Worldwide Clinical Trials logo
Worldwide Clinical Trials

As a leading full-service global CRO, we work to create solutions that advance new treatments from discovery to reality.

Senior Director of Clinical Projects, Clinical Assessment Technologies

Medical DirectorMedical DirectorFull TimeRemoteSeniorTeam 1,001-5,000H1B SponsorCompany SiteLinkedIn

Location

North Carolina

Posted

2 days ago

Salary

$140.5K - $278.5K / year

Seniority

Senior

Postgraduate Degree10 yrs expEnglishGoogle Cloud Platform

Job Description

Senior Director of Clinical Projects, Clinical Assessment Technologies

Worldwide Clinical Trials

• Engage with senior management to establish strategic departmental initiatives and objectives • Accountable for clinical team key performance indicators (KPIs) and associated metrics • Drive identification of process improvement needs and coordinate initiatives to support these activities • Lead new quality management document (QMD) developments, including authoring and reviewing QMD and guidance documents • Create and lead CAT committees to further initiatives • Actively participate in the identification and development of new service arms • Actively participate in the improvement of existing service arms • Drive business development activities for CAT, including proposal input, participation in capabilities presentations, and bid defense activities • Participate in internal and external marketing activities • Serve as an external spokesperson for CAT • Provide oversight, training, and support for the clinical team • Actively engage in the protocol development process, including research, literature review, assessment review, and risk assessment • Identify clinical needs for upcoming and current projects, and track and review them with CAT Clinical Staff and Leadership • Resource CAT study projects as Resource Manager • Accountable for all contracted clinical activities in clinical trials • Provide clinical expertise and review of clinical plans and training content for CAT-awarded trials • Oversee development of assessment training content and plans, ensuring training curriculum and materials (including videos) meet protocol, copyright holder, author, and sponsor requirements • Serve as Subject Matter Expert (SME) for CAT clinical activities, including therapeutic area and assessment advisement and guidance • Provide clinical expertise on measurement administration and scoring conventions • Support scale acquisition activities, including scale versioning • Accountable or consulted, depending on study assignment, on source document creation to ensure materials align with study protocols • Lead development of data surveillance plans and oversee execution of data surveillance throughout trials • Accountable for CAT sponsor and team reports • Manage clinical staff directly • Lead vetting, hiring, and onboarding of new clinical staff • Oversee coordination and execution of onboarding and mentoring assignments • Oversee CAT study deliverables from launch through study closeout • Ensure CAT Clinical staff operate in a constant state of inspection readiness • Contribute significantly to strategic departmental, sponsor-related, and cross-functional initiatives • Collaborate with CAT staff, Project Management, and Contracts on study budget development, including Work Orders, Letters of Intent, Change Orders, and Change Notification Forms • Drive research activities, including data analysis, white papers, posters, and related contributions • Apply advanced knowledge of industry regulations, GCP, and ICH guidelines to ensure full operational and clinical compliance during clinical trial conduct • Perform other duties as assigned

Job Requirements

  • Master’s degree in life sciences or equivalent
  • At least 10 years of clinical trial experience with clinical assessments, including independently organizing and conducting projects and presenting at Investigators’ Meetings or similar forums as an expert clinician
  • Preferred minimum of 4 years of experience managing team members or providing direct clinical mentorship
  • Strong applied knowledge of pivotal efficacy measure administration conventions and the ability to train assessors
  • Knowledge of operational aspects of Phase I–IV clinical research trials and experience working with a Contract Research Organization or Rater Training Organization
  • Excellent collaboration skills and ability to work cross-functionally to drive projects and initiatives
  • Strong problem-solving and critical thinking skills
  • Demonstrated ability to apply knowledge and utilize resources to develop new ideas and improve existing processes
  • Excellent knowledge of SOPs, ICH/GCP, and regulatory guidelines
  • Competence in working with data and numerical analysis
  • Fluency in English, including reading, writing, and speaking, for daily business operations
  • Ability to travel domestically and internationally to attend key meetings, with flexibility to accommodate global time zones as needed

Benefits

  • Competitive benefits package depending on location
  • Transparent compensation

Related Categories

Related Job Pages

More Medical Director Jobs

Centene Corporation logo

Director, LTSS Clinical Care Management

Centene Corporation

Centene Corporation is a Fortune 500, mission-driven healthcare leader committed to transforming the health of the communities we service, one person at a time.

