The Opportunity:

The Executive Director, Head of Quality, Europe is responsible for leading and overseeing all Quality functions across the European region, ensuring compliance with European regulatory requirements. This role provides strategic and operational leadership across GxP Quality (GMP, GDP, GCP as applicable). In addition, this role serves as the key Quality representative for Europe, partnering closely with Regulatory Affairs, Manufacturing, Supply Chain, Clinical Operations, and external partners to ensure a robust and inspection-ready quality system.

Key Responsibilities:

• Lead and develop the European Quality organization, ensuring alignment with global quality strategy and supporting the transition from clinical to commercial operations.

• Act as the primary Quality representative for Europe, providing leadership in regional and global governance forums and serving as the main interface with European regulatory authorities (e.g., EMA, national agencies).

• Ensure Quality oversight of MAH responsibilities, including lifecycle management, product complaints, recalls, and fulfillment of regulatory commitments in close collaboration with Regulatory Affairs.

• Establish, implement, and maintain an effective EU Quality Management System (QMS) in compliance with EU GMP, GDP, GCP (as applicable), and ICH guidelines.

• Participate in cross-functional review of Global SOPs, ensuring timely harmonization and effective implementation within the EMEA region.

• Oversee key quality system processes, including deviations, CAPAs, change control, risk management, product quality complaints, and document management.

• Monitor QMS performance through KPIs, risk indictors and management review process.

• Review quality agreements to ensure compliance with EU GMP, GDP and other regulatory requirements across the supply chain.

• Define and oversee the EU QP framework, ensuring compliant batch certification and appropriate governance of internal and/or contracted QPs.

• Ensure full compliance with EU GDP requirements, including oversight of distribution activities, wholesale authorizations, and Responsible Person (RP) functions within the EU supply network.

• Provide end-to-end Quality oversight of external partners (e.g., CMOs, 3PLs, distributors), including quality agreements, performance monitoring, and risk-based governance.

• Lead inspection readiness across Europe and manage regulatory inspections and internal/external audits, ensuring consistent positioning and effective interaction with authorities.

• Support regulatory submissions and lifecycle activities by ensuring quality oversight of relevant documentation and CMC components.

• Provide Quality leadership for new product introductions, technology transfers, and commercial launches in Europe, ensuring readiness of systems, processes, and partners.

• Collaborate cross-functionally with Regulatory Affairs, Technical Operations, Supply Chain, Clinical Operations, and Global Supplier Quality to ensure integrated and compliant execution across the product lifecycle.

• Drive a strong, proactive quality culture across all European operations, promoting continuous improvement and accountability.

Required Skills, Experience and Education:

• Degree in Life Sciences, Pharmacy, Chemistry, or related field (PhD, PharmD, or MSc preferred).

• 20+ GxP Quality within the pharmaceutical industry.

• Track record of building and scaling Quality organizations.

• Track record of working in a GMP/GDP regulated environment.

• Deep knowledge of European regulatory requirements (EMA, EU GMP/GDP, ICH guidelines).

Preferred Skills:

• Biotech experience.

• Significant leadership experience, including managing regional or global teams.

Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com. 

#LI-Hybrid #LI-LO1

The Opportunity:

RevMed is seeking an experienced privacy executive to support RevMed’s business.  The Executive Director, Global Privacy will lead the strategy, development, and execution of the company’s Privacy Program, ensuring all activities are conducted ethically and in accordance with applicable laws, regulations, and industry codes. This attorney will be instrumental in shaping and sustaining a culture of integrity as the company advances and commercializes its oncology pipeline.

The Executive Director, Global Privacy is a senior leader responsible for driving the organization’s global privacy strategy, governance, and compliance framework. This role ensures that all business activities involving personal data are conducted ethically and in compliance with applicable international laws, regulations, and industry standards.

Reporting to the Vice President, Compliance, this role serves as a key advisor to the General Counsel (GC) and other senior executives on global privacy, data protection, and responsible data use, while fostering a culture of privacy-by-design across all business functions worldwide.

The position can be based in the US or Switzerland.

Key responsibilities include:

Strategic Leadership & Governance

• Lead the development and execution of a comprehensive global privacy strategy aligned with business objectives and the broader compliance program.

• Serve as a senior advisor to the General Counsel (GC) and other senior executives on global privacy risks, regulatory developments, and data governance.

• Establish and maintain enterprise-wide global privacy governance frameworks, policies, and standards.

