Enveda is looking for a Clinical Operations Director, to join our team remotely!
The contribution you will make:
The Clinical Operations Director is responsible for clinical study planning, execution, timelines and budgets for the assigned clinical development studies/program(s). These responsibilities include, but are not limited to vendor identification and selection, preparation of study related materials, relationship management between study sites and vendors: in particular, oversight of CRO(s), study related activities, identification of project risks and contingency planning, as well as ensuring all activities are in compliance with GCP, ICH and other relevant guidances.
As a member of the Clinical team, you will report to the Head of Clinical Operations.
You get to collaborate on:Providing strategic input and execution of clinical trials from protocol design to the final clinical study report for the assigned studies. Leading and managing integrations of study team activities, leveraging internal resources, expertise and knowledge, along with optimizing CRO resources, expertise and knowledge. Managing CRO/vendor identification, request for proposal submission, CRO selection, and the day-to-day operational activities. Leverage resources, expertise, and knowledge within the CRO/vendor for smooth study execution. Overseeing study operations including study site selection and regulatory submissions, review of CRO monitor visit reports and site correspondence, drug supply and use, enrolment of subjects, regulatory document flow including informed consents (and translations), study timelines, all budgetary and financial information, performance metrics, data flow, etc. Participate in Case Report Form and/or EDC specification design and user acceptance testing, data management plan review, and data quality review and tracking. Effectively communicate and interact with Key Opinion Leaders. Lead the development of contingency/risk management plans for projects. Prepare budgets, timelines, and forecasts for clinical studies. Participate in development and review of Clinical Operation processes, systems and initiatives. Collaborating with oversight leads within assigned program(s) on clinical trial designs and strategy to ensure successful implementation of program(s)/trial(s) while anticipating and mitigating potential issuesManaging and overseeing financial aspects of assigned program(s) and trial(s)Managing and serving as the primary escalation point for internal and external team activities and serves as a key stakeholder for Clinical Operations within EnvedaRepresents program(s)/trial(s) to senior management, cross functional teams, and external partnersProvides input and support for regulatory activities including INDs and other regulatory submissions, inspection readiness activities and serve as a subject matter expert during regulatory inspectionsEnsures implementation and standardized use of Clinical Operations and Clinical Development Operations toolsUp to 30% domestic and/or international travelResponsible for line management, professional development, and mentorship of direct report(s) including providing feedback on employee performance and goal settingWho will thrive in this role?B.S/B.A. degree is preferred in a science/health care related field 8+ years' experience working within a pharmaceutical/biotech company, CRO, or similar organization.6+ years’ experience managing clinical trials, early phase experience is a must.4 years experience as a CRAExperience with global trial program execution preferredStrong knowledge of ICH/GCP/local regulationsProven ability to work in a fast-paced environment with demonstrated ability to prioritize and manage multiple competing tasks while maintaining timelines and ensuring overall quality and integrityProvide creative solutions when faced with unique problems/emerging situationsReputation as an open, available, and transparent communicatorStrong interpersonal skill set necessary to create and maintain internal and external collaborator relationshipsFacilitates productive dialogue that empowers others to share input/recommendations/perspective.Highly developed written and verbal communication skills, including ability to effectively articulate highly technical/complex concepts to audiences with differing levels of experienceDemonstrated ability to effectively navigate and manage within a matrixed organizationDemonstrated ability to inspire, motivate and mentor teamsIf you don't meet all of the requirements listed here, we still encourage you to apply. No job description is perfect, and we might find an even more suitable opportunity that matches your experience. What to expect in the interview process:HR Screen (30 minutes)Hiring Manager Interview (45 minutes)Work Sample Interview (45 minutes)Technical Interviews (60 minutes)Enveda Culture Interview (30 minutes)Some of the total rewards of working hereCulture: Enveda lives for peopleSalary: $200,000 - $220,000 EquityHealthcare: Medical, dental and vision insurance. Company pays 90% of premium for employee and dependents401k: Traditional or Roth 401k matching of 4% (100% of your contributions up to 4% of your annual compensation).PTO: Flexible paid time off (that we encourage and celebrate). Company-wide weeklong break to recharge. 10 observed holidays.Work-Life HarmonyAdoption Assistance: At Enveda we want to celebrate and support employees who want to adopt children. We're excited to offer adoption assistance to employees who have completed the adoption process, including placement.Come join us!
Our employees are the lifeblood of our work and our inspiration to press on. Together we've built a special place here—a drug discovery platform that's unique in the world with an incredible team collaborating in a creative, transformative culture. Our mission is to bring hope to patients everywhere. Our progress towards that goal would not be possible without talented people like you.
Employee Promise
Using our imagination and dedication, we are working to improve human health and give hope to patients everywhere. Our work together is empowering, trustable and collaborative, enabling you to do your best work.
Enveda's values
Curiosity: Learn and challenge.
Agency: Own and initiate.
Journey: Love the process.
Charity: Take care of each other.
Unity: We are one Enveda.
We value your uniqueness
One of life's gifts is to interact with a variety of people. Each of us has a unique story that shapes how we view the world, and solve problems. Learning from each other enhances our collective wisdom while achieving better outcomes at a faster clip. People from all kinds of backgrounds can succeed in all kinds of roles.
Our work environment appreciates the contributions of every person. Working together is how we produce results that illuminate our Purpose - To Deliver Hope To Every Patient. Unity is a company value because success depends on trusting, working relationships that respect the commonality and differences of people.
At Enveda we are building a place where every person can do the best work of their lifetime.
Enveda is an equal opportunity employer. We do not discriminate on the basis of characteristics protected by federal, state or local laws.
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