Gilead Sciences Inc

Director, Clinical Operations

Gilead Sciences Inc$210K — $272K *
Healthcare
8 - 10 years of experience
Job Overview by Ladders

Qualifications

  • 12+ years in clinical operations or life sciences with a BA/BS/RN, or 10+ years with a MA/MS/PhD/PharmD.
  • Prior experience in oncology clinical trials for company-sponsored studies.
  • Experience leading complex programs and cross-functional initiatives in clinical operations.
  • Proficiency in developing RFPs and managing CROs or other vendors.
  • Proven line management experience with a track record in finding and nurturing diverse top talent.
  • Demonstrated success in delivering high-quality outcomes on-time and within budget through effective CRO relationships.
  • Ability to build trust and credibility with senior leadership and cross-functional teams.

Responsibilities

  • Lead the Clinical Operations team and oversee Oncology programs, ensuring timely and quality deliverables.
  • Provide strategic operational input as the Clinical Operations representative on Global Development Teams and Clinical Science Teams.
  • Foster collaboration with global counterparts for budget-friendly program delivery and project communication.
  • Identify risks and opportunities proactively across programs to facilitate timely analytic judgment and clarity.
  • Challenge the status quo and take initiative on misalignment or emerging risks.
  • Apply comprehensive knowledge of study design and operational delivery to ensure endpoint quality.
  • Manage CRO performance through setting expectations and building productive partnerships.

Benefits

  • Medical, dental, vision, and life insurance plans provided by the company.
  • Participation in paid time off and a discretionary annual bonus.
  • Eligibility for discretionary stock-based long-term incentives.
  • Opportunities for national and international travel as needed.
  • Comprehensive employee benefits package with terms and conditions based on plan eligibility.
Full Job Description
Director, Clinical Operations – Oncology

We are seeking a strong, experienced Clinical Operations leader for a Director position within our Oncology Group. Clinical Operations is responsible for the worldwide execution of Phase I-IV clinical trials across all Gilead therapeutic areas and plays a key role in ensuring trials are conducted in accordance with applicable SOPs, company policies and regulatory guidelines. This work supports the timely delivery of high-quality clinical data for global registration and commercialization of Gilead’s products.

You will typically lead a large team of direct and indirect reports and be accountable for the operational strategy, financial oversight and successful execution of assigned Clinical Development Plans. You will represent Clinical Operations on internal and external strategy teams, such as Global Development Teams, and will oversee the execution of complex studies, multiple studies within a program, or multiple programs. You will also manage assigned program resources, lead Clinical Operations, cross-functional and/or country or regional organizational change initiatives, and may act as a business process owner or subject matter expert for complex Clinical Operations processes. You will demonstrate an innovative mindset by championing new ideas and incorporating best practices, external benchmarking and standardization across Clinical Operations.

RESPONSIBILITIES:
  • Provide Clinical Operations leadership and effective oversight of assigned Oncology personnel and programs, including tracking and managing deliverables and working cross-functionally with key stakeholders to optimize study-related processes and streamline timelines without compromising the quality of study deliverables.
  • Act as the Clinical Operations representative on Global Development Teams (GDTs)/Clinical Science Teams (CSTs), providing strategic operational input into Clinical Development Plans that significantly influences the direction and outcomes of product development strategies.
  • Establish and maintain strong collaboration and partnership with cross-functional colleagues globally to ensure timely, high-quality and within-budget delivery of programs. Keep stakeholders appropriately advised on project status and emerging issues.
  • Proactively identify emerging risks, issues and opportunities across programs before they become critical, applying robust analytical judgement to create clarity, frame options and translate insights into practical, outcome-oriented actions.
  • Demonstrate broad ownership beyond defined responsibilities by constructively challenging the status quo, taking initiative to address misalignment or emerging delivery risks, and acting with accountability for decisions, actions, and outcomes.
  • Apply an end-to-end understanding of study design, patient journey, operational delivery, vendor inputs, data collection and statistical considerations to identify and mitigate risks to endpoint quality and evaluability.
  • Provide effective CRO oversight by setting clear expectations, building productive partnerships that empower vendor expertise, addressing performance issues early and supporting on-time, on-budget, high-quality delivery.
  • Provide input into strategic and operational short- and long-range therapeutic area / functional area plans as appropriate, including supporting alignment and communications to other team members upon implementation.
  • Serve as a member of the Clinical Operations Oncology Senior Leaders Forum, providing key input into the leadership and management of the Clinical Operations Oncology team and driving department goals and initiatives to desired outcomes.
  • Lead and manage a team of direct and indirect reports. Hire, develop and retain diverse top talent on the team. Set clear goals for the team and individual direct reports. Coach direct reports on their performance, development and career interests. Play a lead role in developing other people leaders.
  • Lead development of resource plans for assigned programs to ensure optimal deployment and allocation of resources.
  • Ensure team’s work complies with established practices, policies and processes, and any regulatory or other requirements.
  • Initiate continuous improvement efforts, including identifying and applying best practices and driving standardization across teams and programs. 
  • Play a lead role in Clinical Operations and cross-functional organizational initiatives to drive ongoing efficiencies and operational excellence.
  • May also serve as the Clinical Operations representative on vendor governance committees, corporate partnerships, due diligence and/or acquisition teams, providing critical input into and review of partnership agreements and documentation.
  • May lead development of standard operating procedures (SOPs) and other procedures or documentation within Clinical Operations and/or cross-functionally.