• Design the Global Privacy team structure and operating model leveraging both regional and global resources, support design and implementation of technology-enabled systems and processes for regional adaptation where appropriate and recruit a high-performing team.

• Provide regular updates to the General Counsel and other senior executives on global privacy program performance, risks, and mitigation strategies.

Global Privacy Program Management

• Design, implement, and continuously enhance a global privacy program aligned with international laws and best practices.

• Ensure alignment of the privacy program with the company’s overall compliance framework and enterprise risk management approach.

• Ensure compliance with global privacy and data protection regulations, including GDPR, UK GDPR, HIPAA, CCPA/CPRA, and other applicable international and local laws.

• Oversee Data Privacy Impact Assessments (DPIAs), cross-border data transfer mechanisms, and global risk assessments.

• Monitor and report on privacy metrics, trends, and program effectiveness across regions.

Clinical and Commercialization Data-Driven Activities

• Serve as the primary privacy lead for all clinical trial-related activities, including data collected from clinical sites, investigators, and patients.

• Partner with R&D and clinical teams to ensure compliant handling of sensitive clinical and health data.

• Collaborate with Commercialization teams to advise on processes, controls, and risks related to data-driven activities, including analytics, digital initiatives, and commercialization strategies.

Operational Integration

• Embed privacy-by-design and privacy-by-default principles into systems, products, and business processes globally.

• Partner cross-functionally with Compliance, Legal, IT Security, R&D, HR, and Commercial teams across regions.

• Support global initiatives involving sensitive data, including clinical, digital, and analytics-driven programs.

• Work closely with HR and Information Security (IS) to address employee and internal data privacy matters, including monitoring, investigations, and governance of workforce data.

Risk Management, Investigations & Incident Response

• Lead or oversee global privacy incident response, including breach assessment, notification, and remediation across jurisdictions.

• Lead and/or oversee privacy-related investigations, including internal reviews and regulatory-driven inquiries.

• Collaborate with Compliance and Information Security to ensure consistent global controls and preparedness.

• Identify, assess, and mitigate global privacy risks in alignment with enterprise risk management priorities.

Regulatory & External Engagement, Third-party & Contractual Oversight

• Serve as a key point of contact for global data protection authorities and regulators, in coordination with Compliance and Legal.

• Support global regulatory inquiries, audits, and inspections related to privacy.

• Oversee global privacy due diligence and risk management for third-party vendors and partners.

• Own and maintain privacy-related standards across the organization, including templates and playbooks.

• Review, negotiate, or oversee negotiation of privacy and data protection terms in contracts, including data processing agreements (DPAs), standard contractual clauses (SCCs), and related provisions.

• Ensure consistent and appropriate privacy language across all contractual forms and third-party engagements.

Training, Culture & Awareness

• Develop and deliver global privacy training and awareness programs aligned with compliance initiatives.

• Promote a culture of privacy, ethics, and accountability across all geographies.

• Partner with Compliance to integrate privacy into Code of Conduct, global policies, and enterprise training programs.

Required Skills, Experience and Education:

• Juris Doctor (JD); active bar membership a plus.

• Privacy certifications (e.g., CIPP/E, CIPP/US, CIPM, CIPT).

• 15+ years of experience in privacy, data protection, legal, compliance, or risk management

• Significant experience managing or leading global privacy programs in multi-jurisdictional environments.

• Experience in regulated industries (e.g., biotech, pharmaceutical, healthcare, or technology) preferred.

• Deep knowledge of global privacy regulations and frameworks (e.g., GDPR, UK GDPR, HIPAA, CCPA/CPRA, and other international laws).

• Experience with cross-border data transfers, data localization requirements, and global data governance.

• Strong understanding of privacy risk assessments, data lifecycle management, and compliance program integration.

• Familiarity with emerging areas such as AI/ML governance, digital health, and global data strategy.

• Ability to influence senior leadership and drive global, cross-functional initiatives.

• Strong strategic thinking with practical, business-oriented judgment.

• Excellent communication and stakeholder management skills across diverse geographies.

• Proven ability to lead teams and operate effectively in a matrixed, global organization.

• Strong organizational and project management capabilities.

Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com. 