• Serves as the LTSS subject matter expert, leading RFP development and submissions while supporting the design, implementation, and growth of LTSS programs • Directs the long-term care of members with physical/medical health needs and/or behavioral/mental health needs to develop and assess high quality, cost-effective healthcare outcomes • Develops strategies and objectives within long-term care management to improve member and/or provider experience • Provides leadership to the development, implementation, monitoring, and ongoing improvement of the long-term care management process • Sets goals and objectives for long-term care management team and oversees care management data and reporting metrics to achieve quality and cost-effective healthcare results and working with senior leadership • Leads long-term care management policies and procedures within the care management team to ensure compliance with corporate, state, and National Committee for Quality Assurance (NCQA) standards • Oversees and monitors work assignments and caseloads of long-term care management staff based on state requirements, care management staff experience, and member needs • Monitors, reviews, and signs off on contract required reporting as required

United States
$127.3K - $236.1K / year
Full TimeRemoteTeam 10,001+Since 1980H1B Sponsor

• Support late-phase clinical development by translating scientific and clinical strategy into actionable execution across clinical trials • Serve as a key clinical development team member, providing hands-on oversight of protocol execution, medical data review, and clinical data quality to enable high-quality, decision-ready data • Work collaboratively within cross-functional teams to ensure clinical trials are executed in alignment with protocol intent, regulatory expectations, and Amgen quality standards • Serve as a clinical and scientific subject-matter expert for the assigned therapeutic area and disease indication, with a strong focus on protocol execution and data integrity • Contribute to medical monitoring activities and support ongoing assessment of subject-level clinical data to identify trends, risks, and emerging issues • Present information internally and externally, anticipating and actively managing problems across a broad spectrum of cross-functional teams • Provide guidance and assistance in the identification and management of collaborators, consultants, and/or Clinical Research Organizations (CROs) in completion of key projects • Work cross functionally to ensure clinical strategy is translated into the development of the study concept document, study protocol, and related documents • Ensure integrity of protocols and/or components of clinical plans and for the delivery of final protocol and its governance approval • Provide clinical input into & implementation of clinical trial(s), delivery, clinical data review, and interpretation of results • Review and analyze clinical trial data to ensure accuracy, completeness, and adherence to protocol and regulatory requirements • Conduct thorough data quality assessments in the context of a data monitoring plan to maintain high standards of data accuracy and integrity throughout the trial lifecycle.

