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Your Path to Endless Opportunities

If you’re looking to push the envelope and join an innovative company where technology meets drug discovery and development and you’re enthusiastic, creative, with a passion for cutting-edge research, you should join our team! We are looking for highly motivated, passionate employees to help us drive technology solutions for discovering breakthrough treatments for our portfolio of oncology and neuroscience programs, as well as for our partners across major therapeutic areas.

Are You Ready to be Part of the Next Innovation?

Reports To

The Clinical Operations Professional will report to VP and Head, Clinical Operations and Project Management. 

Job Overview

Responsible for all operational aspects of assigned global clinical research activities and will liaise closely with other departments as well as with CRO/vendors. Responsible for appropriate execution and oversight of clinical operational development for several trials in various indications. Accountable for all activities associated, directly or indirectly with trial execution and clinical development, reporting and submission activities of the compound, as appropriate. Job title/role can be tailored to the right individual based on a combination of strengths and experience 

Responsibilities and Duties

  • Oversee and manage clinical operations activities to successfully execute the assigned clinical trial globally.
  • Ensure that all work is carried out in strict adherence with relevant protocols, SOPs, and in compliance with FDA and global health authority regulations and guidelines, as well as ICH/GCP
  • Oversees study operational teams and manages resources to ensure that study milestones and deliverables are achieved according to agreed quality standards and timelines and that quality of data is suitable for regulatory submission.
  • Actively contributes to Clinical Operations departmental activities and process improvement
  • Ensure timely feedback on study deliverables and reporting to senior leadership.
  • Develop, amend, and review clinical documents such as protocols, ICFs, Investigator Brochures, clinical reports, pharmacy manual and any other documents/plans supporting multiple clinical
  • Develop standards for internal documents such as: protocols, ICFs, safety management plans,
  • Training and oversight of all vendors associated with the assigned clinical trial.
  • Coordinate and drive clinical development programs with appropriate U.S. and International focus.
  • Provide routine direction, guidance and mentorship to clinical operations
  • Prepare or supervise preparation of a clinical monitoring plan for each project with realistic
  • Supervise conduct of clinical programs to ensure on time and on budget delivery of clinical
  • Manage staff to monitor clinical programs and studies for protocol compliance, user interface with product, and accuracy of
  • Prepare and manage the annual clinical operations
  • Ensures accurate documentation and control of all essential study documents, with the support of QA/Compliance.
  • Oversee the development of program and study timelines and
  • Oversee external vendors including research organizations, CROs, and central
  • Review and approve all research agreements and confidentiality requirements.
  • Any other responsibilities assigned by direct manager

Qualifications

  • Bachelor’s degree in Life Sciences, Pharmacy or Medicine required; advanced degree preferred, i.e. PhD, PharmD, MS, MPH.
  • At least 7+ years of clinical research experience in a pharmaceutical, biotech, or medical device industry is required; including 4+ years of clinical program management experience.
  • Experience managing a CRO partner in the conduct of clinical studies is required.
  • Knowledge and understanding of current regulations related to Phase I through IV clinical research.
  • Strong working knowledge of IRB regulations, GCP/ICH guidelines.
  • Knowledge of project management tools and practices.
  • Ability to understand and review detailed clinical reports.
  • Deep understanding of therapeutic area.
  • Experience managing a team of Clinical Operations staff with a demonstrated track record of effective clinical management.
  • Experience managing a budget and other concurrent multiple projects.
  • Solid basis in scientific approach and an ability to deal with in-depth technical information.
  • Fosters a high degree of scientific credibility with clinical agencies.
  • Demonstrated ability to manage conflict situations.
  • Ability to comfortably interact and clearly communicate with individuals at all levels of the organization including working closely with senior management.
  • Excellent verbal and written communication skills.
  • Ability to multi-task and prioritize.
  • Experience in Clinical Research Monitoring and Clinical Project Management; Comprehensive knowledge of Microsoft Word, Excel and PowerPoint.
Clinical Operations Professional: Apply Now

