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Scientific Associate Director, Clinical Development

Cambridge, MA

Posted: 04/18/2019 Employment Type: Direct Hire Job Category: Clinical: Clinical Operations and Development Job Number: 2322

The Scientific Associate Director, Clinical Development will be responsible for the coordination of NDA/EMA Clinical development study related activities for drug development projects. The Associate Director will function as the technical expert on assigned studies and programs driving the consistency aspects of study design, data review and interpretation, program planning, data presentation, and data integration into summary documents and dossiers.   The Associate Director provides oversight of vendors and services to support literature searches, medical writing, PK/PD modeling, PK analyses, and other unique analytical or scientific services. The Associate Director will work closely with stakeholders providing scientific expertise and building effective relationships with other functional lines within the organization to ensure the optimal planning, execution and interpretation of clinical trials.

This individual will interface directly with other functions including Strategic Project Management,   Regulatory, Pharmacovigilance, Medical Affairs, Medical Writing, Regulatory Affairs, Clinical Operations, Research, and Pre-clinical Pharmacology and Toxicology.
Required Skills
  • Responsible for coordination and oversight of registration support activities of clinical program clinical trial data (safety and efficacy), including gathering, reviewing, interpreting, and providing preliminary assessments and recommendations for integration of results across study report and integrated summaries.
  • Is a direct contributor to development of INDs and NDAs.
  • Drives resolution of data issues from the clinical studies through effective delegation of tasks and follow up between data management, biometrics, Clinical Development and CRO team(s).
  • Assembles and lead review teams for review of Clinical CDT modular documents.
  • Coordinates clinical development staff reviews of individual protocols, study reports, study communications and slide presentations.
  • Coordinates with functional group leadership (Clinical Operations, Medical Affairs, Regulatory, Drug Safety Pharmacovigilance (DSPV), Early Stage Commercialization (ESC), Chemistry, Manufacturing & Control (CMC), pre-clinical research, project management and Finance) to assure progress and timely completion of program(s) and/or department goals.
  • Effectively communicate (oral and/or written) program-related information to Clinical Development management, Clinical Operations management, project management and integrated oversight teams.
  • Complies with FDA regulations and Good Clinical Practice (GCP) guidelines and SOP’ s for clinical studies.
  • Provides strategic input and negotiates resource requirements to use in establishing clinical milestones and timelines to Clinical Program Teams. Works with Project Management to identify key tasks, milestones and resourcing for individual programs.
  • Organizes teams of scientific staff to draft and/or review individual study information that will be included in regulatory documents including clinical sections of IND submissions, IND Annual Updates / DSUR, Investigator Brochures and IMPDs, briefing books, clinical sections for the NDA/CTD submissions, and responses to regulatory authority question
  • Assist the Senior Director and regulatory staff in the organization of scientific and regulatory reviews of key registration documents.
  • Support scientific aspects of study data capture, review and final presentation, including providing scientific review to eCRFs, edit checks, line listings, queries, and driving resolution of scientific issues as they arise.
  • Support activities necessary to conduct interim analyses or blinded data reviews that are delegated to independent committee or statisticians.
  • Assesses technology systems and streamlined processes for the integrated data review for identification of outliers, trends and pertinent safety signals that can assist Clinical Development Safety Reviews.
  • Lead or participate in sub-teams involved in continuous improvement and corporate initiative activities as appropriate.
  • Draft Clinical Research Standard Operating Procedures and Policies for Clinical Development related activities.
  • Provide clinical development and technical expertise in support of due diligence activities.
  • Assist in the identification and selection of external experts and clinical consultants.
  • Create relationships with key external experts (EE' s) to obtain medical and scientific input for clinical development.
Required Experience
  • Advanced degree: Masters, PhD, PharmD or MBA.
  • Minimum of 8 years’ experience working in biotech/pharmaceutical industry; preferably in clinical research group with a strong knowledge of drug development
  • Excellent oral and written communication skills and solid MS PowerPoint, MS Word, MS Excel, MS Project and analytical skills.
  • Ability to work collaboratively in a fast-paced, team-based matrix environment
  • High level of organizational, prioritization and project management skills
  • Flexible to accommodate changes in team and project needs

Lisa Madden
EVP, Clinical Staffing

Lisa is an inspiring leader and mentor, driven by an inherent desire to help others and make a difference. An advocate for growth and professional development, Lisa brings 18 years of recruiting and business development experience to The Steely Group, and as Executive Vice President of Clinical Staffing, she oversees the direction and strategy of the Steely recruiting team.

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