Senior Director/Executive Director, Medical and Clinical Affairs Durata Therapeutics, Inc.
This Senior Director/Executive Director, Medical and Clinical Affairs will be responsible for managing projects within clinical development that lead to successful registration and approval of pipeline projects. In addition, this role will engage the external healthcare community to communicate the company?s product(s) and attributes. This position reports directly to our Chief Medical Officer.
OVERSIGHT AND EXECUTION RESPONSIBILITIES:
This position provides clinical input, including trial design, medical monitoring, and regulatory submission preparation, as well as managing the selection of clinical consultants and investigators. The responsibilities include the review and refinement of the clinical development protocols and plans, and works with colleagues in Clinical Operations and other Durata departments to ensure that the clinical goals for the company?s program are met.
Specific responsibilities include, but are not limited to:
Works closely with Clinical Operations to define a focused clinical strategy to support clinical studies
Manages external consultants to expertly advance the company?s development program
In conjunction with other relevant functional areas, develops the strategic development plan for compounds
Acts as the international clinical lead for the compounds to both internal and external stakeholders by providing high level input
Assists in the hiring, recruiting and retention of key high caliber staff in support of the development project
Provides medical leadership to the Commercial organization for development of training materials, medical and sales training, regulatory review, life cycle management and opinion leader relationships
Assists in the creation of clinical trial designs, synopses and protocols for the company?s clinical programs.
Works with Clinical Operations to ensure that all clinical trials have achievable goals and can be enrolled on the timelines proposed
Monitors project deliverables from inception to completion and achieves high quality results which meet clinical end-points in a timely manner
Collaborates with Safety Reporting disciplines to ensure timely and accurate adverse event reporting and follow-up
Collaborates with Regulatory Affairs to prepare for the company?s submissions, presentations, responses and guidance to the FDA or country specific regulatory authorities
Leads interactions with regulatory authorities, when requested
Collaborates with medical writers in the preparation of study reports
In collaboration with Clinical Operations, Regulatory Affairs and Quality Assurance, assists in the development of Clinical SOPs in accordance with ICH and GCP guidelines.
Carefully monitors clinical medicine and regulatory landscape in the target infectious disease indications.
Manages vendors (e.g. to include CRO selection and contract negotiations) and cultivating support from key opinion leaders.
Engages and establishes productive, interactive relationships with external constituents within the medical and scientific communities , such as health care providers, key thought leaders, institutions, and scientific associations/conferences to provide appropriate high-level scientific support
Leads and/or contributes to discussions with regulators and/or investigators, opinion leaders, internal and external clients, and project team support
Travels as needed (may be domestic or international).
Participates in initiatives and/or other activities as directed.
TRAINING AND EDUCATION:
MD degree required from an outstanding institution
Infectious Disease specialty board credentials highly preferred
Minimum of 5 years of clinical development experience in the pharmaceutical, biotechnology or CRO industries is required
Significant experience in the pharmaceutical and/or biotechnology industry with clinical development of small molecule compounds
Prior clinical trials experience in infectious disease, including studies with anti-viral and/or anti-bacterial agents and participation on clinical programs that have been filed for registration with the FDA is preferred
Experience working on clinical trials that led to the filing and FDA interactions for at least 1 NDA
Experience with the US FDA and EMEA, including pre-NDA, NDA and advisory committee interactions
Substantial experience networking within the infectious disease community preferred
A credible individual who can influence and work well with physicians, scientists, peers and managers
A results oriented, focused, proactive individual who can diagnose issues, learn from mistakes, solve problems and provide alternative solutions
An individual who demonstrates humility, good judgment, strong analytical skills, adjusting quickly to changes
Excellent organizational and project management skills and ability to think strategically
Outstanding presentation, written and oral skills required. A clear communicator who can influence effectively both internally and externally
Someone who can integrate into the environment, operate as part of an effective team, listens well and make important decisions
ABOUT DURATA THERAPEUTICS
Durata Therapeutics is an equal opportunity employer welcoming diversity in our workforce.
Durata Therapeutics is a biopharmaceutical company addressing the growing need for new therapeutics to treat infectious diseases. Durata's current late-stage clinical product, dalbavancin, is a next-generation lipoglycopeptide with unique features, including convenient, once-a-week dosing. To date, dalbavancin has been shown to be effective and well-tolerated in late-stage clinical trials of patients with skin infections, supported by a promising safety profile based on clinical data in over 1300 patients. The Company also has two antibiotic programs in earlier-stage, preclinical research.
Durata's senior leadership has substantial experience at leading healthcare companies, including in medical affairs, operations and manufacturing and with multiple U.S. and global product launches. Durata is supported by a premier team of venture capital organizations, including New Leaf Venture Partners, LLC, Domain Associates, LLC, Aisling Capital, Sofinnova Ventures Inc. and Canaan Partners.
||Branford, CT |