Senior Director of Drug Safety/Pharmacovigilance - Gene Therapy Start Up Organisation

Orchard Therapeutics
London (Greater)
26 Sep 2017
03 Nov 2017
Contract Type
Full Time
This is a unique opportunity to join a clinical-stage start up biotech company focused on developing life-transforming therapeutics for patients with rare diseases. looking for an experienced medical leader with the passion and creativity to develop great medicines for rare diseases. Reporting to the CMO, the Senior Medical Director, Drug Safety will be responsible for the strategic global implementation, execution, and management of Pharmacovigilance and risk management activities in conjunction with the Company’s development and commercial activities, industry standards, and compliance with global regulations. This person must effectively collaborate cross-functionally at all levels in the organization as well as external regulatory authorities. They will be accountable, lead and provide medical oversight for the pharmacovigilance, drug safety and risk management functions for investigational and marketed products, ensuring proactive and timely risk-benefit assessments of safety data. This position will also be a member of the Development Leadership Team and will help define the short and long term portfolio strategy for the company. This individual should be a self-starter with excellent leadership and management capabilities who is seeking to be part of an innovative team to support the company’s drug development activities. We expect this individual to be able to help setting up the infrastructure for PV within orchard Responsibilities · Oversees and directs all aspects of pharmacovigilance and risk management activities for investigational compounds and marketed products; actively participates in oversight of patient safety in all clinical trials · Designs, directs and conducts ongoing safety surveillance of company drug products using internal and external resources (CROs) to ensure delivery of high-quality pharmacovigilance services · Negotiates contracts, interacts and supervises the activities of CROs and consultants for pharmacovigilance services. Provides ongoing updates to senior management on the changing risk-benefit profile of company drug products in clinical trials, based on analyses/evaluation of potential safety signals and implements appropriate safety updates and risk mitigation plans · Provides strategic planning, implementation, and management of drug safety activities to support clinical development of company products · Provides oversight of all clinical safety activities including review of medical coding of AEs, con-meds, and processing of SAEs through the entire lifecycle including preparation of analyses of similar events (ASE) for unexpected and related serious adverse events (SUSARs) from clinical trials · Lead role to respond and resolve safety questions from regulatory authorities, as well as regulatory agency audits and inspections, and corrective action plans. · Directs the development, preparation and compliance of periodic and annual safety reports (e.g., DSUR, PSUR, periodic line listings, NDA safety updates, etc...), investigator communications, product labeling/package inserts and other reports as necessary · Provides medical expert safety review input into all critical documents for clinical development of products (e.g., protocols and amendments, ICFs, IBs, IMPDs, clinical research reports, INDs, CTAs) · Ensures departmental budgets and schedules meet corporate requirements · Manage internal staff and external contractors to ensure delivery of quality safety and pharmacovigilance services, including selecting, developing, training, and evaluating team to ensure the efficient operation of the drug safety function · Monitors industry best practices and changes in global safety regulations and guidelines. Writes and put in place departmental policies, SOPs and systems to ensure global regulatory compliance Job Requirements · Extensive management experience in pharmaceutical drug safety including a thorough understanding of case processing and other pharmacovigilance processes · Expert knowledge of FDA safety regulations, ICH Guidelines, EU GVP and other applicable regulatory guidance documents; expertise in global safety regulations · Expertise in clinical safety assessments, safety signal detection and risk management, including interactions with regulatory authorities · Demonstrated ability to solve problems with innovative solutions along with strong organizational skills Possess strong and dynamic leadership skills, with excellent written, verbal and presentation skills · Effective team player, fosters collaboration within and across functional areas · Sound strategic evaluation, analysis, and decision-making skills · Ability to work in a dynamic, fast paced environment · Ability to balance competing interests of various stakeholders and strive for achieving mutually beneficial and compliant solutions Education & skills Medical Degree For further information on this role do not hesitate to email RECRUITERS All employment offers and CV’s are managed through our Human Resources Department and all candidates are presented through this avenue. Therefore, the Human Resources Department at Orchard Therapeutics requests that recruiters are not to contact Orchard Therapeutics employees directly to present candidates. Complying with this request will be a factor in determining future professional relationships with Orchard Therapeutics. Orchard Therapeutics will not accept unsolicited resumes from any source other than directly from candidates for either current or future positions. Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the recruiter does not create any implied obligation on the part of Orchard Therapeutics.