Global Biotech company with US Headquarters outside Boston, MA is expanding. Looking for Dynamic Leader to work hybrid (out of Lexington, MA office) 2 or 3 days a week
The role of AD, Clinical Science is to guide and participate in all aspects of clinical development and study management. Reporting to the CMO and a high profile role. Responsible for Scientific input and writing, Clinical Evaluation planning, collaboration with key stakeholders and working with the head of clinical development. Leadership role responsibilities include scientific support to planned and ongoing clinical trials. May support more than one clinical protocol and portfolio. Works cross-functionally to ensure alignment across studies and to achieve the corporate objectives for programs.
Main Areas of Responsibilities
Authors, individually or in collaboration with internal and external partners, clinical materials, included but not limited to:
Clinical Investigation Plans and Synopses based on completed Study Designs
Patient Informed Consents
Clinical Study Reports
Clinical Evaluation Plans and Reports
Clinical Literature Review Reports
Additional Author additional clinical materials as needed
Annual Reports and when needed, ISE/ISS
Assist with reviewing topline results and preparing presentations for senior management as needed.
Contributes to, and reviews relevant documents and plans, including but not limited to:
Monitoring plan
Statistical analysis plan.
Reviews, tests, and approves specifications and edit checks for internal and external systems such as EDC and IVRS. As needed, reviews and trends clinical queries.
Monitors and reviews aggregate clinical data for trends/errors during the course of assigned studies. Identifies potential clinical data issues and recommends to management means of risk mitigation. Collaborates with Medical Affairs and Clinical Affairs in the review and management of safety related observations and issues.
Interacts with R&D and Clinical Operations to ensure adequate clinical supplies for the clinical trial. Oversees the shipment of Investigational Product supply, packaging, and labeling.
Supports planning and conduct of investigator meetings, Advisory Boards, Steering Committees, and DMCs
. Develop and deliver study specific training presentations as needed.
Provides support of publications
· Works with Project Management to establish, report, and update timelines and budgets.
· Support the development and management of study budgets for clinical programs. Track and manage site budgets efficiently and provide timely resolution to financial inquires.
· Evaluates potential vendors. Work with Contracts Management/Procurement to receive/review bid proposals, meet vendors, and contribute to vendor specifications development. Address any escalated issues related to contract negotiations as needed.
· Contributes to the development and review of SOPs, training guidances, and templates as needed.
May manage direct reports or supervise clinical study team member(s) as assigned. Recruits, develops, and supervises direct report(s). Conducts employee performance evaluations and provides direct report(s) with guidance on technical/project related issues and employee relations. Mentors and guides junior staff members to maintain team morale and high quality of deliverables..
May develop and deliver training related to study execution and COMPANY policy and procedures within department and cross-functionally.
Contributes to process improvement.
May perform additional research and contribute to submissions activities and/or responses to FDA inquiries as needed.
Education and Background Requirements
10 years of experience in Medical Technology Industry or Biotechnology Industry
PharmD, PhD, or MPH Preferred
Must have managed team in past and have strategy experience
Demonstrated experience supporting and managing the development, implementation, and completion of clinical trials and/or programs
Experience with all stages of clinical development
Site/vendor management and data review experience
Knowledge of medical device development and relevant regulations, including but not limited to, FDA GCP/ICH regulatory guidelines
Strong understanding of clinical trial design and basic knowledge of statistics
Proficiency with Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Outlook, and Adobe Acrobat
Must possess excellent skill/ability in the following:
Oral and Written Communication
Planning and Organizing
Decision Making, Judgment, and Problem Solving
People Relationships, Team Building, Motivating Employees, and Influencing Others
PEACE BEGINS WITH A SMILE – Mother Teresa
FOR IT IS IN GIVING THAT WE RECEIVE – Francis of Assisi
FAITH IS TAKING THE FIRST STEP EVEN WHEN YOU DON'T SEE THE WHOLE STAIRCASE – Martin Luther King, Jr.
LET ME WIN, BUT IF I CANNOT WIN, LET ME BE BRAVE IN THE ATTEMPT – Motto of the Special Olympics
NEVER TELL PEOPLE HOW TO DO THINGS. TELL THEM WHAT TO DO AND THEY WILL SURPRISE YOU WITH THEIR INGENUITY. – General George S Patton
WE CAN'T HELP EVERYONE, BUT EVERYONE CAN HELP SOMEONE – Ronald Reagan
THERE IS ONLY ONE WAY TO SUCCEED AT ANYTHING AND THAT IS TO GIVE EVERYTHING – Vince Lombardi
NO ONE IS USELESS IN THIS WORLD WHO LIGHTENS THE BURDEN OF IT TO ANYONE ELSE – Charles Dickens
LIFE IS 10% WHAT HAPPENS TO YOU AND 90% HOW YOU RESPOND TO IT – Lou Holtz
ONE LEARNS PEOPLE THROUGH THE HEART, NOT THE EYES OR THE INTELLECT – Mark Twain
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