management Teams).Serve as the safety expert providing strategic input to key stakeholders in relation to product safety, understanding the business strategy for the product, and being knowledgeable about the (medical) context of the respective product class.Collaborate with SRM colleagues to align on a harmonized approach to identifying, evaluating and communicating safety issues.

QualificationsThe ideal candidate will have the following mix of personal and professional characteristics:MD degree with a minimum of 3 years of medical practice is a must.Must have a minimum of 3years of pharmaceutical industry experience as a product/program lead within pharmacovigilanceExperience in clinical research/clinical development is a plus.Knowledge of clinical research methodology, clinical epidemiology/biostatistics, pharmacovigilance tools and processes and relevant regulatory framework is required.Must have sound clinical acumen and a wide range of therapeutic area knowledge.Ability to synthesize and analyze safety data from various sources. Proficiency in problem-solving within a highly complex environment.Excellent communications skills, both written and spoken, ideally with demonstrable experience in medical / scientific writing.Excellent networking and relationship building skills for successful cooperation with internal and external customers.Expertise in international regulations governing drug safety and experience in managing compliance through audits and inspections. Working knowledge of relevant FDA, EU, ICH guidelines, initiatives and regulations governing both Safety reporting and processing for clinical trial environments highly preferred.Excellent interpersonal and decision-making skills. Strong influencing skills with the ability to quickly earn credibility across other functional areas.Ability to work in fast-paced environment with rapidly approaching timelines is important