United States
$211.2K - $285.7K / year
Recursion logo

Director, Clinical Science

Recursion

Decoding Biology to Radically Improve Lives

Full TimeRemoteTeam 201-500Since 2013H1B Sponsor

Role Description Your work will change lives. Including your own. The Impact You’ll Make: Recursion is at the forefront of reimagining drug discovery by integrating automated cell biology, high-dimensional and diverse datasets, and sophisticated analytics. We are seeking a Director-level Clinical Scientist who can oversee all clinical aspects of a clinical trial(s). This would include: - Planning and authoring clinical deliverables (protocols, amendments, medical monitoring plans, annual reports, study-specific updates, CSRs) - Routine medical monitoring - Site interactions/correspondence regarding patient eligibility and treatment inquiries - Presentations, both internal and external As an Associate Director within Clinical Science, you’ll play a critical role in ensuring study protocols are executed appropriately and that the study data is both appropriate and pristine. On a daily basis, you will interact cross-functionally with multiple disciplines supporting the Study Team (Clinical Operations, Medical Director, CMC, Data Management, CROs, CRAs, Investigative Sites, etc). You’ll be responsible for reviewing and cleaning/querying pertinent data points, identifying trends or inconsistencies with the data, and serving as the face of the study to Investigative Sites. You can expect to work on multiple early-phase projects at the same time in a fast-paced and exciting environment where the ability to multi-task and rapidly re-organize thoughts and priorities will be essential. In this role, you will: - Create: Serve as the authoring lead on multiple clinical documents. Recursion is moving away from the use of Medical Writers and relying more heavily on the Clinical Scientist and Medical Director to author IND and study-specific documents. - Collaborate: Work with highly dynamic teams where your role will range from leading and owning decisions or timelines to being a key contributor whose experience and insight are relied upon to advance the task at hand. - Drive & Deliver: You will be primarily responsible for the quality of your study data. This will include reviewing (Medical Monitoring); issuing, reviewing, and closing queries; reviewing TLFs, summarizing data throughout the trial, and presenting the data to management when requested. - Prioritize: Given the nature of Recursion, you will be required to support multiple early-phase (1-2) studies simultaneously. This will require time management and organizational skills. Qualifications - 5-7+ years as a Clinical Scientist in a pharmaceutical or biotech company - Prior experience in early phase 1-2 oncology studies is required - Experience with hematologic malignancies is preferred - Strong interpersonal and communication skills (both spoken and written) - Strong relationship-building skills to work effectively with others in various disciplines and levels - Proven ability to manage multiple, complex, and competing priorities to effective and efficient conclusion - Ability to operate strategically and tactically - Proven ability in problem-solving and issues management that is solution-focused Requirements - This is a fully remote opportunity with occasional travel requirements. - Travel may be necessary from time to time to support collaboration, team events, meetings, or other business needs. Benefits - Estimated annual base salary range for New York City, Boston, & San Francisco Bay Area(s): $234,190–$287,980 - Estimated annual base salary range for Salt Lake City & all other U.S. locations: $212,900–$261,800 - Eligible for an annual bonus, equity compensation, and a comprehensive benefits package. Company Description Recursion (NASDAQ: RXRX) is a clinical-stage TechBio company decoding biology to radically improve lives. Recursion is advancing a portfolio of differentiated investigational medicines across its wholly owned and partnered pipeline in oncology, rare disease, neuroscience, immunology, and other therapeutic areas with significant unmet need. Enabling its mission is the Recursion OS, an AI-native, end-to-end drug discovery and development platform integrating biology, chemistry, and clinical development into a unified intelligence system. Recursion’s platform infrastructure is anchored in Salt Lake City, Utah and Milton Park, Oxfordshire, where its automated biology and chemistry laboratories generate proprietary data at industrial scale. Recursion also maintains offices in New York, Montréal, and London.

United States
$212.9K - $288.0K / year
Full TimeRemoteTeam 201-500Since 2016H1B Sponsor

• Provide clinical development leadership to one or more programs. • Contribute to clinical development strategy in alignment with enterprise goals and management. • Serve as medical monitor for one or more studies. • Perform ongoing clinical trial data review and cleaning in collaboration with clinical science and pharmacovigilance. • Attend and contribute to study team meetings. • Present clinical trial findings to management. • Author clinical documents (protocol, investigator brochure). • Author clinical portions of regulatory documents (IND, CTA, NDA, MAA or equivalent). • Develop and manage relationships with key opinion leaders for clinical programs. • Organize, manage and lead Steering Committees and contribute to Strategic or Clinical Advisory Boards. • Contribute to writing of manuscripts, publications, or other documents intended for external audiences. • Contribute in an active and ongoing manner to the scientific, clinical, and commercial development of current and future product candidates. • Contribute to company culture and growth. • Foster communication, collaboration and coordination with other functions. • Contribute to maximizing synergistic collaboration between Ono and Deciphera. • Contribute to assessment of new internal or external targets by outlining clinical challenges and opportunities. • Support Medical Affairs activities as needed. • Participate in and/or coordinate cross-functional continuous improvement projects. • Act as an internal resource for functions requiring clinical input on select drug(s) including primary point of contact for clinical trial staff at study sites for clinical issues as well as regulatory, safety and other functions.

Massachusetts
$248K - $341K / year