Director, Clinical Research

Abbott•Alameda, CA

2d•Onsite

About The Position

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries. At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to: Career development with an international company where you can grow the career you dream of. Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan. An excellent retirement savings plan with high employer contribution Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune. A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists. We are seeking an experienced Director of Clinical Research to lead the strategic planning, execution, and oversight of clinical research programs. You will be responsible for applying clinical best practices, regulations, and quality standards for successful planning and execution of a clinical research program that includes internal studies, investigator-initiated studies and studies done with external partners including CROs to evaluate safety and efficacy. This position will be required to manage multiple projects simultaneously and meet targeted timelines while strategizing for issue resolution and study execution. You will need to partner and develop working relationships with new clinical sites, vendors, CROs and KOLs.

Requirements

Bachelor’s degree in a related scientific or medical field required
Minimum of 10 years of related clinical research experience
Demonstrated experience designing and conducting randomized controlled trials
Strong understanding of the scientific method and its application to well controlled clinical evaluations
Proven leadership experience managing and developing clinical research teams
Experience working with CROs, clinical sites, and external partners
Expert knowledge of ICH/GCP guidelines and clinical research regulations
Strong project management, budgeting, and organizational skills
Excellent written, verbal, and presentation skills
Ability to communicate effectively with cross-functional stakeholders and external regulatory agencies
Strong collaborative skills and experience working in matrixed organizations
Strategic thinker with the ability to manage multiple priorities in a fast-paced environment

Nice To Haves

Master’s degree, PhD, MD, or DO strongly preferred

Responsibilities

Direct the design, planning, development, and monitoring of all clinical research activities within the Division.
Plan and manage activities through project completion and coordinate clinical systems to ensure effective and efficient study execution.
Manage a clinical study team that may include Clinical Research Associates, Senior Clinical Research Associates, and Clinical Study Assistants, supporting hiring, development, training, and motivation to meet departmental needs.
Provide guidance, team building, and professional development for direct reports.
Establish and maintain systems to ensure adherence to ICH/GCP guidelines, including required training and successful outcomes from independent audits.
Evaluate and interpret clinical research data to ensure timely, accurate analysis and completion of final study records.
Manage the development of clinical trial protocols, final reports, clinical brochures, and the negotiation and execution of clinical site agreements.
Contribute to the development of strategic goals and the preparation of clinically and scientifically sound publications, manuscripts, abstracts, and presentations.
Work cross functionally with Medical Affairs, Quality Assurance, Regulatory Affairs, Marketing, and Legal organizations, as required.
Maintain up to date knowledge of relevant scientific literature.
Accountable for achieving performance and financial goals within your area of responsibility and demonstrate strong leadership and coaching skills to build effective relationships within the team and across the Division.
Prepare Clinical Project Charters outlining timelines, budgets, and personnel requirements, ensuring projects operate within approved scope and budget.
Determine and approve actions to address variances to meet the overall needs of the Clinical Research Organization and the Division.
Align functional goals with the Division’s long-term business needs and strategic objectives.
Maintain, promote, and model social, ethical, and organizational norms and ensure adherence to compliance standards and ethical principles.
Make timely, data driven decisions aligned with overall Division goals.
Communicate with cross functional partners (e.g., Product, Marketing, Regulatory, Quality, and Legal) and site leaders (e.g., Principal Investigators and Key Opinion Leaders [KOLs]) to execute strategic initiatives.