#LI-Hybrid #LI-LO1

The Opportunity:

Reporting to the VP, GM, Midsized Markets, the Senior Director, Medical Affairs, Midsize Markets Europe, is the medical leader responsible for defining and executing the medical strategy for oncology products in our portfolio within Midsized markets. This role serves as the medical voice within the Midsized markets Leadership Team, ensuring scientific excellence, compliant medical engagement, and strong alignment between global strategy and local patient, physician, and healthcare system needs. This leader will ensure that Midsized markets medical considerations are embedded in the regional medical strategy and plans and will partner with the Midsized markets country managers and crossfunctional teams, as well as VP Head of Europe Medical Affairs and their leadership team. The incumbent will contribute to building the Midsized markets medical team and working closely with the Global, Regional, Country Medical Affairs teams across Med Affairs functions.

Responsibilities:

• Act as the Medical lead for Midsized Markets, accountable for medical strategy, execution, and impact across the RevMed portfolio.

• Serve as a core member of the Midsized Markets Leadership Team, contributing insights to medical and clinical development strategy, launch planning, and business decisions.

• Establish Midsized markets medical strategy across pre-launch, launch, and post-launch phases.

• Oversee all aspects of medical strategy and execution in Midsized markets.

• Cross-functionally align efforts seamlessly with access, regulatory, and commercial objectives while building and executing upon the medical plan.

• Collaborate effectively with regional and global teams by contributing to overall medical strategy, strongly partnering with local, regional and global clinical development and operations teams.

• Translate global medical and clinical strategies into relevant medical strategy.

• Represent the company as the senior medical expert within the local oncology and scientific community, acting as a spokesperson for Midsized markets.

• Gather, analyze and interpret clinical data, providing strategic insights to inform critical decisions.

• Build strong relationships with national key opinion leaders, oncology networks, academic institutions, and scientific societies.

• Lead scientific exchange, advisory boards, investigator and other external meetings, press conferences, and congress engagement at country level.

• Provide medical leadership on evidence generation activities including local studies, real-world evidence initiatives, and investigator-initiated research (where permitted).

• Ensure effective execution of publication plans and scientific communication activities.

• Lead medical launch readiness for oncology products, including training, scientific materials, and field medical engagement plans.

• Partner with Market Access and Commercial country and regional teams to support value communication and reimbursement-related interactions from a medical perspective, e.g. representing and defining evidence and value of innovation at oral HTA hearings.

• Support lifecycle management activities including new indications, label updates, and competitive positioning.

• Provide medical review and approval of non-promotional materials in accordance with local regulations and company policies.

• Help recruit country Medical teams, including Medical Directors and Medical Science Liaisons.

• Establish medical processes, governance, and ways of working as part of the Midsized markets build-out.

• Foster a culture of scientific rigor, compliance, and collaboration.

• Ensure all medical activities comply with local regulations, national and EFPIA codes, and internal company policies.

• Represent Midsized markets Medical Affairs in company governance and risk management forums.

Required Skills, Experience and Education:

• Advanced degree required (MD or PhD).

• Strong background and experience in oncology required.

• 10+ years’ experience in Medical Affairs with a track record of country leadership.

• Experience with scientific data generation, clinical trial interpretation, and communication of complex data to diverse audiences.

• Proven value and benefit assessment experience, with deep understanding of midsized markets access, local healthcare systems and regulatory landscape.

• Strong stakeholder management and ability to collaborate with internal and external partners.

• Proven experience supporting oncology product launches in a European market.

• Experience in biotech.

• Excellent communication skills, both in person and virtual.

• Proven leadership and people management capabilities; demonstrated success in small but fast growing, entrepreneurial environment.

• Demonstrated strong leadership presence.

• Has demonstrated adaptability and flexibility.

• Scientific and solution-orientated mindset and capability to move and execute in a rapidly changing, ambiguous environment.

• Strong understanding of local healthcare systems, customer dynamics, and reimbursement environment.

• Highly organized and motivated individual possessing excellent communication, presentation and interpersonal skills. Thrives in a fast-paced, dynamic small company environment and able to adjust priorities and workload based upon changing needs.

• Willingness to travel nationally and internationally.

Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com. 

#LI-Remote #LI-LO1

The Opportunity:

As part of our expanding European organization, we seek a strategic and hands-on Director, CMC Regulatory, Europe who will be responsible for developing and executing regional CMC regulatory strategies to support early development, marketing authorizations, and lifecycle management across Europe.

