2018-10-20

Project Team Leader
Job Opportunity at Clinical Dynamix, Inc.

Posted on Oct 20

http://www.clinicaldynamix.com    561-732-4505

Location: San Francisco, CA
Job Type: Full Time
Job ID: W4167880

Acts as the "CEO" of assigned early development projects for the assigned division, which may involve managing direct reports. Acts as an expert product developer with proven entrepreneurial ability and mind-set; understanding the scientific, technical, clinical and commercial context for programs from clinical candidate selection (CCS) to readiness for phase III and enabling a seamless transition into later stages of development. Acts as a program champion and is objective and strategic about the project; striving to reach clarity in decision-making and tailoring the approach to address specific program needs. Provides high-quality leadership to global cross-functional early development teams. Creates a climate that increases the competitiveness of the product  by encouraging innovative approaches at an early stage and ensuring rigorous implementation of program plans. Monitors the external environment for changing trends and factors that influence current and future business models. Ensures that the overall vision/strategy for the project incorporates strategic options in alignment with disease area strategies, time, cost and risk and addresses technical, regulatory, business and operational needs. Develops and delivers clear communications of program strategy, progress and needs across the organization. Leads, motivates and organizes the program team to execute a cutting-edge project strategy in accordance with its goals and budget; assuring deliverables are met for clear decision-making and project transition to lifecycle. Sets challenging team goals and ensures that best practices are used to attain these goals with a sense of urgency, strong can-do attitude, and best possible performance. Creates a positive team environment that instills trust and ensures clear transparent communications and gets the team behind the overall goal/vision for the project. May select, develop, and evaluate employees to ensure the efficient operation of the function. MD may be required.
 
PTL's are responsible for:
  • Leading cross-functional Project Teams focused on the development of novel therapeutics including both large and small molecules.
  • Leading project teams from pre-IND to Phase III Go to deliver first- and best-in-class therapeutic molecules for pivotal clinical trials to enable successful global development and commercialization of (Research and Early Development) molecules
  • Provide direction and leadership to the project team including scientific oversight of activities, budget and planning.
  • Partner with stakeholders to develop project vision, strategy, product evaluation, product scope, project milestones, risk assessment and management strategies, as well as project investment requirements. Project Teams typically include representation from Research, Development, Commercial, Finance, Regulatory and Manufacturing.
  • Utilize his/her deep understanding of disease biology and global drug development to effectively lead Project Teams and to drive strategic decisions for the Early Stage Portfolio Committee. The PTL role will report into the Portfolio Management and Operations function 
Qualifications/ Requirements:
  • The successful candidate should have an advanced degree in life sciences or medicine (MD or PhD) and/or an MBA.
  • He/she will have at least 10 years of industry experience in drug development, including experience in early phase non-clinical and clinical drug development and regulatory knowledge.
  • Experience leading teams in a matrix environment and demonstrated skills in motivation of teams is required.
  • Candidate must possess a strong ability to cultivate excellent cross-functional collaborations.
  • Strong decision-making and analytical skills are required.
  • Excellent communication and influencing skills with a proven ability to work with executive management are critical to the success of the role.Acts as the "CEO" of assigned early development projects for the assigned division, which may involve managing direct reports. Acts as an expert product developer with proven entrepreneurial ability and mind-set; understanding the scientific, technical, clinical and commercial context for programs from clinical candidate selection (CCS) to readiness for phase III and enabling a seamless transition into later stages of development. Acts as a program champion and is objective and strategic about the project; striving to reach clarity in decision-making and tailoring the approach to address specific program needs. Provides high-quality leadership to global cross-functional early development teams. Creates a climate that increases the competitiveness of the product and Roche by encouraging innovative approaches at an early stage and ensuring rigorous implementation of program plans. Monitors the external environment for changing trends and factors that influence current and future business models. Ensures that the overall vision/strategy for the project incorporates strategic options in alignment with disease area strategies, time, cost and risk and addresses technical, regulatory, business and operational needs. Develops and delivers clear communications of program strategy, progress and needs across the organization. Leads, motivates and organizes the program team to execute a cutting-edge project strategy in accordance with its goals and budget; assuring deliverables are met for clear decision-making and project transition to lifecycle. Sets challenging team goals and ensures that best practices are used to attain these goals with a sense of urgency, strong can-do attitude, and best possible performance. Creates a positive team environment that instills trust and ensures clear transparent communications and gets the team behind the overall goal/vision for the project. May select, develop, and evaluate employees to ensure the efficient operation of the function. MD may be required.
     y area.
    PTL's are responsible for:
  • Leading cross-functional Project Teams focused on the development of novel therapeutics including both large and small molecules.
  • Leading project teams from pre-IND to Phase III Go to deliver first- and best-in-class therapeutic molecules for pivotal clinical trials to enable successful global development and commercialization of  (Research and Early Development) molecules
  • Provide direction and leadership to the project team including scientific oversight of activities, budget and planning.
  • Partner with stakeholders to develop project vision, strategy, product evaluation, product scope, project milestones, risk assessment and management strategies, as well as project investment requirements. Project Teams typically include representation from Research, Development, Commercial, Finance, Regulatory and Manufacturing.
  • Utilize his/her deep understanding of disease biology and global drug development to effectively lead Project Teams and to drive strategic decisions for the Early Stage Portfolio Committee.
  • The PTL role will report into the Portfolio Management and Operations function.
  •  
  • Qualifications/ Requirements:
  • The successful candidate should have an advanced degree in life sciences or medicine (MD or PhD) and/or an MBA.
  • He/she will have at least 10 years of industry experience in drug development, including experience in early phase non-clinical and clinical drug development and regulatory knowledge.
  • Experience leading teams in a matrix environment and demonstrated skills in motivation of teams is required.
  • Candidate must possess a strong ability to cultivate excellent cross-functional collaborations.
  • Strong decision-making and analytical skills are required.
  • Excellent communication and influencing skills with a proven ability to work with executive management are critical to the success of the role.

TWO positions available:    
One managing projects and portfolio related activities in the Oncology therapy area.
One managing projects and portfolio related activities in the OMNI (Ophthalmology, Metabolism, Neurosciences, Infectious Disease and Immunology) therapeutic areas.


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