Director, Global Development Business Operations Clinical Development Execution
Dompé farmaceutici S.p.A., San Mateo, California, United States, 94409
Director, Global Development Business Operations Clinical Development Execution Excellence
Job Area: R&D/Medical
Job Category: Professionals
Job Site: Remote
Location: San Mateo, CA, US
Dompé is an Italian bio‑pharmaceutical company that focuses on innovation, where a long tradition in the field of personal wellness goes hand‑in‑hand with a commitment to research and development to meet unsatisfied therapeutic needs.
Established in 1940 in Milan, Dompé has an industrial and biotech research hub in L’Aquila, in addition to branches in Europe (Barcelona, Berlin, Paris and Tirana). The company has approximately 900 employees. The US headquarters of Dompé are based in Boston (R&D) and in the San Francisco Bay Area (Commercial Operations).
Job Summary The Director of Contracts and Business Operations, Clinical Development Execution Excellence (CDEE) is responsible for department level leadership for clinical/development contracts, key vendor governance, and business operations activities supporting Dompé clinical development programs.
The Director leads and mentors a team responsible for contracts execution and operational enablement, ensuring vendors perform in compliance with contractual, financial, and regulatory requirements and that clinical programs are delivered on time, on budget, and inspection ready.
This role ensures compliance with internal policies and external regulations, facilitates vendor and HCP contracting, and contributes to process optimization across R&D Development.
Job Description Leadership & Team Management
Lead and mentor a Contracts and Business Operations team, fostering professional development and operational excellence. Establish clear roles, performance expectations, and career development pathways.
Provide hands‑on guidance and escalation support for complex contracts, budget, and vendor issues. Drive consistency, best practices, and process maturity across contracting, vendor management, and business operations.
Contracts Lifecycle Management
Oversee end‑to‑end contracts lifecycle management, including MSAs, SOWs, Consulting Agreements, change orders, and closeout/reconciliation for Development functions and assigned clinical trials.
Partner with Legal, Procurement, Finance, Compliance and Functional leads to ensure contracts align with scope, timelines, budgets, and legal/compliance requirements. Ensure contract terms support effective vendor oversight, financial transparency, and risk mitigation.
Maintain trackers, templates, and SOPs to support scalability and audit readiness.
Vendor Governance & Relationship Management
Lead vendor governance frameworks, including oversight models, performance monitoring, and issue escalation. Facilitate vendor governance meetings and ensure accountability to contractual obligations and quality expectations.
Establish and foster strategic vendor partnerships to support Clinical Development success. Serve as a senior point of contact for assigned key vendor relationships (e.g., CROs, central labs, biometrics, imaging, eCOA providers).
Partner with Clinical Quality to support vendor qualification, audits, CAPAs, and inspection readiness.
Purchase Order & Financial Management
Oversee team purchase order (PO) creation, tracking, and reconciliation across Development engagements.
Ensure alignment between contracts, SOWs, POs, and invoices. Lead invoice review and approval processes to ensure accuracy and compliance.
Project Budgeting & Financial Oversight
Provide leadership for clinical projects and assigned Development functions’ budgeting, forecasting, and accruals procedures.
Partner with functional leads and Finance to ensure budgets reflect program/project plans and manage vendor scope. Drive spend versus forecast accuracy and proactively identify financial risks or variances.
Support portfolio‑level financial reporting and long‑range planning in conjunction with Head of CDEE and Development leadership.
Cross‑Functional Collaboration
Act as a strategic business partner to Development Leadership, Finance, Legal, Procurement, Quality, and Asset/Program/Project Leads.
Ensure vendor‑related operational and financial activities are aligned with study and program objectives.
Support regulatory inspections and internal audits related to vendor oversight and contracts.
Compliance & Process Excellence
Ensure all activities comply with ICH‑GCP, company SOPs, and applicable regulatory requirements.
Lead development and continuous improvement of SOPs, tools, and systems related to contracts, vendor management and business operations.
