We are currently seeking a Head of Clinical Development who will provide cross-functional and medical leadership and oversight to support the planning, development, and execution of strategy for one or more medicines in development. This role will report to the Chief Medical Officer (CMO) and will lead the Clinical Development team and will lead decision-making and be a champion for our programs. To be successful in this role, you need a deep understanding of oncology drug development and must be able to manage physicians, clinical scientists and medical writing, and to lead cross-functional teams to analyze emerging data and competitive intelligence and to develop and execute strategies to achieve clinical proof-of concept and establish a path to registration and a plan for full development. The focus will be to deliver and leverage high-quality scientific and clinical data to inform strategy for the programs within the overall portfolio. You will lead the scientific and strategic development of program(s) within our overall portfolio from pre-clinical to registration.

Essential Functions and Responsibilities:

  • Manages the Clinical Team with a focus on developing processes and tools to ensure high quality delivery of development tasks with efficiency.
  • Directly or with team members, develops and executes robust clinical development strategy including protocol development and study execution.
  • Forms and chairs a Clinical Document Review Committee to ensure high quality protocols, amendments and other key clinical documents.
  • Chairs a Program Team, serving as the program’s primary point of contact for senior management.
  • Is a clinical and scientific leader and drives the science-based strategy for the program and the evaluation of benefit and risk.
  • Leads the effort to articulate and present an integrated cross-functional strategy for the medicine development and maintains accountability for the development plan.
  • Reviews and analyzes emerging data (both internal and external) to drive team recommendations that highlight opportunities, address potential risks, and provide appropriate mitigation.
  • Provides scenarios that optimize for opportunity, speed and/or funding and clear, prospective Go/No-go decision points.
  • Works with the team using objectivity and judgement to analyze, interpret and present data to internal and external stakeholders.
  • Establishes close ties with all team members and supporting teams to ensure appropriate empowerment and delegation and maintain aligned efforts. Coaches and mentors team members as appropriate.
  • Develops and executes robust clinical development strategy including protocol development and study execution.
  • Provides scientific and clinical leadership to program team and internal teams.
  • Along with project management, ensures that meetings are run efficiently and that agendas, background material, minutes, decision logs and risk assessments are complete and available in a timely manner.
  • In collaboration with Regulatory Affairs, engages with global regulatory health authorities as needed and ensures compliance with regulatory requirements.
  • Maintains overall responsibility for content of Investigators’ Brochure, IND, NDA, MAA and other submissions.
  • Presents at scientific meetings and advisory boards. Supports publication strategy and execution.
  • Maintains overall responsibility for specific product drug safety in association with the relevant functions.
  • Establishes and maintains relationships with key opinion leaders and other external partners to support clinical development strategy.
  • Engages with alliance partners, as necessary.
  • Travels Domestically and Internationally as required for team engagement, investigator relationships and scientific exchange.

Education and Experience Required:

  • MD or equivalent required with at least 5 years of experience in Clinical Research and Project Leadership in the Pharmaceutical or Biotech industries.
  • Experience leading a team in a cross-functional environment, preferably with global scope.
  • Strong scientific background in oncology drug development and experience designing and conducting oncology clinical trials.
  • Subspecialty training or significant experience in oncology and experience in both early and late phase development including regulatory interactions and submissions is preferred.

Required Skills and Abilities:

  • Ability to objectively exercise judgment and create pragmatic solutions to address complex cross-functional problems, obtaining stakeholder advice to make informed decisions, to move a program forward in the face of uncertainty or incomplete data.
  • Ability to lead and motivate team members from across functional areas; must be able to lead through influence and bring out the best in others. Ability to delegate appropriate accountability and decision-making to supporting teams and functions.
  • Strong collaboration, facilitative leadership, executive function, and problem-solving skills.
  • Ability and willingness to respectfully challenge team members and functions to assess fully all opportunities, options, risks, and mitigations.
  • Excellent oral and written English communication skills.
  • Strong understanding of and compliance within the pharmaceutical quality environment and attention to detail.
  • Demonstrated strong interpersonal skills, a flexible, collaborative and team-oriented approach to problem solving, and an ability to work and adapt in a fast-paced, rapidly changing environment.

Other Information:

NiKang currently anticipates the annual base salary range for this Vice President-level role is estimated to be from $345,000 to $390,000. Our job titles span more than one career level. The actual title for this role and final salary amount offered to a successful candidate may be higher or lower than the estimated range and will depend on several factors that include, but are not limited to, the geographic location of the candidate, the type and length of applicable experience, education, and other relevant factors. In addition to base salary, the hired applicant for this position will be eligible to receive an annual discretionary bonus and potential equity awards based on factors such as individual and organizational performance. NiKang offers a comprehensive benefit plan to eligible employees, including eligibility to participate in a company-sponsored 401(k) program, Paid Time Off benefits, eligibility for medical, dental, vision benefits, flexible benefits, short-term disability and life insurance benefits. NiKang reserves the right to amend, modify, or terminate its compensation and benefit programs at its sole discretion.

The statements contained herein are intended to describe the general nature and level of work to be performed. The statements are not to be construed as a complete and/or definitive list of the responsibilities, duties, and skills required of the employee. Furthermore, they do not imply a contract for employment and are subject to change with or without notice at the discretion of the employer.

Apply for job

If you meet the minimum qualifications for the role, please email a copy of your resume to careers@nikangtx.com and indicate the job title in the subject line.