Medical Director Cardiovascular Cellular Therapies
Deerfield, IL
Req ID 51183BR
Business Title
Medical Director - Cardiovascular Cellular Therapies
Business
Corp Innovation and Development
Sub-Business
Cellular Therapies
Country
US
State/Province
Illinois
Location of Position
Deerfield, IL
Shift_
1st
Job Description
Summary:
The Medical Director reports to the Vice President of New Therapeutic Development and is primarily responsible for oversight of all aspects of phase III clinical trials of cardiovascular cellular therapies. In addition, the Medical Director is also responsible for directing medical functions of the department, clinical development, new approvals, regulatory reports and peer-reviewed manuscripts based on Clinical Studies of the division.
Essential Duties and Responsibilities:
•Participates on strategic teams including the identification of new indications
•Strategically supports clinical trials throughout the evolution of clinical trial design, execution and completion of the study, providing medical and technical support
•Incumbent will provide medical technical perspective to the Business Development and Portfolio Management functions in the identification of potential partnering and internal opportunities
•Shares medical expertise with his/her counterparts in other functional areas such as Manufacturing, Quality Assurance, Regulatory Affairs, R&D, Legal and Marketing
•Provides input into clinical research strategy and drives the conduct of clinical trials for unlicensed products and optimizes new product development for successful launch into the marketplace
•Contributes to the development of the clinical strategies for new and existing Cellular Therapies products
•Assists in the development of general investigational plans, concept sheets and clinical protocols
•Works closely with Global Regulatory Affairs in the development of documents to support regulatory submissions
•Participates in conference calls and assists in the preparation of presentations to regulatory agencies, as requested
•Provides input to and coordinates development of study specific documents including Investigator Brochures (IB), statistical analysis plans, data management plans, CRFs and publications
•Provides relevant information to Clinical Scientific Affairs to support the compilation of clinical study reports, expert reports and publications
•Identifies key opinion leaders in the Therapeutic Area and cultivates their working relationship with Baxter as scientific consultants or clinical investigators
•Arranges and helps to conduct meetings of scientific and clinical advisors
•Assists in the preparation of yearly budgets for clinical studies performed within the TA and monitors performance to budget
•Negotiates and maintains timelines for studies with other Clinical R&D functions and monitors performance to timelines
•Review all reported adverse events in clinical trials of investigational products. Assess, query and recommend corrections to MedDRA coding of adverse events
•Approve MedDRA coding of adverse events
•Support and contribute to overall clinical research strategy, safety and conduct of clinical trials of products and/or new indication for a licensed product
•Provide strategic leadership to the department activities related to the evaluation and reporting of issues and adverse events related to products safety and efficacy, as well as strategies and activities associated with technical support for divisional products in the global clinical market
•Provide medical and scientific direction on clinical matters affecting preparation and submission of timely and sound information to the global regulatory agencies
•Work with product development and marketing functions to define the requirements and specifications for new products
•Maintain knowledge base as to developments and trends in medical science pertaining to his/her area of responsibility
•Contribute to the training, leadership and continuing education for all of Clinical R&D
•Participate in the development and writing of Clinical Trial Protocols. Provide input to investigator's brochure and interim/final CSR's
•Approve final clinical trial protocols, investigator's brochures and clinical study reports
•Serve as expert consultant to quality and medical vigilance functions in the investigation of adverse events and other product related issues
•Assist as requested in the preparation of periodic and other regulatory reports
•Supports commercial functions of Baxter by providing scientific background and advice
Job Requirements
•Requires a clinician whose previous education and experience supports their primary function of assuring the safety of clinical research subjects. Specifically experience in medical coding and classification and reporting of AEs and SAEs is required
•The position has a worldwide scope and all clinical development activities must comply with Good Clinical Practice specifications as practiced in different geographies
•Requires excellent interpersonal skills, presentation skills and technical writing ability.
•Must be experienced in managing multiple tasks, multicultural teams, and in the design and conduct of GCP compliant clinical trials
•Must interact successfully with a variety of individuals both within and outside Baxter Cellular Therapies, which include clinical investigators, contract research organizations (CROs), medical providers, patients, regulatory officials and individuals of various advocacy organizations with a particular interest in our products and clinical trial outcomes
•Must possess a comprehensive clinical knowledge of the area under inquiry as well as a keen understanding of study design principles (e.g. identification of key study end-points, power analysis, etc.) Education and Experience:
•M.D. degree required, with medical licensure in at least one state, and board certification in an appropriate specialty. An advanced research degree (Ph.D. or equivalent) is desirable.
•At least 10 years of total experience. Minimum 5 years related clinical or regulatory experience. Previous pharmaceutical/ biotechnology industry experience preferred
•The candidate must be willing to travel about 30-40% of the time
•Experience with team management and development
•Knowledge and understanding of national and international PV and regulatory guidelines
•Working relationships with and exposure to various Regulatory Authorities worldwide
•Knowledge of medical aspects of drug safety in Pre- and post-marketing safety practice
Preferred Qualifications :
•At least 3+ years of active medical or academic practice in the therapeutic area is desired
•At least 3+ years of relevant experience in the pharmaceutical/biopharmaceutical industry is desired
•A level of maturity for the interaction with opinion leaders in the medical community
•Ability to adapt and drive constant change is a critical attribute
•Computer literacy
•Excellent written and verbal communication skills, as evidenced by a record of publications and public speaking .
Doing Work that Matters
Baxter provides its employees with comprehensive compensation and benefits. To view additional opportunities at Baxter and to learn more about the company, please visit our Web site at company website. EOE M/F/D/V.
