Returning Candidate?

Sr. Manager/Associate Director, Clinical Outsourcing & Budgets

Sr. Manager/Associate Director, Clinical Outsourcing & Budgets

ID 
2017-1069
Category 
Clinical Operations
Job Location 
US-MD-Rockville
Type 
Regular Full-Time

More information about this job

Overview

MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies.  Our team of 300+ dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer as well as various autoimmune disorders and infectious diseases.  Our products and platforms have attracted multiple partnerships with leading pharmaceutical companies around the globe.

 

The Company considers its employees to be its most valuable asset and we are committed to providing opportunities for individuals to learn and grow as a means to further their professional development. MacroGenics' corporate culture promotes an atmosphere of innovation, open communication and teamwork where employees can see firsthand how they contribute to the success of the organization.

Summary of Position

The Sr. Manager/Assoc. Director of Clinical Outsourcing & Budgets will drive the Clinical Development budgeting process and closely manage the department budget including accruals and forecasts for ongoing studies in collaboration with Finance and the clinical study teams. He/she is also responsible and accountable for execution, management and oversight of all outsourcing and contracting activities within the product portfolio.  He/she will ensure adherence to compliance, financial, strategic sourcing, operational, and legal standards and goals, including accurate budget management for internal stakeholders and their projects, studies and initiatives. This position will have a direct impact on efficiencies through establishing and maintaining quality service provider relationships via defined selection, negotiation, contracting, and oversight practices. He/she is expected to create and foster a healthy network of contacts and relationships with assigned stakeholders and service provider organizations.

 

Responsibilities and Job Duties

  • Build partnerships with clinical development leadership, procurement, project management, legal, finance, and other departments as appropriate to ensure that outsourcing and contracting needs are met and handled in an optimal and efficient manner. 
  • Manage vendor-specific budgets and implement and manage appropriate reporting standards, controls and status reporting mechanisms for vendor contracts.
  • Manage clinical trial budget forecasts and accruals by partnering with clinical operations team.
  • Oversee creation and management of site budgets and development of strategic clinical site collaborations.
  • Develop cost estimates for study scenarios, forecast full study budgets and keep them up-to-date, working closely with each study manager.  Assist study managers with preparing accruals.
  • Collaborate closely with Finance to ensure prompt and accurate communication of budgets, accruals and forecasts and to address and/or resolve any budgetary or expense errors or other issues. In collaboration with Finance colleagues, troubleshoot budgetary, invoicing, change in scope and other related issues as needed. 
  • Develop budgets for new clinical trials and other Clinical Development activities.
  • Manage forecasts and accruals for ongoing clinical trials and other Clinical Development activities.
  • Champion clinical outsourcing initiatives, including development of strategic alliances.  Will manage clinical vendor identification and selection process. Establish clear objectives and expectations from vendor partners and develop clear mechanisms for tracking and measuring these objectives.
  • Drive the RFP, RFI processes and other vendor interactions to support initiation of clinical trials or other needs related to the growth of the product pipeline.  Lead negotiations on development of scope of work, budgets / rate cards with vendor partners.
  • Lead day to day outsourcing activities for assigned portfolio, including providing proactive, results-oriented, and business-based recommendations on the evaluation and selection of outsourcing services providers.
  • Facilitate issue escalation and resolution with vendor partners.
  • Meet with study managers, functional managers, and QA as needed to ensure vendors are meeting expectations and review progress against contract. Ensures that expectations within and between organizations with regard to establishing costs, budgeting and reporting, invoicing, turnaround times, contractual documentation and approach, payment schedules and other business practices are established and managed.  Facilitate issue escalation and resolution with vendor partners.
  • Create and maintain outsourcing SOPs, RFP and Scope of Work templates, Change Order and Change Notification Form trackers, Confidentiality Agreements (CDAs), Master Service Agreements (MSAs) and project-specific agreements.
  • Negotiate final scopes of work, pricing, and payment schedules with input from functional stakeholders in development, finance and legal. Approve clinical patient contract and budget negotiating parameters for CROs.  Negotiate change orders and ensure providers adhere to contract terms.  Review invoices of significance against vendor contracts to ensure accuracy against contracts.
  • Monitor market conditions and regulations, scientific, and technology trends and economics that affect the supplier pool and the clinical study process and effectively communicate trends to stakeholders and staff.
  • Develop, coach, and lead a team focused on supporting the clinical operations group with administrative tasks and to support the budget management.

Qualifications

Education

Bachelor’s degree in either life sciences or business or related degree

 

Experience - Senior Manager

  • Minimum of 7 years of experience with a focus on developing and overseeing clinical budgets, and contracts with clinical outsourcing vendors in the pharmaceutical/biotech industry
  • Previous experience negotiating, administering, extending, terminating and re-negotiating contracts
  • At least two years of experience supervising, leading and developing direct reports

Experience - Associate Director

  • Minimum of 9 years of experience with a focus on developing and overseeing clinical budgets, and contracts with clinical outsourcing vendors in the pharmaceutical/biotech industry
  • Several years of experience negotiating, administering, extending, terminating and re-negotiating contracts
  • At least two years of experience supervising, leading and developing direct reports

Knowledge, Skills and Abilities

  • Ability to influence without direct authority
  • Results driven with demonstrated successful outcomes
  • Ability and desire to work well with diverse employees and customers in a cooperative and friendly manner
  • Ability to handle multiple tasks and priorities in a fast-paced environment with awareness of deadlines
  • Excellent written and verbal communications skills
  • Proficiency in the use of Microsoft software (word processing, email, spreadsheet, database, and Internet)
  • Advanced skills using Excel and the ability to learn other database tools as needed
  • Ability to coordinate multiple group efforts within the company to achieve objectives
  • Excellent organizational and problem solving skills
  • Ability to identify processes needing improvement, and to recommend improvements
  • Relational understanding of the critical path of drug development process
  • Strong attention to detail and organization
  • Working knowledge of various contract types and complexity levels
  • Knowledge of clinical development financial principles including cash flow neutrality, payment schedules, costing systems, relational costs
  • Team player, collaborative, relationship oriented
  • Solid coaching skills that drive performance

Preferred Qualifications

Advanced degree in life science and/or MBA preferred

 

Supervisory Responsibilities

Three direct reports:  2 Clinical Trial Assistants and 1 Budget Manager

Statement

MacroGenics is proud to be an equal opportunity employer. Employment selection and related decisions are made without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, age, disability, protected veteran status, or any other characteristic protected by federal, state or local law. We are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please email info@macrogenics.com or call (301) 354-3566 and/or 711 for TTD/TTY service.

Equal Opportunity Employer/Veterans/Disabled

 

For more information about our commitment to equal employment opportunity, please click here.