This role is responsible for ensuring successful interactions with the European Medicines Agency (EMA), national competent authorities (NCAs), and other regional regulatory bodies. It provides leadership across early- and late-stage CMC regulatory activities, including clinical trial applications, initial marketing authorization applications (MAA), post-approval variations, and lifecycle strategy.

The position requires deep expertise in EU regulatory frameworks, strong cross-functional collaboration, and the ability to proactively identify and manage regulatory risks while supporting business objectives.

Primary Responsibilities:

• Provide CMC regulatory support for clinical trial applications and regulatory interactions, ensuring alignment with EU requirements and timelines.

• Develop and lead execution of European CMC regulatory strategies to support initial marketing authorizations and lifecycle management of the company’s product portfolio.

• Oversee preparation, review, and submission of high-quality CMC dossiers for EU MAAs, variations, renewals, and line extensions.

• Serve as the primary CMC regulatory lead for Europe, managing interactions with EMA, NCAs, and other European regulatory bodies.

• Provide strategic input into global regulatory strategies, ensuring alignment while addressing EU-specific requirements and expectations.

• Assess regulatory impact of CMC changes and provide proactive, risk-based guidance to ensure compliance with EU regulations.

• Interpret and apply EU regulatory requirements (EMA, ICH, EU GMP, and national guidance) to support efficient regulatory pathways, ensure compliance, and proactively monitor and communicate evolving regulatory expectations across functions.

• Anticipate regulatory risks and develop mitigation strategies aligned with European approval timelines.

• Partner with global Regulatory Affairs, Quality, Technical Operations, and external partners to ensure consistent and compliant execution of submissions.

• Represent CMC regulatory on European or global cross-functional teams, ensuring alignment between global strategy and regional execution.

• Provide leadership, mentorship, and technical guidance to team members and contribute to building regional CMC regulatory expertise.

• Oversee external vendors and CROs to ensure timely, high-quality regulatory submissions and approvals.

Required Skills, Experience and Education:

• Bachelor’s degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related scientific discipline. An advanced degree (PhD, PharmD, MSc) is desirable.

• Minimum of 15 years of experience in pharmaceutical/biotech drug development, including at least 5 years in CMC regulatory affairs with European focus.

• Strong expertise in EU CMC regulatory requirements, including MAAs, variations, and lifecycle management.

• Direct hands-on experience in the preparation and submission of large, complex regulatory documentation to support health agency review/approval procedures, post approval activities

• Demonstrated experience supporting EMA submissions and interactions.

• Deep knowledge of EU GMP regulations and ICH guidelines, with ability to apply across the product lifecycle.

• Experience with small molecules (NCEs) and managing complex CMC technical documentation.

• Proven ability to lead regulatory strategy for European approvals within global development programs.

• Strong leadership and project management skills with ability to manage multiple complex programs.

• Excellent communication and stakeholder management skills, including experience working cross-functionally and with external partners.

• Ability to operate effectively in a fast-paced, matrixed, global environment.

Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com. 

#LI-Remote #LI-LO1

Ihre Aufgaben

• Rohrleitungsplanung in 2D und 3D über sämtliche Phasen von der Machbarkeit bis zur Übergabe für Prozess-, Forschungs- und Produktionsanlagen für unsere Kunden aus den Bereichen Biotech, Pharma und Chemie
• Unterstützung des Projektteams mit entsprechenden Unterlagen: Grundrisse, Schnitte, Isometrien, 3D Modelle und Visualisierungen
• Übernahme der Schnittstellenfunktion zwischen einzelnen Gewerken, Erstellung entsprechender Koordinationsmodelle und Koordination der Fachgewerkarbeiten
• Erstellen Massenauszügen sowie Stück- und Bestelllisten
• Weiterentwicklung der Modellierer-Standards (Projektfamilien, Templates, Strukturen) sowie Sicherstellung des kontinuierlichen Verbesserungsprozess innerhalb deiner Kompetenzfelder

Ihr Profil

• Abgeschlossene Ausbildung einer technischen Fachrichtung
• Weiterbildung (FH/HF) von Vorteil
• Anwenderkenntnisse in der Software Autodesk Revit, Aveva E3D, Autodesk Navisworks Manage, Revizto, AutoCAD oder die Bereitschaft diese zu erlernen
• 5+ Jahre Erfahrungen in Life Science Projekten sind von Vorteil
• 3-5 Jahre Erfahrung in der Koordination verschiedener Gewerke
• Sehr gutes Vorstellungsvermögen, flexible und kommunikative Persönlichkeit
• Selbständige und teamorientierte Arbeitsweise
• Sprachkenntnisse: Deutsch min. Level C2, Englisch min. Level B2

Über BakerHicks

Seit 1957 sind wir Vorreiter in den Bereichen Design, Engineering und Projektmanagement. Von der Beratung bis hin zum Bau und der Compliance unterstützen unsere multidisziplinären Design- und Ingenieurteams Unternehmen auf der ganzen Welt dabei, ihre Projekte auf die effizienteste, kostengünstigste und nachhaltigste Weise zu realisieren.