Primary Responsibilities:

  • Using strong project management skill, prepares regulatory Chemistry, Manufacturing and Control (CMC) content for global health authorities (IND, IMPD, NDA, MAA), within timelines and in accordance with regulations, and tracks documents, including associated tasks.
    • Leads the development and preparation of CMC-related documents and ensures they meet current regulatory standards, are high quality, consistent, complete, and approvable on the first review cycle. This includes, but may not be limited to, Biological License Application (BLAs), electronic Common Technical Documents (eCTDs), Investigational New Drug applications (INDs), briefing documents, Orphan Drug Applications, and Marketing Authorization Applications (MAAs).
    • Provides regulatory CMC summaries for Annual Reporting requirements.
    • May contribute to non-CMC related documents for IND and BLA submissions.
    • Leads IND maintenance to support clinical development activities.
    • Establishes product specific strategies to ensure successful development of CMC packages to support early development, registration and life cycle management.
    • Manages and participates in post-approval, global product activities. This includes, but may not be limited to, change control, product complaints, supplements and variations leading to labeling updates.
    • Develops timeline for responding to CMC-related inquiries from global regulatory agencies to ensure issues are addressed in a timely manner. Assists in the preparation and review of responses to global health authorities.
    • Participates in regulatory CMC-related health authority meetings and assists with the preparation of meeting packages and summaries/minutes.
    • Reviews and edits technical documents provided by the CMC function and extracts information necessary for regulatory submissions. This may also involve recommending changes to technical documents to ensure conformance with existing regulatory approvals.
    • Remains current on CMC regulatory intelligence including ICH, USP and other guidance.
  • Directs CMC Regulatory strategy development and implementation, providing expertise in CMC Regulatory for all products. Effectively interprets regulatory guidance and provides recommendations to key stakeholders.  Works cross-functionally, representing CMC Regulatory to external service providers and contract manufacturers, as appropriate.
  • Actively collaborates with development teams, Manufacturing, Technical Operations and Quality to develop and execute US regulatory strategies and contingencies for assigned projects during product development, validation and commercialization. Plans and manages CMC Regulatory project activities, including the development and maintenance of budgets and timelines. Ensures adherence to relevant regulatory guidance and regulations, as well as company Standard Operating Procedures (SOPs).  Participates in decision-making and risk-management process.
  • Creates, maintains and executes CMC Regulatory Project plans, timelines, and other tools required to facilitate planning and coordination of deliverables for each assigned Project. Facilitates the development of the integrated CMC Project plans relevant to the CMC Regulatory deliverables and ensures alignment across relevant functions and smooth transitions among pipeline stages.  Facilitates contingency and risk mitigation planning.
  • Interacts with Sr. Management / executive levels. Exercises judgment and exerts some influence on the overall objectives and long-range goals of the CMC Project.  May represent the department in relevant internal/external committees.

Education and Experience:

  • Requires Bachelor’s degree in any physical or Biological Science and at least 7 years of overall industry related experience. 5+ years of related CMC Regulatory experience
  • Advanced degree (M.S. or Ph.D.) a plus
  • PMP certified, MBA and/or experience managing projects a plus

Special knowledge or skills needed and/or licenses or certificates required:

  • Demonstrated, hands-on experience in pharmaceutical development.
  • Experience within a GMP environment with a firm understanding of industry regulations and best practices
  • Excellent working knowledge of the US and EMEA regulations for drugs.
  • Knowledge of global regulatory guidance
  • Ability to understand and interpret complex scientific issues across multiple projects as it relates to regulatory requirements and strategy.
  • Thorough knowledge of the drug development process, with a focus on IND and New Drug Application (NDA) processes.
  • Demonstrated experience in preparing IND and/or NDA submissions.
  • Excellent verbal and written communication and skills.
  • Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
  • Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
CMC Regulatory Director: Apply Now