Vice President, Clinical Operations

Location
San Francisco, CA, United States
Posted
Oct 10, 2020
Ref
3567-532-R
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Position Overview

Nektar has an exciting leadership opportunity for a Vice President, Clinical Operations to join their team.

This leadership position is accountable for resourcing, development, training, and management of a highly performing clinical operations team. Oversees all aspects of the Clinical Operations for identified program(s). This includes strategic and operational leadership relative to the direction, planning, execution, and interpretation of clinical programs and the data collection activities. Establishes and approves (with Project Physicians, CRO, Program Executive or Clinical Managers) scientific methods for design and implementation of clinical protocols, data collection systems and final reports. Overall responsibility for adherence to protocols and SOPs. Ensures good communication and teamwork with various inside/outside groups needed to facilitate clinical programs. May select, develop, and evaluate personnel to ensure the efficient operation of the function. This position reports into the Senior Vice President of Development Operations.

Essential Duties and Responsibilities:
  • Provides strategic operational guidance to ensure that trials are properly defined, planned, and executed across all clinical stage programs.
  • Establishes, implements, and proactively manages clinical trial processes, strategic outsourcing and performance indicators.
  • Ensures high standards for compliance with company SOPs, ICH-GCP guidelines, governing regulations and patient safety standards.
  • Lead and mentor the multiple functions and multiple levels within the clinical operations group to ensure successful internal trainings are conducted, and project, organization and individual goals are met.
  • Responsible for leading and managing clinical operations, allocating and directing internal resources and effectively utilize outsourcing to achieve project and business goals in a timely manner.
  • Responsible for leading and/or guiding creative and constructive interactions with clinical sites to ensure that all new clinical trials and programs have clearly defined plans/strategies and milestones.
  • Directs initiatives that accomplish continuous improvement and cost effectiveness to enhance operational efficiencies, product safety and GCP compliance and standardization of processes and procedures (e.g., GCP quality systems, SOPs/guidance, document management systems, etc.).
  • Coordinates and directs outsourcing activities across program(s) and oversees the clinical trials budgets.
  • Identifies program/resource gaps; devises and implements solutions.
  • Works with teams to ensure regular & high-quality enrollment and program updates are provided to Senior Management.
  • Provides strategic input to project risk analysis and solution development to a variety of complex problems.
  • Ensures that Clinical Operations department effectively interfaces with key functional groups.
  • Remains current with medical developments and publications on similar and competitor products. Applies this knowledge to current programs.
  • Mentors and develops Clinical Operations staff.
  • Works collaboratively across a broad range of people developing and maintaining good working relationships in order to facilitate a team-based approach to meeting the company's objectives.
Minimum Qualification Requirements:

A minimum of a Bachelor's degree in a scientific discipline is required. A Bachelor's/Master's degree in a medically related field such as nursing is highly preferred. Advanced scientific degree, such as a PhD in biological sciences or M.D. is highly preferred. Equivalent management and business experience (MBA) coupled with significant previous leadership experience may be accepted. A minimum of 15 years Pharmaceutical development experience moving product candidates from Phase I through pivotal, with at least 8 years managing CROs is required. Experience conducting and overseeing oncology trials is required. Experience with multinational or international clinical trials is required. Strong strategic/conceptual skills that can bridge the gap between the scientists and all of the business functions of the Company. Extended experience managing divisions or business units in a large company, preferably in the biotech industry is required. Solid resource management and planning skills. Must have experience in evaluating, negotiating and managing multiple successful relationships with partners, ability to set up milestones to track progress and working collaboratively with partners to achieve goals. Leads by example and models team behavior by soliciting opinions but is also willing to make key decisions and is effective in getting the team behind the decisions. Demonstrated skills in developing and fostering a team-based environment. Exceptional inter-personal, negotiation, influencing, communication and presentation skills (both oral and written) are required with the ability to interact with colleagues and partners at all levels of experience are expected. Successful track record of hiring, training, developing, mentoring and motivating team members to the highest level of performance. Flexibility to travel domestically and internationally, as required.

We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.