Director, Clinical Outsourcing

Location
Brisbane, California, United States
Posted
Oct 01, 2020
Ref
34021190
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Being a part of MyoKardia means you are a pioneer at heart, a go getter, a part of something meaningful. We push the boundaries, embrace uncertainty and challenge conventional thinking to make the biggest impact on people's lives - because we believe that a better solution is out there. We roll up our sleeves and get to work on making things happen - when the outcome of our work changes lives, action is a moral must. Each of us has a hand in shaping the future of our company, our industry and people's lives because the passion in each and every one of us is what makes the difference. If you are someone who dares to explore the unknown; who takes action in the face of uncertainty; who is passionate and driven about making a real difference in people's lives... then you belong at MyoKardia.

SUMMARY:

The Director of Clinical Outsourcing is accountable for managing clinical vendor budgets and contracts (and related ancillary contracts) for current and future clinical trials, including vendor identification, RFPs, vendor selection, budget and contract negotiations, budget management and service provider performance metrics. The primary focus will be to lead and establish a best practices category management and strategic sourcing program for the Clinical Development organization, actively supporting the build-out of our capabilities while developing a global network of preferred and strategic suppliers. Both strategic vision and tactical execution are key to success in this role. This position will report into Senior Director of Development Business Operations (Outsourcing and Procurement Services). The core duties and responsibilities of the Director of Clinical Outsourcing include, but are not limited to:

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Leads and provides expertise in clinical outsourcing and continues advancement of the organization's comprehensive clinical trials.
  • Leads or manages a functional team within Outsourcing and Procurement department.
  • Manages the day-to-day activities of multiple areas in complex clinical contracts and finance processes.
  • Develops strategic sourcing strategies for and provides oversight of activities for the development and execution of contracts with clinical vendors.
  • Independently manage the request for proposal (RFP/RFI) process (including service provider evaluation, bid summary & comparison analysis, and selection) for clinical service provider needs across all phases.
  • Partner with project leads/team members to manage service provider relationships and to oversee service provider performance (including financial relationship management) to ensure compliance against contracted services for outsourced work and managing or escalating issues as appropriate.
  • Establish and lead fit-for-purpose vendor governance committees in partnership with key stakeholders.
  • Benchmark and evaluate the market to identify potential suppliers. Including financial risks, spend history, trends, demands, and forecasts.
  • Leads in the development, improvement, and implementation of processes, templates, systems, and tools related to clinical outsourcing activities.
  • Directly supervises employees. Indirectly supervises employees through a dotted line structure or via other subordinate supervisors.
  • Leads contract life cycle management process related to clinical outsourcing.
  • Leads in cross-functional improvement processes and policies.
  • Manages review and negotiations of contract business terms in partnership with Legal, Finance, Clinical Operations, and other internal stakeholders as needed to ensure the timely execution of agreements to meet start up timelines.
  • Leads general and ad hoc projects as required.


EDUCATION/EXPERIENCE/SKILLS:

Education:

  • B.S. or B.A. degree or MBA, M.S. or M.A. preferred or equivalent combination of education and experience


Experience

  • 14+ years in clinical finance and budgeting, including advanced knowledge of clinical vendor budgets or clinical contracts management.
  • Experience in Biotech/Pharmaceutical industry. Understanding of Research and Development within the biopharmaceutical industry.
  • Experience in Life Science, Finance, and/or Business Strategy
  • Strong knowledge and understanding of FDA and ICH Guidelines, GCP's and medical terminology.
  • Solid understanding of drug development process including clinical trials in Phase 1 through 4 in global setting.
  • Excellent negotiation skills.


Knowledge/Skills/Abilities

  • Must be a self-starter who works with minimal supervision.
  • Ability to lead cross-functional team and facilitate communication with internal/external stakeholders. Ability to work with people across varying levels of responsibility within MyoKardia and with service providers and sites.
  • Excellent organizational and time management skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively.
  • Proven ability to negotiate costs, analyze and synthesize information to understand issues, identify options and support sound decision making.
  • Excellent computer skills including advanced knowledge in use of MS Excel, Word, PowerPoint MS Access knowledge preferred.
  • Demonstrates excellent written and verbal communication skills. Strong ability to develop and deliver presentations to senior management.
  • Works effectively with internal customers and vendors and depicts a team-oriented attitude.
  • Has an excellent analytical and problem-solving skill with a solution-oriented mindset.


Job Complexity

Works on very complex problems where analysis of situations or data requires an in-depth evaluation of various factors. May work on significant and unique issues where analysis of situations or data requires an evaluation of intangibles.

Exercises independent judgment in methods, techniques and evaluation of criteria for obtaining results.

Creates formal networks involving coordination among groups.