Benefits

• Überstunden voll kompensierbar
• Flexible Arbeitszeiten im Rahmen eines Gleitzeitmodells mit Blockzeiten
• Europäische Projekteinsätze möglich
• Rabattangebote im Stücki Center Basel
• Umfassende Spesenregelung zur Aufwandserstattung
• Mitarbeiter werben Mitarbeiter
• 2 verschiedene Pensionskassenlösungen (jährlich wechselbar)
• U-Abo für Pendler
• Flache Hierarchien
• Homeoffice
• Höchster Standard für Arbeitssicherheit
• 25 Urlaubstage
• Volle Lohnzahlung im Krankheitsfall bis zum 30. Tag
• Weltweite Reiseversicherung
• UVG-Zusatzversicherung
• Zuschuss für Velopendler
• Teilzeitarbeit möglich
• Möglichkeit zu unbezahltem Urlaub

Diversität & Inklusion

Bei BakerHicks ist es uns wichtig, dass wir ein Umfeld schaffen, in dem sich alle zugehörig fühlen. Als Unternehmen sind wir in der glücklichen Lage, mit einem vielfältigen Team von Menschen mit den unterschiedlichsten Hintergründen und Erfahrungen zusammenzuarbeiten. Alle von uns sollten respektvolles und positives Verhalten erwarten können, das uns anspornt. Um sicherzustellen, dass wir immer ein offenes Ohr haben und ständig dazulernen, haben wir ein Team zusammengestellt, das uns dabei hilft, unsere Strategien für Diversität und Inklusion zu steuern.

Über BakerHicks

Seit 1957 sind wir Vorreiter in den Bereichen Design, Engineering und Projektmanagement. Von der Beratung bis hin zum Bau und der Compliance unterstützen unsere multidisziplinären Design- und Ingenieurteams Unternehmen auf der ganzen Welt dabei, ihre Projekte auf die effizienteste, kostengünstigste und nachhaltigste Weise zu realisieren.

Benefits

• Überstunden voll kompensierbar
• Flexible Arbeitszeiten im Rahmen eines Gleitzeitmodells mit Blockzeiten
• Europäische Projekteinsätze möglich
• Rabattangebote im Stücki Center Basel
• Umfassende Spesenregelung zur Aufwandserstattung
• Mitarbeiter werben Mitarbeiter
• 2 verschiedene Pensionskassenlösungen (jährlich wechselbar)
• U-Abo für Pendler
• Flache Hierarchien
• Homeoffice
• Höchster Standard für Arbeitssicherheit
• 25 Urlaubstage
• Volle Lohnzahlung im Krankheitsfall bis zum 30. Tag
• Weltweite Reiseversicherung
• UVG-Zusatzversicherung
• Zuschuss für Velopendler
• Teilzeitarbeit möglich
• Möglichkeit zu unbezahltem Urlaub

Reisetätigkeit

Die Laufzeit unserer Projekte liegt meist zwischen 6 und 24 Monaten. Abhängig von Projekt und Projektphase ist der Einsatzort hauptsächlich der Projektstandort beim Kunden, wobei Mobiles Arbeiten von Zuhause in Absprache mit der Projektleitung teilweise möglich ist. Bei BakerHicks hat man so die Möglichkeit immer wieder bei unterschiedlichen Kunden mit unterschiedlichen Technologien zu arbeiten. Man lernt neue Städte kennen und ist dennoch am Wochenende immer zuhause.

Diversität & Inklusion

Bei BakerHicks ist es uns wichtig, dass wir ein Umfeld schaffen, in dem sich alle zugehörig fühlen. Als Unternehmen sind wir in der glücklichen Lage, mit einem vielfältigen Team von Menschen mit den unterschiedlichsten Hintergründen und Erfahrungen zusammenzuarbeiten. Alle von uns sollten respektvolles und positives Verhalten erwarten können, das uns anspornt. Um sicherzustellen, dass wir immer ein offenes Ohr haben und ständig dazulernen, haben wir ein Team zusammengestellt, das uns dabei hilft, unsere Strategien für Diversität und Inklusion zu steuern.

