MindMed

Director

• Serve as Study Biostatistician for assigned clinical trials to provide statistical support from design, analysis to reporting
• Collaborate with cross-functional experts on clinical trial designs and make contributions to determination of objectives, endpoints and sample size
• Author statistical methods section in the protocol and review the protocol throughout
• Make certain the accuracy of randomization algorithm and contribute to eCRF design to ensure that study objectives, data analysis and data collection are aligned
• Be the primary owner of study statistical analysis plan (SAP) for the assigned clinical trials alongside the shells for table/figures/listing (TFL) that present the analytic results and reflect the analysis intent specified in the SAP
• Hold the primary responsibility of working with statistical vendors and internal Statistical Programming team to deliver study results with quality and speed
• Hold the primary responsibility of managing statistical vendors to deliver other data analyses as needed (e.g., DMC support, interim analysis)
• Provide statistical input to any form of data reporting or external dissemination, including clinical study report, regulatory communication and publication
• Conduct data analyses as needed by using own SAS programs in collaboration with internal Statistical Programming team

Associate Director, Biostatistics

Project Manager

• Manage activities within PPO and support interactions with other Departments, as delegated by department lead
• Lead the development of Project plan(s) to support functional areas such as Medial Affairs, QA, or to support Sr. Level PMs
• Help with system implementation to ensure awareness and alignment of project decisions, priorities, and key milestones
• Closely and proactively monitor the execution of the project plans and deliverables to ensure successful delivery of the program milestones, company milestones, and objectives

Project Manager – Program and Portfolio

• MindMed is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Our mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes.
• Founded in 2019, we are continuously expanding our presence and global footprint. We are constantly searching for high-impact individuals in various clinical, technical and business operations domains to strengthen our team of patient-centric, intelligent individuals.
• As Associate Director, Drug Substance Development you will be a technical leader and subject matter expert responsible for the synthetic route development, control strategy, scale-up, and supply from multiple CDMOs to meet program milestones. The ideal candidate will have a core expertise in small molecule synthesis and drug substance development experience from early development through commercialization.
• Responsibilities:
• Lead and direct drug substance synthetic route development, manufacturing control strategy, and scale-up at partner CDMOs
• Manage relationships with CDMOs to define and drive technical deliverables and ensure timely drug substance delivery to support pharmaceutical development and clinical trials
• Review and approve batch records, protocols, reports, and batch release and stability data
• Analyze/interpret data to support technical decision making, trend analysis, and root cause investigations
• Identify, mitigate, and document drug substance development, scale-up, and supply risks
• Effectively manage change controls, deviations, and CAPAs to expected quality standards
• Contribute to authoring of drug substance regulatory file sections
• Requirements:
• PhD or MS degree in organic chemistry or related discipline with a minimum of 6 years or 10 years, respectively, of pharmaceutical industry experience with demonstrated increasing responsibilities
• Strong working knowledge of current Good Manufacturing Practices (cGMPs) and Quality Systems
• Strong working knowledge of relevant regulatory requirements, pharmacopeias, and ICH guidance
• Subject matter expert in small molecule drug substance synthesis, scale-up, control strategies, and risk management
• Proven track record for partnering internally and externally to deliver Drug Substance development milestones on-time and right first time
• Ability to effectively collaborate, communicate, and influence in a cross-functional team environment
• Ability to work in a remote/hybrid environment
• Ability to travel domestically and internationally as needed
• The starting base pay range for this position is $157,262.00 - $185,491.00. Compensation will be determined based on several factors including, but not limited to, skill set, years of experience, and the employee’s geographic location.
• Employees in this role may be entitled to additional compensation, including bonus and equity. Benefits information is listed on our Jobs Page. The Company provides competitive benefits to employees including:
• 100% paid health benefits including Medical, Dental and Vision for you and your dependents
• 401(k) program with company match and immediate vesting
• Flexible time off
• Generous parental leave and some fun fringe perks!