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Associate Director, Clinical Outsourcing
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At Keros, our mission is to deliver significant clinical benefit to a wide range of patients with disorders that are linked to dysfunctional signaling of the transforming growth factor-beta (TGF-ß) family of proteins. With a focus on developing differentiated product candidates that are designed to alter TGF-β signaling, we aim to target the pathways critical for the growth, repair and maintenance of blood cells and a number of tissues, including bone, skeletal muscle, adipose and heart tissue. We believe our product candidates have the potential to unlock the full therapeutic benefits of modulating the TGF-β superfamily and provide disease-modifying benefit to patients.
Job Summary
This position will be a core member of the Clinical Operations team and lead the identification, evaluation and selection of clinical CROs/vendors. This role is responsible for creating an overall vendor strategy to establish and continually assess key performance indicators (KPIs) to help drive overall effectiveness and operational execution.
Primary Responsibilities
- Develop and execute a plan to bring on high quality diverse clinical vendors in a timely manner, ensuring a best-in-class approach to clinical trial outsourcing
- Drive the process to identify prospective vendors, solicit proposals, manage bid defense meetings etc.
- Obtain cross functional input to define KPIs and metrics and implementation of appropriate governance mechanisms to critically monitor ongoing vendor performance
- Manage negotiations and business partnerships to execute Agreements with optimal pricing and contractual terms to deliver the most value
- Serve as the primary relationship contact for clinical vendors and for escalation and risk mitigation of relevant operational issues
- Be a key contributor to help optimize efficiencies in the contracting and budgeting processes
- Ensure appropriate oversight documentation is developed, maintained and accessible
- Compliance with internal and external requirements/standards for vendor engagement and oversight
Core Competencies (Required Skills)
- 5+ years in the biotech/pharmaceutical industry in clinical outsourcing/vendor management with a track record of establishing high quality supplier relationships and sustained delivery of services
- Experience across international clinical trials across Phases 1-3
- Very strong communication, collaboration and change management skills
- Expertise in negotiating and monitoring KPIs across multiple vendors as part of a sponsor oversight strategy
- Excellent relationship management skills to help achieve and exceed functional and corporate objectives
- Demonstrated problem solving, conflict resolution and team building skills
- Understanding of regulatory standards and industry outsourcing trends
- Proven ability managing competing priorities, delivering actionable solutions that leverage best practices
Education Requirements
- Bachelor's degree required
Our Diversity, Equity & Inclusion Mission Statement: Keros is an inclusive company. We believe that diversity drives innovation. We continue to build an inclusive culture that encourages, supports, and celebrates the diverse voices of our employees. As such, Keros takes a holistic approach in mentoring, coaching, and developing all of our Keros team members.
Keros Therapeutics is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.
Recruitment & Staffing Agencies:
Keros Therapeutics does not accept unsolicited resumes from any source other than the candidate directly. Any unsolicited submission by an agency to Keros is prohibited. Any resume submitted by an agency without a signed contract or expressed consent by a member of the Keros Therapeutics Human Resources Department, will be considered property of Keros Therapeutics, and no fee shall be owed with respect thereto.
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