Ironwood Pharmaceuticals is a leading global gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients. We are pioneers in the development of LINZESS® (linaclotide), the U.S. branded prescription market leader for adults with irritable bowel syndrome with constipation or chronic idiopathic constipation. Ironwood is also advancing apraglutide, a next-generation, long-acting synthetic GLP-2 analog being developed for rare gastrointestinal diseases, including short bowel syndrome with intestinal failure. Building upon our history of GI innovation, we keep patients at the heart of our R&D and commercialization efforts to reduce the burden of GI diseases and address significant unmet needs. 

Founded in 1998, Ironwood Pharmaceuticals is headquartered in Boston, Massachusetts, and has operations in Basel, Switzerland.

Purpose/Summary: The Clinical Operations Lead owns program delivery & operational CRO/vendors oversight oof one or more development programs.

The Clinical Operations Lead has hands-on accountability and responsibilities in overseeing clinical trials execution within the program(s), especially the oversight of the trials/Program CRO, consultants and contractors to secure excellence in the delivery of their services to meet the trial milestones while adhering to quality, timeline, and budget. Leads by example with strong partnering and communication capabilities.

Key responsibilities:

• Takes a lead role in managing clinical program(s) and collaborating globally and across departments such as clinical development, regulatory, data management, biostatistics, drug supply, medical writing, and drug safety, etc.
• Supports creation and maintenance of the clinical development plan in collaboration with the Clinical Development Lead by providing input on operational aspects of the program and trials, including, but not limited to, budget, timelines, and vendors.
• Oversees CTT performance, including metrics, milestones and compliance with relevant regulatory standards, including ICH‑GCP, protocol requirements and company procedures.
• Collaborates with the Global Clinical Trial Managers (gCTM) and functions in the following activities, among others:
  • Support decision-making in the selection of study
  • oversight of CROs, vendors, consultants and contractors, including negotiation of Scope of work (SOW), ensuring delivery against contracted SOW, budgets, performance management and issue
  • Development and management of program timelines, budgets and
  • Oversight of trial subject retention
• Constantly scans for possible risks and implementation of mitigations; while identifying best practices and opportunities for trial efficiencies and opportunities for enhanced quality.
• Leads by example, onboarding, coaching, and mentoring other Development Operations team members, , fostering a team culture of ownership, engagement, and continuous improvement, ensuring recognition of team successes.
• Provides immediate supervision and line management to one or more employees, , including employee development, company goal setting, and performance management processes.
• Contributes to strategic vision and long-term plans of Development
• Supports in determining the best utilization and prioritization of resources, and the optimal organization of infrastructure and staff, leveraging experience working in varying resource models (i.e. Hiring, Functional Service Provider, CRO Full Package Outsourcing, etc.).
• Identifies and eliminates any impediments that obstruct or distract the team from delivering value; report and escalate issues, concerns, and roadblocks to management as needed.
• Regularly interacts with senior management on matters concerning functional areas and/or vendors.
• Contributes with the development and implementation of policies and standard operating procedures (SOPs) to be used in Development Operations
• Other duties as assigned

Prerequisite Education, Experience, & Skills:

• A highly motivated and results-oriented leader with a Bachelor’s degree and 14 years of pharmaceutical/Biotech clinical development and operations experience.
• Broad experience in global level clinical trial management, and knowledge of principles and practices of Program and Project Management. 
• Significant experience managing all aspects of activities in Phase I-IV trials, oversight of CROs and vendors at global level.
• Advantageous to have rare disease trial experience.
• Proven ability to effectively manage a large team comprised of permanent employees, consultants, contractors and oversight/partnering with CROs and teams within their varying levels.
• Intense drive and organizational expertise are necessary to manage the diverse group of functional activities involved in the international clinical trials program.
• Strong proficiency in GCP/ICH, U.S. drug development process and regulatory expectations related to global clinical trials execution .
• Excellent interpersonal, oral, and written communication skills.
• Ability to drive high-level decision-making, think strategically, and take initiative in the face of incomplete information
• Able to motivate teams to do their best work through active collaboration, healthy debate, and continued learning.