Associate Director, Clinical Operations
Are you looking for a role with impact, exposure and growth?
Reporting directly to, and partnering with, the Head of Clinical Operations, the Associate Director, Clinical Operations will lead and own the planning, implementation and management of early and late phase clinical research studies, including creating and managing study timelines, budgets and study management plans in a fully outsourced model.
This role provides oversight of Clinical Research Organizations (CROs) and other vendors and may author, review and approve various study related documents and plans. This role will also manage Investigator Sponsored Trials. This position will help review/develop Clinical Operations processes and procedures for a growing department.
If you are looking for a highly visible, high impact role that comes with mentorship from, and exposure to, the highest levels of the organization, it is a great time to join this growing team. You will have the opportunity to not only learn and execute clinical operations in a fast paced, collaborative environment, but to help shape and define it!
You are perfect for this role if you are engaged by and want to be responsible for:
- Lead the study team to design, develop, execute and deliver clinical studies in accordance with clinical development plans/strategy and timelines
- Lead the evaluation, selection, and oversight of CROs and other external vendors to ensure successful clinical trial implementation and execution
- Anticipate, recognize and resolve issues; as necessary, manage escalation of study related issues with management and other R&D functions
- Contribute to the writing and review of clinical documents such as protocols, informed consent forms, investigator brochures, monitoring plans, trial reports and DSURs
- Review and approve study-related plans generated by CROs and vendors, and ensure the documentation is in accordance with GCP regulatory requirements and consistent with the protocol for assigned studies
- Liaise with clinical site staff and Investigators as appropriate to ensure optimal Sponsor-site relationships
- Lead planning and conduct of investigator’s meetings
- Monitor progress of clinical study activities and report on the progress of assigned clinical trials including budget and timelines
- May perform periodic visits to sites and/or CROs to assess progress of studies/protocol compliance
- Participate in the preparation, review, and training of SOPs
We would be thrilled if you brought the following with you:
- Bachelor’s degree is required. Scientific/health care field preferred, but not required.
- Minimum of 6 years in clinical development in pharmaceutical/biotech industry, at least 3 years of expertise in clinical trial management
- Thorough knowledge of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies globally
- Experience in orphan indications and/or stem cell transplantation will be favorably considered
- Extensive experience managing complex protocols, CROs, budgets, and timelines
- Experience monitoring clinical studies and conducting SQVs, SIVs, IMVs, and COVs preferred
- Strong verbal and written communication skills including clinical authoring experience
- Ability to organize and manage multiple priorities in a fast-paced, entrepreneurial environment
- Proven track record of effective leadership with excellent organizational skills and ability to work independently
- Strong interpersonal skills to interact with investigators, vendors, and individuals at all levels of the organization
- Must be willing to travel both domestic and international
To be successful as a leader and contributor within Magenta, you must be:
- Driven. You will be focused on the achievement of Magenta’s mission and major corporate goals.
- Results-focused. Demonstrated record of exceeding stretch goals, and willing to bring creative problem-solving skills to challenges along the way.
- Entrepreneurial. You will enjoy learning and being involved in the content of our whole business, thriving on a very fast-paced and growing business.
- Intuitive. You will have a demonstrated ability to work in the “gray zone” and anticipate challenges before they arise.
- A proven cross-functional leader. You will have demonstrated the ability to “influence without authority,” build teams, and achieve objectives across complex projects and organizational structures.
- Process-oriented, yet flexible. You will appreciate and be able to create and drive process, and at the same time recognize when rules are meant to be bent.
- Transparent and Articulate. You will have the ability to communicate clearly and concisely with all stakeholders.
- Enterprise-focused and Business-savvy. You will always seek to put the goals of the company first, and help others understand the tradeoffs we need to make across the business. You’ll also be interested in new business development opportunities, being able to bring those to the attention of the right teams at Magenta and able to support those activities as requested.
- Independent. You will be able to self-organize and operate effectively without significant day-to-day oversight, while staying tightly connected to key leaders and teams across the company.
- A role model for the company’s cultural pillars; Courage Commitment and Excellence