Drive standardization and efficiency as the organization grows.
Perform other duties, as assigned, to support the evolving needs of the CDEE function and R&D Development.
Education
Bachelor’s degree in Life Sciences, Business, Finance, or related field (required).
Advanced degree (MBA, MS) preferred.
Requirements
Minimum of 8-10 years of related experience within pharmaceutical R&D or broader healthcare industry.
Strong people management/team leadership, mentorship, and stakeholder management skills.
Extensive experience managing clinical contracts, budgets, and vendor financial oversight.
Strong understanding of global clinical trial execution and outsourcing models.
Expertise in clinical contracts and financial governance.
Proven ability to manage complex vendor relationships and resolve escalations.
Excellent negotiation, analytical, and organizational skills.
Deep understanding of GCP, regulatory expectations, and inspection readiness practices.
Sound judgment, strong work ethic, and commitment to ethical and compliance principles.
Excellent software and computer skills. Proficient with MS Office applications.
Travel 10-20% domestic and international as required.
Benefits of Joining Our Team
Comprehensive medical benefits: we value access to healthcare for our patients as well as our employees.
Generous vacation / holiday time off: we care about our employees and encourage a balanced lifestyle.
Competitive 401(K) matching.
Bay Area office with great views, located in vibrant downtown San Mateo and within walking distance to restaurants, coffee shops, and the Cal Train.
A super cool team who’s excited to transform lives through innovative therapies.
$216,200- 257,000 a year
At Dompe, we offer an attractive compensation package to our team members. Any offer would include a competitive base salary (estimate shared above), incentive bonus, and benefits package customary to the position. Actual individual pay is determined based on experience, qualifications, geographic location, and other job‑related factors permitted by law.
We believe that the unique contributions of all employees create our success. To ensure that our products and culture continue to incorporate everyone’s perspectives and experience, we never discriminate based on race, religion, national origin, gender identity or expression, sexual orientation, age, or marital, veteran, or disability status. All your information will be kept confidential according to EEO guidelines.
Nearest Major Market: San Francisco
Nearest Secondary Market: Oakland
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Job Category: Professionals
Job Site: Remote
Location: San Mateo, CA, US
Dompé is an Italian bio‑pharmaceutical company that focuses on innovation, where a long tradition in the field of personal wellness goes hand‑in‑hand with a commitment to research and development to meet unsatisfied therapeutic needs.
Established in 1940 in Milan, Dompé has an industrial and biotech research hub in L’Aquila, in addition to branches in Europe (Barcelona, Berlin, Paris and Tirana). The company has approximately 900 employees. The US headquarters of Dompé are based in Boston (R&D) and in the San Francisco Bay Area (Commercial Operations).
Job Summary The Director of Contracts and Business Operations, Clinical Development Execution Excellence (CDEE) is responsible for department level leadership for clinical/development contracts, key vendor governance, and business operations activities supporting Dompé clinical development programs.
The Director leads and mentors a team responsible for contracts execution and operational enablement, ensuring vendors perform in compliance with contractual, financial, and regulatory requirements and that clinical programs are delivered on time, on budget, and inspection ready.
This role ensures compliance with internal policies and external regulations, facilitates vendor and HCP contracting, and contributes to process optimization across R&D Development.
Job Description Leadership & Team Management
Lead and mentor a Contracts and Business Operations team, fostering professional development and operational excellence. Establish clear roles, performance expectations, and career development pathways.
Provide hands‑on guidance and escalation support for complex contracts, budget, and vendor issues. Drive consistency, best practices, and process maturity across contracting, vendor management, and business operations.
Contracts Lifecycle Management
Oversee end‑to‑end contracts lifecycle management, including MSAs, SOWs, Consulting Agreements, change orders, and closeout/reconciliation for Development functions and assigned clinical trials.
Partner with Legal, Procurement, Finance, Compliance and Functional leads to ensure contracts align with scope, timelines, budgets, and legal/compliance requirements. Ensure contract terms support effective vendor oversight, financial transparency, and risk mitigation.
