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Head, Clinical Development

New York

JOB SPECIFICATION

ROLE AND RESPONSIBILITIES

Summary Description
You will be responsible for development of international clinical plans (mainly in US and EU), the oversight and interpretation of clinical trials data and have clinical interactions with multidisciplinary scientists across the company including the CSO, COO and Chief, Clinical Operations. The position reports to the company’s Chief Executive Officer. The location of the position is in New York.

Essential Duties & Responsibilities

  • Devise strategy for, develop and implement clinical plans for drug
  • Interact with key opinion leaders to assure implementation of latest clinical thinking and guidelines into clinical development plans and company access to most current relevant industry developments
  • Develop regulatory strategy in response to regulatory guidelines and competitive intelligence in conjunction with project team members, regulatory affairs and senior management
  • Develop phase I-III clinical protocols in patients
  • Lead preparation of clinical portions of all relevant regulatory filings (such as IND/IMPD, BLA/NDA/MAA) and review sections from other functional areas
  • Work together with key opinion leader clinical investigators and coordinates their activities during the life of the clinical program and beyond
  • Develop strategy for and work with the company’s specialists within transplantation and the company’s advisory board to obtain strategic input into clinical program development
  • Work closely with other functional areas outside (CRO based) and within the company (clinical operations, data management, biostatistics, clinical pharmacology, preclinical) to facilitate the execution of clinical trials and programs
  • Serve as clinical (and medical) resource for clinical issues raised by internal and external collaborators, investigators, consultants and business development and investor contacts
  • Serve as lead clinical (and or medical) representative with regulatory agencies
  • Provide strategic input on new product concepts, long-range strategic plans and potential licensing opportunities
  • Has leadership role in collaborations with strategic partners.
  • Supervise and is accountable for the generation of and messaging in clinical program and regulatory submissions
  • Accountable for success of clinical development strategy
  • Represent the company at scientific, industry, regulatory, advocacy and financial community meetings and presentations, as well as other public relations opportunities.
  • Monitor clinical trials for safety and insure timely reporting of safety signals to regulatory authorities

QUALIFICATIONS

Core Competencies, Knowledge and Skill Requirements

MD in clinical immunology, allergy, autoimmune diseases, nephrology, transplantation or hepatology a plus but other specialties are considered, particularly those with expertise in clinical development in the field of transplantation

Demonstrated scientific and therapeutic expertise

Excellent written and verbal communication skills and proven ability to work in a collaborative environment

Five to ten years of pharmaceutical development experience; Clinical development of approved drug(s) is a plus; Five to ten years’ experience in transplantation drug development is preferred


Preferred Requirements

Experience with interactions with regulators and business partners preferred

Collaborative and flexible in personal interactions at all levels of the company

Ability to work proactively and effectively, with exceptional creative problem solving skills

Proven strategic planning and communication skills across multiple disciplines

Demonstrated ability to work with senior management in providing input to setting and executing on corporate objectives

Significant travel, up to 50% at some periods, required


Communication & Interpersonal Skills

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

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

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

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

MD in transplantation


Experience

Five to ten 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

1068

  • "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