Director - Clinical Development - Work From Home
Sarah Cannon Development Innovations is a full-service contract research organization (CRO) that is uniquely focused in oncology. Sarah Cannon Innovations offers strong scientific leadership, access to patients through Sarah Cannon Research Institute's Site Management Organization (SMO) and relationships with other clinical sites, and experience in drug development and delivery of clinical trials from First-In-Man through registration level studies, making us the partner of choice for oncology.
Our differentiator is strong operational delivery in partnership with our Site Management Organization and physician leaders to deliver your program efficiently.
Sarah Cannon Development Innovations works with Sarah Cannon Research Institute strategic and network sites throughout the United States, along with investigators at sites outside of the Sarah Cannon Research Institute network. This reach allows Sarah Cannon Development Innovations to offer sponsors access to a diverse and varied patient population, spanning multiple tumor types and disease stages. These relationships further enhance the depth and breadth of Sarah Cannon Development Innovations' therapeutic expertise, enabling it to provide focused, strategic operational support. This support ensures that clinical trials are conducted in a timely manner and reported with high-quality, registration-standard data.
Sarah Cannon,* *the global cancer enterprise of Hospital Corporation of America (HCA), offers integrated cancer services with convenient access to cutting-edge therapies for those facing cancer in communities across the United States and United Kingdom.
Summary of Key Responsibilities:
The Director, Clinical Development is responsible for leading and supporting client relationship(s) and driving Sarah Cannon's input into the clinical development strategy for key compounds/studies within a client company's portfolio. This role is also responsible for oversight of the operational delivery of clinical studies at a program level (compound/portfolio of clinical studies). This role must have the capability to interact closely with clinical and non-clinical representatives as required at client companies.
Duties and Responsibilities
Duties and Responsibilities:
Duties include but are not limited to:
* Lead clinical development strategies for client programs (compound/portfolio of clinical studies) as appropriate
* Accountable for all program deliverables and client relationship
* Key point of contact, point of issue escalation and interface with client company(s) to lead relationship management, clinical strategy support, and if applicable presenting clinical development strategies to governing bodies and oversight committees
* Interface with the Sarah Cannon Physician Leadership, Scientific Leadership and Development Innovations Leadership Team to coordinate the strategic planning for client clinical programs and to support operational implementation and delivery of the associated clinical studies.
* Represent Sarah Cannon to the customer, ensuring satisfaction levels are maintained and program deliverables are communicated effectively
* Oversee interdisciplinary clinical research teams (matrix model)
* Oversight for development and implementation of program plans
* Ensure studies are conducted in compliance with GCP, relevant SOPs and regulatory requirements
* Responsible for program management components of inspection readiness for all aspects of the program conduct
* Responsible for the financial and operational health of all studies within the program or portfolio
* Proactively identify and manage issues
* Lead the development of contingency planning and risk mitigation strategies to ensure successful delivery of program goals program management reports for clients and management
* Implement resource strategies to achieve program goals
* Participate in bid defense meetings where presented as potential lead for program activities
* Lead operational input to proposal development and pricing including proposed program strategy
* Support operational excellence by identifying best practices, actively participating in Project Review Meetings, and by making recommendations to senior management
* Works on new initiatives and special projects as directed by President, Sarah Cannon Development Innovations / Sr. Director, Clinical Development
Minimum Required:Bachelor's Degree (4 Year Degree)
* At least 5-7 years of experience in a CRO/pharma/biotech organization; pharmaceutical experience is most preferred
* At least 5 years of oncology clinical research experience
* Experience working as a Director of Development/Head of Clinical Development; or experience working in clinical development strategy for a pharma company
* Experience working with clinical strategy support with various sponsor companies and senior leadership
* Excellent presentation skills to include oral and written communication skills
* 5-7 years or more of experience working in a pharmaceutical organization
* Bid Defense experience
* Clinical Project Management experience
* Prior experience working as a Director of Clinical Development at a pharma company
Do you find this opportunity compelling, if so we encourage you to apply? We promptly review all applications. If you are highly qualified you will hear from one of our recruiters. We are actively interviewing so apply today.
We offer you an excellent total compensation package, including competitive salary, excellent benefit package and growth opportunities. We believe in our team and your ability to do excellent work with us. Your benefits include 401k, PTO medical, dental, flex spending, life, disability, tuition reimbursement, employee discount program, employee stock purchase program and student loan repayment. We would love to talk to you about this fantastic opportunity.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Job: **Directors & Managers*
Title: Director - Clinical Development
Location: Tennessee-Nashville-Sarah Cannon Clinical Operations
Requisition ID: 25319-6379