Timberlyne Therapeutics is a clinical-stage biopharmaceutical company focused on the development and commercialization of transformational therapies for high unmet medical needs. Timberlyne's lead program is CM313, an IgG1 monoclonal antibody with enhanced complement-dependent cytotoxicity that targets CD38. By targeting CD38, which is highly expressed on plasma cells, NK cells, and other immune cells, CM313 modulates multiple immune cell types leading to both rapid and durable responses across a range of autoimmune diseases and cancers.
Position Summary:
Timberlyne is seeking a Director/Senior Director to lead the Drug Safety function and provide expert support to internal stakeholders including Clinical Operations, Medical and Regulatory Affairs on matters of patient/subject safety. This person will be responsible for overall accountability for the expert output of the Drug Safety function. Successful execution will involve strong analytical and report writing skills to support the safety evaluation, benefit/ risk assessment, signal detection, aggregate safety report generation and responses to regulatory authority enquiries.
Essential Responsibilities:
Responsible for the identification, evaluation, management and escalation of safety risks.
Establish drug safety strategic direction and provide visible safety scientific leadership.
Oversee emerging safety profiles, including medical review of individual case safety reports, signal detection and evaluation, periodic safety reports, and risk management.
Represents DS on cross-functional safety teams and alliance teams.
Provide strategic safety input into global regulatory submission documents.
Prepare for and attend regulatory meetings, collaborating with external advisers and opinion leaders, effective collaboration with colleagues from partners.
Serve as a subject-matter expert in drug safety during regulatory discussions.
Ensure effective communication of product related aspects during audits and regulatory inspections.
Manage and supervise the drug safety CRO and oversee all data migration and cross- reporting activities.
Provides responses to enquiries from competent authorities (e.g., EMA and FDA) and partners.
Ensures expertise in risk management planning and reporting.
Provide drug safety expertise for due diligence activities as needed.
Oversees the safety set-up of all new studies including the preparation of study specific SAE processing documents and safety activities.
Ensures the company complies with changing requirements through updating procedures and practices as appropriate.
Verifies compliance with current legal obligations and guidelines and other industry standards relating to PV by keeping up to date on changes in legislation and practices relating to PV.
Skills and Experience:
MD with a minimum of 8 years of broad industry experience, including clinical development and pharmacovigilance.
Prior experience with NDA/BLA or equivalent regulatory submissions.
Strong knowledge of pharmacovigilance regulations and product development processes.
Experience managing safety issues.
Expertise in aggregate data analytics and related sciences (predictive modeling, epidemiology, health outcomes, biostatistics).
In-depth understanding of 21CFR, good pharmacovigilance practices (GVP) Modules and current drug safety/pharmacovigilance regulations.
Strong interpersonal skills required with a demonstrated ability to handle conflict situations, think strategically, generate solutions to problems, and build consensus across departments internally and suppliers externally.
Solid understanding of GCP/ICH guidelines.
Experience in planning, allocating and managing multiple projects.
Strong decision-making, negotiation, and influencing skills.
Excellent verbal and written communication in English.
How To Apply: Please send your resume to careers@timberlyne-tx.com
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity/expression, national origin, disability, medical condition, age, marital status, status as a protected veteran, or any other legally protected characteristic.