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Associate Director, Clinical Outsourcing

Foster City

 

MISSION

Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases affecting children and adults. Propelled by our passion for patients and their families, we’re focused on turning possibilities into realities. Using data and meaningful evidence, our goal is to transform scientific discoveries into therapies that are poised to positively impact the treatment of rare diseases. We are collaborative, creative, and experienced professionals and we’re looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously. Learn more about our work, our culture, and what it’s like to be a part of our team: www.mirumpharma.com.

 

 

POSTION SUMMARY

The Associate Director, Clinical Outsourcing is a core member of Mirum’s clinical operations leadership and drives the contracting process across a broad category of vendors for clinical studies, and is responsible for process improvements and governance with clinical study vendors for Mirum’s clinical programs.

JOB FUNCTIONS/RESPONSIBILITIES

  • Manages the contracting process across all clinical study vendors including vendor selection, budget and payment terms negotiation, and the contracting process including MSAs, study level contracts, PO generation, change orders, reconciliation and close out activities.
  • Partners with key functions of the Study Management Team (SMT) with direct responsibility to ensure all contracts and agreements support predictable delivery and quality, and that Mirum’s vendor base is aligned with Mirum’s strategic objectives, values, and policies.
  • Incorporates negotiated scope and budgets into executable contracts with suppliers, ensuring efficiency, accuracy and consistency in our agreements.
  • Leads vendor qualification and selection activities, in cooperation with the SMTs and clinical Quality Assurance.
  • In conjunction with Clinical Operations Leadership, develops and oversees governance structure with key vendors, co-leads governance meetings and ensures resolution of escalated issues.
  • In conjunction with Clinical Operations Leadership, develops and monitors key performance indicators of clinical study vendors ensuring corrective and preventive actions are taken to ensure delivery of objectives.
  • Proactively identifies and develops contingency plans for outsourcing risks and escalates to Clinical Operations leadership as necessary.
  • In conjunction with Clinical Operations Leadership, leads strategic vendor initiatives and operational vendor process improvements for Mirum’s clinical programs.
  • Leads the financial oversight on the program levels, including departmental level operating plans and ensuring adherence to planned budgets.
  • Oversees and provides guidance for monthly clinical study budget accruals in conjunction with FP&A.
  • Oversight of subcontracted vendors, in cooperation with the SMTs and Mirum’s CROs.
  • Oversight of vendor audit observations and CAPAs, including quality and timelines of the CAPAs, in cooperation with Mirum’s SMTs and cQA.
  • May participate in cQA audits, as Mirum’s Clinical Operations representative.
  • In cooperation with Mirum’s SMTs, oversees CROs resource planning, and timely resolution of resourcing issues, as applicable.
  • Acts as the escalation point of contact for strategic CRO partner(s) and Mirum’s SMTs.
  • Takes lead in overseeing and identifying innovative new vendors, to potentially mitigate program or study-level issues.
  • Oversees vendor aspects for inspection readiness activities, in cooperation with Mirum’s SMTs and cQA.
  • Oversees Mirum’s SOPs for clinical vendor management and oversight and updates as applicable.
  • Oversees planning, timelines and execution of clinical vendor transitions.

QUALIFICATIONS

Education/Experience:

  • Advanced Degree in Scientific/healthcare field preferred.
  • Significant experience (8+ years) of clinical research and organizational management within the pharmaceutical industry (Biotech/small pharma experience preferred).
  • Thorough experience of clinical study vendor oversight, including vendor selection, contract and budget negotiation, and financial management across the multiple facets clinical vendors may cover (CRO, ePRO, Central labs, Recruitment, Retention etc).
  • Global clinical trial research experience.
  • Experience leading cross functional teams.
  • Experience in rare disease is preferred.

Knowledge, Skills and Abilities:

  • Demonstrated ability and successful completion of a clinical program.
  • Demonstrated ability to oversee program-level vendors.
  • Demonstrated ability to lead and oversee vendor transitions.
  • Demonstrated ability to present complex information to management, vendors and external audiences.
  • Demonstrated ability to oversee program budgets including communication of overspend/underspend.
  • Ability to manage and communicate effectively with vendors including negotiating contracts, drafting and reviewing request for proposals, analyzing scope of work, responding to inquiries and complaints.
  • Strong attention to detail and the ability to establish priorities for the team.
  • Ability to work in a fast paced environment with demonstrated ability to juggle multiple competing tasks and demands, across time-zones.
  • Ability to work independently, take initiative, complete tasks to deadlines and support the clinical operations team in doing the same.
  • Demonstrated ability to lead, motivate and mentor teams.
  • Excellent written and oral communication skills.
  • Displays a high level of professionalism with internal and external stakeholders.
  • Proven ability to remove barriers to success.
  • Experience in line management or direct management of team members.
  • Strong knowledge of applicable computer and project management software packages.
  • In-depth knowledge of global regulatory/industry guidelines (e.g. ICH/GCP).
  • Passionate about evolution and innovation in clinical vendors and services.

#LI-Onsite

Mirum Pharmaceuticals is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and Local laws that prohibit employment discrimination on the basis of race, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability, veteran’s status or any other classification protected by applicable State/Federal/Local laws.

Mirum Pharmaceuticals provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in job application procedures.