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Head, Clinical Operations

New York

JOB SPECIFICATION

ROLE AND RESPONSIBILITIES

Summary Description:
The Head of Clinical Operations is accountable for strategic planning, oversight, execution of clinical programs. You must have the ability to work independently and as an effective and engaged team member in a fast-paced environment. Strong initiative and follow through are essential for this job. You will have clinical interactions with multidisciplinary scientists across the company including the CSO, COO and Chief Clinical Development.

Essential Duties & Responsibilities:

  • Oversight, management and guidance of phase I – III clinical programs to ensure highest quality, timeline and milestones, and budget goals are met
  • Develop efficient, scalable system approaches to planning and implementing clinical trial operations that effectively integrate clinical operations and other functional areas within.
  • Interact and collaborate with other management team members as appropriate.
  • May present Clinical Operation updates to the executive team and to the Board
  • Responsible for the strategic resource management of in-source/out-source study requirements
  • Evaluate and select service providers (often in collaboration with the company’s COO) and manage these resources effectively
  • Perform other duties as assigned.

QUALIFICATIONS

Core Competencies, Knowledge and Skill Requirements

Have the ability to evaluate and resolve complex problems

Excellent verbal and written communication skills

Must have a thorough knowledge of clinical research concepts, practices, and FDA/EMA regulations and ICH Guidelines regarding drug development phases, clinical research and medical affairs trials, clinical study design, and data management methods.

Self-motivated to maintain expertise in regulatory requirements and guidance to ensure that the Clinical Operations remains compliant with GCP and other global regulatory guidelines or laws

Experience with global drug development and BLA/NDA/MAA filing is preferred

Experience in developing protocols, SOPs, Clinical Study Reports, INDs and IMPDs, BLA, MAA and NDAs, as well as other clinical, regulatory, and safety documents

Proven experience handling confidential and sensitive information with the ability to exercise discretion and show good judgment; honesty, integrity, and trust building behaviors in all dealings is essential and required.

Daily demonstrates a positive, ‘can do’ and service-oriented attitude; detail-oriented with a commitment to accuracy.

Self-motivated, with initiative and the ability to take ownership of, and follow through with, specific tasks and to meet preset and to meet deadlines.

Ability to multi-task and shift priorities quickly while working under tight deadlines.

Required skill in the operation of standard office equipment including: fax machines, copy machines and other equipment as necessary.

Strong PC experience and demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint).

Able to travel as required by business needs


Communication & Interpersonal Skills

Excellent verbal and written communication skills, as the position will interface potentially key opinion leaders and employees at the company.

Ability to effectively communicate, collaborate and deliver an excellent work product in a fast-paced, and rapidly growing dynamic company.

Dynamic and innovative skill with a well-developed sense of teamwork.

The company is a fast-moving small-medium company, with a sense of urgency around what we do, and a successful colleague can manage ambiguity and uncertainty successfully, and can develop and execute project plans within a busy environment


REQUIREMENTS
Education

Bachelors in Life Sciences, Nursing Licensure or Pharmacy; an advanced degree (MS or PharmD) is preferable


Experience

Eight or more years of clinical trial experience in a similar role at a pharmaceutical, biotechnology or CRO company

Ability to effectively manage multiple clinical projects concurrently


Travel, Physical Demands And Work Environment

Regularly required to operate standard office equipment

Ability to work on a computer for extended periods of time

Regularly required to sit for long periods of time, and occasionally stand and walk

Regularly required to use hands to operate computer and other office equipment

Close vision required for computer usage

Occasionally required to stoop, kneel, climb and lift up to 20 pounds

ADDITIONAL NOTES

1067

  • "BioSearch has the experience, network, and know how to identify, recruit and secure top industry talent. I have seen the quality of individuals brought through them into organizations and, as well, have had the privilege of their representation as a candidate. They are consistently of the highest integrity; are tremendous communicators; and seek to optimize process, match and retention to the benefit of all. I give them my highest and unreserved recommendation." -  Todd Yancey, MD - Senior Vice President, Clinical Development – Immuno-Oncology, BeiGene

  • "Working with the BioSearch team has enabled us to build a strong, cohesive group at Gritstone Oncology. They understand who we are, and how we work, and tailor the candidate selection accordingly. Searches are consequently efficient and effective."

    - Andrew Allen, MD, PhD - President and CMO, Gritstone Oncology

  • "When BioSearch says that they have a great candidate for us to consider, I can absolutely count on that to be the case. Our mutual respect for each other has meant that their candidates already arrive for their interview with a positive impression of Sierra as a preferred place to work."

    - Barbara Klencke, MD - Chief Development Officer, Sierra Oncology

  • "When it comes to recruiting companies, I give my highest recommendations to BioSearch. I have worked with them for many years as a client. They consistantly provided high quality candidates for our open positions, greatly reducing our recruiting and hiring timelines. I recently entrusted them with my own career search which resulted in a position that exceeded my expectations."
    - Jeff Knight, PhD -  Vice President, Clinical Operations, Halozyme Therapeutics