Maintain trackers, templates, and SOPs to support scalability and audit readiness.
Vendor Governance & Relationship Management
Lead vendor governance frameworks, including oversight models, performance monitoring, and issue escalation. Facilitate vendor governance meetings and ensure accountability to contractual obligations and quality expectations.
Establish and foster strategic vendor partnerships to support Clinical Development success. Serve as a senior point of contact for assigned key vendor relationships (e.g., CROs, central labs, biometrics, imaging, eCOA providers).
Partner with Clinical Quality to support vendor qualification, audits, CAPAs, and inspection readiness.
Purchase Order & Financial Management
Oversee team purchase order (PO) creation, tracking, and reconciliation across Development engagements.
Ensure alignment between contracts, SOWs, POs, and invoices. Lead invoice review and approval processes to ensure accuracy and compliance.
Project Budgeting & Financial Oversight
Provide leadership for clinical projects and assigned Development functions’ budgeting, forecasting, and accruals procedures.
Partner with functional leads and Finance to ensure budgets reflect program/project plans and manage vendor scope. Drive spend versus forecast accuracy and proactively identify financial risks or variances.
Support portfolio‑level financial reporting and long‑range planning in conjunction with Head of CDEE and Development leadership.
Cross‑Functional Collaboration
Act as a strategic business partner to Development Leadership, Finance, Legal, Procurement, Quality, and Asset/Program/Project Leads.
Ensure vendor‑related operational and financial activities are aligned with study and program objectives.
Support regulatory inspections and internal audits related to vendor oversight and contracts.
Compliance & Process Excellence
Ensure all activities comply with ICH‑GCP, company SOPs, and applicable regulatory requirements.
Lead development and continuous improvement of SOPs, tools, and systems related to contracts, vendor management and business operations.
Drive standardization and efficiency as the organization grows.
Perform other duties, as assigned, to support the evolving needs of the CDEE function and R&D Development.
Education
Bachelor’s degree in Life Sciences, Business, Finance, or related field (required).
Advanced degree (MBA, MS) preferred.
Requirements
Minimum of 8-10 years of related experience within pharmaceutical R&D or broader healthcare industry.
Strong people management/team leadership, mentorship, and stakeholder management skills.
Extensive experience managing clinical contracts, budgets, and vendor financial oversight.
Strong understanding of global clinical trial execution and outsourcing models.
Expertise in clinical contracts and financial governance.
Proven ability to manage complex vendor relationships and resolve escalations.
Excellent negotiation, analytical, and organizational skills.
Deep understanding of GCP, regulatory expectations, and inspection readiness practices.
Sound judgment, strong work ethic, and commitment to ethical and compliance principles.
Excellent software and computer skills. Proficient with MS Office applications.
Travel 10-20% domestic and international as required.
Benefits of Joining Our Team
Comprehensive medical benefits: we value access to healthcare for our patients as well as our employees.
Generous vacation / holiday time off: we care about our employees and encourage a balanced lifestyle.
Competitive 401(K) matching.
Bay Area office with great views, located in vibrant downtown San Mateo and within walking distance to restaurants, coffee shops, and the Cal Train.
A super cool team who’s excited to transform lives through innovative therapies.
$216,200- 257,000 a year
At Dompe, we offer an attractive compensation package to our team members. Any offer would include a competitive base salary (estimate shared above), incentive bonus, and benefits package customary to the position. Actual individual pay is determined based on experience, qualifications, geographic location, and other job‑related factors permitted by law.
We believe that the unique contributions of all employees create our success. To ensure that our products and culture continue to incorporate everyone’s perspectives and experience, we never discriminate based on race, religion, national origin, gender identity or expression, sexual orientation, age, or marital, veteran, or disability status. All your information will be kept confidential according to EEO guidelines.
Nearest Major Market: San Francisco
Nearest Secondary Market: Oakland
#J-18808-Ljbffr