Clinical Program Operational Lead (COL) US or Germany
Millipore Corporation

Job Info

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Work Location: Billerica, Massachusetts
Shift: No
Department: HC-RD-DOC Dev Ops Compound Lead
Recruiter: Jerome Henle

This information is for internals only. Please do not share outside of the organization.

Your role:

The Clinical Program Operational Lead (COL) is a global role within Global Development Operations (GDO). The COL is responsible for leading the development of the clinical operational strategy, comprising multiple trials and/or indications, and delivering the clinical development plan within agreed budget, timelines, and quality standards.

As a leader, the COL provides operational oversight, leadership, and strategic input for the planning and execution of clinical program(s). In close partnership with cross-functional teams, the COL leads the clinical program, from First-in-human (FiH) to the final launch of the asset. The COL represents GDO within the Global Program Teams (GPT) and serves as the key GDO operational point of contact for the program.

Key Responsibilities:

• Drive faster, cost-efficient, patient-centric trials following benchmarked industry standards and utilizing "state-of-the-art" clinical project management methodologies aligned to global drug development processes.
• Accountable for the successful preparation and presentation of operational content at key governance discussions, ensuring critical operational input is provided to drive comprehensive, strategic, and thoughtful discussions for assigned program(s).
• Develops the clinical operational strategy and delivers the clinical development plan within agreed budget, timelines, and quality standards.
• Accountable for successful project execution, including budget responsibility and clarification of project scope, working independently with guidance in critical situations
• Prepares and presents operational content at key governance discussions, ensuring critical support is provided to Clinical Trial Leads (CTLs) to drive comprehensive, strategic, and thoughtful discussions.
• Leads the successful execution of all operational components of global clinical programs, ensuring strong oversight, review, and quality delivery of program CAPAs to meet corporate compliance standards and timelines.
• Provides expert leadership and contribution to all operational aspects of the program budget, including oversight of individual trial budgets and forecasts to ensure delivery within R&D financial standards.
• Provides guidance and leadership support to Global CTLs and other members of the Global Development Operational team within the assigned program/project.
• Supports the development and implementation of department initiatives, including input on certain SOPs, processes, and workstreams.
• Manages projects/work streams with moderate complexity and risk, with substantial impact and reach within a group/sector sub-function or function. This includes leading a medium-sized project team with members from outside the direct working environment and a moderate to medium span of levels & roles.
• Contribute to creating a culture to attract, retain, and develop talent and actively engage with executives within the company and across the industry to share best practices.

Strategic Impact:

• Contributes to the overall strategic decisions for program and drives the clinical operations aspects of the strategy within the cross-functional program team and various clinical sub-teams.
• Develops innovative clinical operation strategies (including patient access and feasibility plans) across multiple indications, trials, and geographies
• Leverages strategic knowledge and serves as subject matter expert across TA portfolio for current drug development/clinical trial management processes, regulations, and therapeutic knowledge.
• Serves as an acknowledged authority, communicates difficult concepts, and negotiates with others to adopt a different viewpoint. Regularly presents to and consults line management, also at executive level.

Matrix Management of People:

• Leads Global Development Operations Team (and potentially multiple teams or a sizable team of professionals/managers/team leaders) and is accountable for the performance and results of the team within a matrix environment internally and externally
• Assess resource needs and makes recommendations for allocations across the program(s). Contributes to setting team member objectives, coaching, and developing employees, performance appraisal feedback

Candidate's Profile

Education:

• Candidate must have a minimum of a BA or BS degree; Advanced degree in Life Sciences (such as a graduate degree) (e.g., Biology, Chemistry, Pharmaceuticals) preferred or equivalent medical background
• Understanding of Oncology or neurodegenerative diseases or Immunology or any other TA as assigned depending on the assigned program preferred

Work Experience:

• At least 10 or more years of direct experience independently leading and managing global clinical trial program(s) in the pharmaceutical industry, as well as 3 or more years in a senior leadership position directing the operations of a large-scale global team and developing and mentoring junior colleagues.
• Substantial to extensive project management experience, combined with extensive professional experience and senior knowledge in their discipline and beyond, along with in-depth knowledge of the market and competitors.
• Strong leadership competencies and influencing skills with senior and cross-functional leaders.
• Effective oral and written communication skills to influence, inform, and guide a large-scale global operational team.
• Broad clinical operations experience and strong project management skills.
• Proven teambuilding skills and ability to foster partnerships across projects and multidisciplinary teams.
• Considerably deep and broad expertise with in-depth knowledge of competitors, industry challenges, and developments to achieve objectives and identify business opportunities.
• Comprehensive expertise in drug development, including profound knowledge of interfaces and interdependencies of clinical development with other functions such as nonclinical & pharmaceutical development, regulatory, commercial/marketing.
• Impacts through successful execution of projects, handles staff management issues, influences and convinces others, and contributes value-added perspectives or advisory services important to decision-making.

Location: : US (Boston area) or Germany (Darmstadt) on-site at least 3 days per week

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

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