Associate Director, Clinical Outsourcing

4 weeks ago

Princeton NJ United States Sun Pharmaceutical Industries, Inc. Full time

The Associate Director, Clinical Outsourcing will lead the strategic identification and selection process with Clinical teams for clinical vendors and Clinical Research Organizations (CROs), lead negotiations, and scope specifications for clinical programs. In close collaboration with Legal and Finance, the position will be responsible for driving the development of key document templates and negotiation parameters, processes, and additional infrastructure to support drug development contracts.

 

Reporting to the Senior Director, Clinical Outsourcing, the Associate Director, Clinical Outsourcing will coordinate selection of all Clinical Development vendors and be able to identify and leverage efficiencies across programs. The position will partner closely with Clinical Development, Clinical Quality, Finance, Legal, Global Project Management and additional functional leaders to understand the project or study priorities to support timely delivery of negotiated contracts and budgets.

 

 

Duties and responsibilities

  • 20% Strategic Planning
    • Coordinates outsourcing activities across assigned clinical development programs.
    • Meets with project teams to gain an understanding of the scope of work and priorities of the various projects.
    • Works with study teams to determine overall outsourcing strategy.
    • Guides project teams through the outsourcing process and gives appropriate suggestions and advice on the best approach / best practices.
    • Implements defined outsourcing process to develop necessary documents; e.g., SOW template, transfer of obligations chart, payment schedule, kickoff meeting agendas, etc.
    • Formulates and harmonizes project scopes, plans, strategies, and budgets for assigned studies/programs.
    • Aids in the evaluation of potential outsourcing vendors (through effective bidding process and capabilities presentations).
  •    50% Vendor management: 15 – 25 Vendor per study
    • Participates in scheduling, organizing, and facilitating kickoff meetings with vendors.
    • Participates team meetings with vendors.
    • Supports the project teams to assure the quality and timeliness of deliverables through outsourcing.
    • Monitors and manages relationships with contracted vendors; facilitates the resolution of issues and conflicts.
    • Supports organizational governance activities with vendors.
    • Works with Project Teams to ensure outsourced clinical trial activities meet quality standards and expectations and adheres to applicable Corporate SOPs, WPs, policies, guidelines, and regulations.
    • Ensures smooth and effective communication between the vendors and the company.
    • Ensures Vendors/CROs are accountable and Identifies issues and develop solutions
    • Facilitates the closure of each study/contract with the vendor, including a mutual assessment of performance..
  •   30% Vendor selection and contract negotiation:
    • Guides and participates in the evaluation, selection, and negotiation of contracts for assigned studies/programs.
    • Works with Project Managers and Project Teams to develop RFPs.
    • Works with Project Managers and Project Teams for all operational, scheduling, project budget and cost-saving considerations for assigned studies/programs.
    • Liaises with project teams to develop the Statement of Work (SOW) for each contract; coordinates the SOW review and finalization process.
    • Negotiates new and amended work specifications, budgets, payment schedules, relationship management plans, and other documents that control the activities and performance of contract service providers..

 

 

Qualifications

  • BA/BS or higher required
  • 8 + years Pharma Industry experience with extensive knowledge of strategic sourcing and category management
  • Strong working knowledge of the Outsourcing for Clinical Trials
  • Demonstrated computer skills; functional knowledge of Microsoft packages (MS Word, Excel, Power Point, Outlook, MS Project, SharePoint), and knowledge of CTMS, eTMF and other project management programs
  • Exceptional negotiation skills excellent communication and the ability to influence.
  • Experience working with cross functional teams
  • Strong computer skills
  • Ability to analyze and review data

 

 

Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.

 

 The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.

 

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s).

 

We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.

 

 

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