REQUIREMENTS:

Minimum Education & Experience

  • BA / BS / RN with 12 or more years’ relevant clinical or related experience in life sciences. Or, MA / MS / PharmD / PhD with 10 or more years’ relevant clinical or related experience in life sciences.
  • Prior oncology clinical trials/operations experience in company-sponsored clinical trials
  • Multiple years’ experience leading high-complexity programs and/or cross-functional initiatives in clinical operations, including short- and long-range strategic planning, governance and oversight.
  • Experience developing RFPs and selection and management of CROs or other vendors.
  • Prior line management experience with proven effectiveness and success in hiring, managing and developing diverse top talent.  Preferably multiple years’ experience managing other people leaders (with indirect reports). 
  • Demonstrated ability to enable on-time, on-budget and high-quality portfolio delivery from CROs through effective expectation setting, oversight and partnership.
  • Demonstrated ability to build credibility and trust with senior leaders and cross-functional partners by adapting communication and influencing style to the audience and context, and by exercising sound judgement in escalation, conflict resolution and stakeholder engagement.


Knowledge & Other Requirements
  • Extensive experience in the delivery of registration-intent oncology clinical trial programs including understanding of oncology endpoints and approaches to ensure endpoint integrity.
  • Thorough understanding of pharmaceutical regulatory requirements and impact on development and execution of clinical trials, including knowledge of Food & Drug Administration (FDA) and European Medicines Agency (EMA), International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines and Good Clinical Practice (GCP) governing the conduct of clinical studies.
  • Proven ability and experience to effectively execute clinical trials within designated program budgets and timelines.  Strong financial acumen necessary for the development and management of clinical trial budgets.
  • Critical and creative thinker with demonstrated ability to operate effectively and independently in ambiguous and changing environments, balancing timely decision-making with appropriate evidence, reflection and stakeholder input.
  • Strong leadership presence and stakeholder management skills, with demonstrated ability to build credibility and trust with senior leaders and cross-functional partners, adapt communication and influencing style to the audience and context, lead without authority, resolve conflict constructively, and exercise sound judgement in escalation and stakeholder engagement.
  • Strong interpersonal skills and understanding of team dynamics.
  • Demonstrable abilities to effectively communicate project direction and status to varying organizational levels, including leadership teams, executives and steering committees.
  • Strong coaching capabilities to mentor and develop staff.
  • Demonstrated effectiveness in proactively managing change.
  • Strong track record in effectively conceiving and leading large-scale, complex change initiatives.
  • When needed, ability to travel nationally and internationally.

The salary range for this position is: $210,375.00 - $272,250.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

About Gilead Sciences Inc

Gilead Sciences is a research-based biopharmaceutical company that discovers, develops, and commercializes innovative medicines in areas of unmet need. With each new discovery and experimental drug candidate, they seek to improve the care of patients suffering from life-threatening diseases. Gilead's primary areas of focus include HIV/AIDS, liver disease, and serious cardiovascular and respiratory conditions.

Gilead Sciences Inc Careers

Join the vibrant team at Gilead Sciences Inc, a leader in the biopharmaceutical industry known for its innovative approach to healthcare. At Gilead, we are committed to advancing the care of patients around the globe through rigorous science and research.

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Start your career with Gilead through our internship programs, which offer hands-on experience in biopharmaceutical development and business operations. For seasoned professionals, our employment opportunities span across various disciplines, inviting you to bring your valuable skills to our team.

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Gilead Sciences Inc is not only a great place to work but also offers competitive benefits designed to support the health, well-being, and financial security of our employees and their families. From health insurance to retirement plans and wellness programs, we ensure our team members are taken care of.

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Learn more about Gilead Sciences Inc
Size
14,400 employees
Market Cap
$107.2 billion
Industry
Net Income
$123 million
Founded
1987
5 Year Trend
-2.1%
Revenue
$24.6 billion
NASDAQ

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