General Scope and Summary
SAGE Therapeutics is searching for a creative, resourceful, integrative thinker for an important role that is responsible for overseeing clinical development of our lead late-stage clinical trial programs in the field of neurology and CNS disorders. The Director of Clinical Operations and Development will play a key role to manage, plan, and execute clinical development programs and studies, including creating and managing study timelines, budgets, and study management plans. Additionally, s/he will provide guidance and shared learning with and across teams throughout planning and implementation, as well as ensure clinical operational and development deliverables and timelines are met across the development program(s). This position will report to the Sr. Director, Clinical Operations and Development.
Roles and Responsibilities
- Robust understanding and experience leading late-stage clinical development programs, including Phase 3b, Phase 4, and life-cycle management.
- Responsible for the infrastructure build and creation of process for late-stage clinical development
- Lead the evaluation, selection and management of Contract Research Organizations (CROs) and other external vendors to ensure successful clinical trial implementation and execution.
- Create, manage, and execute clinical operations and development programs, including study management, budget and timeline creation.
- Manage and lead a team of clinical operations staff.
- Ability to build strong KOL and Principal Investigator relationships, with the ability to easily understand and explain complex scientific topics.
- Lead program development teams, and understand the intricacies among the different cross-functional groups, including medical affairs, HEOR, and other late-stage teams.
- Liaise with clinical site staff and Investigators as appropriate to ensure optimal Sponsor-site relationships.
- Author clinical study protocols, informed consent forms (ICFs), clinical study reports (CSRs) and other clinical documents as necessary.
- Develop and ensure execution of activities outlined in various study plans (data management, safety management, and study communication plans).
- Participate in preparation of regulatory filings (e.g. IND, pre-IND, orphan applications etc.) as needed.
- Partner with CMC/clinical supplies to provide drug supply assumptions and contribute to design and packaging of supplies for clinical trials.
- Manage all aspects of study progress from planning to close-out to assure adherence to intended timelines and achievement of study goals while ensuring quality in accordance with FDA, EMEA, GCP, and ICH guidelines.
- Lead, plan, and execute clinical Investigator meetings, study meetings, and vendor meetings as needed.
- Attend scientific conferences as needed.
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 10 years in clinical and drug development in the pharmaceutical/biotech industry (5+ years of managing people and leading a team).
- Understanding of drug development and program management from pre-IND through NDA is essential. Must have been through a successful NDA/BLA previously.
- Extensive experience managing late-stage clinical programs, CROs, budgets, and timelines required.
- Strong working knowledge of MS Project and developing Gantt charts.
- Experience monitoring clinical studies and conducting PSVs, SIVs, IMVs, and COVs required.
- Management of CROs, multiple vendors, and complex protocols.
- Protocol, ICF, and CSR writing experience required.
- A detailed understanding of overall strategic direction, interrelationships and business needs.
- Experience is CNS/Neurology preferred and experience with orphan indications will be favorably considered.
- Proven experience in the oversight of the operational aspects of all stages of clinical studies.
- Ability to organize and manage multiple priorities required.
- Excellent oral, written, and medical communication skills required.
- Ability and willingness to travel up to 25% 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.
- Possesses strong written and verbal communication skills.
- 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.