US-MA, Sr Scientific Manager Pharmaceutical Sciences Program Management 1602641-MZ
Sr Scientific Manager Pharmaceutical Sciences Program Management
Independently leads development of Pharmaceutical Sciences (PS) strategy and plans for multiple programs
Leads/contributes to functional strategy and initiatives.
Clearly communicates portfolio development to stakeholders.
Leads multiple global PS teams while ensuring the defined scope, budget, and timelines of the program(s) are met with high-quality deliverables.
Participates as functional expert in divisional initiatives.
Leads/represents PS on cross-divisional governance and development teams while providing strategy and accountability for PS deliverables.
Leads the preparation of the PS sections of global regulatory submissions (e.g. CTAs and commercial applications) and PS responses to regulatory agencies; represents PS at meetings with regulatory agencies as necessary.
Manages PS development activities being performed by a contract lab or manufacturing facility to ensure project deliverables are being met; reviews contracts and invoices as necessary.
Identifies and communicates project or program risks and provides risk response strategies in a timely manner to appropriate stakeholders and PS management
Identifies, evaluates, develops and communicates/negotiates criticality of new scientific standards and tools for potential implementation on programs.
Applies scientific knowledge and principles to solve project problems and significantly influence the direction of projects/programs.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS
Education / Experience
BS + 12 years; MS + 8 years; Pharma D + 7 years; PhD + 6 years
Thorough knowledge of pharmaceutical development, including an understanding of current laboratory techniques, instrumentation, problem solving techniques, process engineering and manufacturing development, and statistics used in experimental work.
Must have experience in global regulatory filings.
Must demonstrate knowledge of several allied fields, such as chemical engineering, analytical/organic/physical chemistry, process engineering, pharmaceutics, quality assurance and/or regulatory affairs. Fundamental understanding in DMPK, Pharmacology and Toxicology.
Extensive knowledge of current Good Manufacturing Practices (cGMP), ICH Guidelines, other pertinent national regulations, and compendial requirements
Must have knowledge in global regulatory submission requirements and processes.
Program Management Skills/Competencies
Proficient in the application of project management knowledge, skills, tools (e.g. Microsoft Project), and techniques for complex multidisciplinary programs.
Leadership develops and uses knowledge and interpersonal skills to influence and guide stakeholders towards the accomplishment of program and divisional goals and objectives; adapts well to varied team dynamics and manages team members in a respectful manner.
Risk Management ability to identify/mitigate technical, budgetary, and schedule risks to multiple programs and propose appropriate risk response strategies.
Communication ability to expresses one s self clearly and concisely to key stakeholders and functional management; documents issues and/or concerns concisely and comprehensively; adjusts style, language and/or terminology appropriate for the audience.
Resource Management ability to manage internal and external resources (people, information, technologies, time, and capital) based on program needs.
PMP certification is preferred.
Willingness to travel to various meetings or client sites, including overnight trips.
Some international travel may be required.
Requires approximately 10-30 % travel
Please visit our website at takedajobs.com