General Scope and Summary
SAGE Therapeutics is searching for a creative, resourceful, and integrative thinker for an important role that is responsible for overseeing the clinical development of our lead clinical trial programs in the field of neurology and CNS disorders. The Senior Director of Clinical Operations and Development will provide leadership and oversight for several global clinical development programs. Additionally, s/he will provide guidance and shared learning with and across teams, as well as to ensure clinical operational and development deliverables and timelines are met across the development program(s). This position will be accountable for the late stage infrastructure build within Clinical Operations, involving key stakeholders cross-functionally. This position will report to the Head, Clinical Development Operations.
Roles and Responsibilities
- Provide oversight for global clinical development programs, including Phase 2, Phase 3, Phase 4, and life-cycle management for lead programs.
- Accountable for the infrastructure build within Clinical Operations for our late stage programs, conduct of gap analyses, and driving the creation of necessary processes and procedures across multiple programs
- Lead and oversee program resourcing and budget forecasting
- Lead inspection readiness activities in Clinical Operations, swiftly applying lessons learned into practice
- Manage and lead a team of clinical operations staff with a focus on hiring, talent management and continuous development
- Strategist for the program development teams, creating clinical development plans and timelines, and partnering cross-functionally in a matrix model with PPM, Medical Affairs, HEOR, Medical Science, Pharmacovigilance, Clinical Supply, Regulatory, Finance, Data Science, etc.
- Provide guidance to the team on the evaluation, selection and management of Contract Research Organizations (CROs) and other external vendors to ensure successful clinical trial implementation and execution.
- Ability to build strong KOL and Principal Investigator relationships, with the ability to easily understand and explain complex scientific topics.
- Liaise with clinical site staff and Investigators as appropriate to ensure optimal Sponsor-site relationships.
- Oversight and consistency across clinical study protocols, informed consent forms (ICFs), clinical study reports (CSRs) and other clinical documents.
- Ensure compliance with GCP and adherence to activities outlined in various study plans.
- Participate in preparation of regulatory filings (e.g. IND, NDA, BTD, etc.) as needed.
- Ensure adherence to intended timelines and achievement of study goals while ensuring quality in accordance with FDA, EMEA, GCP, and ICH guidelines.
- Attend scientific conferences as needed.
- Serve as mentor for junior members of the Clinical Operations team
Experience, Education and Specialized Knowledge and Skills
Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient. Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations. Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.
- Master’s degree preferred in a scientific or healthcare discipline.
- Minimum of 18+ years in clinical and drug development in the pharmaceutical/biotech industry; 10+ years of managing people and building/leading team(s).
- Understanding of drug development and program management from pre-IND through NDA is essential. Must have been through a successful NDA/BLA previously.
- Experience is CNS/Neurology required
- Inspection readiness experience required
- NDA experience required
- Strong knowledge of clinical trial budget forecasting, building teams and resourcing, and contract management
- Extensive experience managing late-stage clinical programs, global programs, CROs, and budget/timelines required.
- Comprehensive knowledge of all pertinent regulations
- Management of CRO, multiple vendors, and complex protocols.
- Ability and experience operating in a matrix organization
- A detailed understanding of overall strategic direction, interrelationships and business needs.
- Proven experience in the oversight of the operational aspects of all stages of clinical studies.
- Problem-solving skills with ability to analyze situations and/or data while considering future impact and intangible variables
- Excellent oral, written, and medical communication skills required.
- Ability and willingness to travel up to 10% of the time, as needed.
- Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes.
- Strong team player that has a customer service approach and is solution oriented.
- Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
- Embrace our core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun.
- Excitement about the vision and mission of Sage.