Assoc. Director, Translational Medicine in South San Francisco, CA

$100K - $150K(Ladders Estimates)

Puma Biotechnology   •  

South San Francisco, CA 94080

Industry: Pharmaceuticals & Biotech

  •  

5 - 7 years

Posted 52 days ago

The AD/ Director, Translational Medicine, is a PhD trained Scientist and/or Clinical Scientist and responsible for overseeing all aspects of preclinical and translational research studies to help support or complement the clinical development of neratinib. The successful candidate will be accountable for the oversight and quality of pre-clinical study deliverables and work closely with academic collaborators and contract research laboratories as part of Puma Biotechnology's Investigator-Initiated-Research program. In addition, this person will act as a Clinical Scientist to support one or more clinical trials of neratinib and work closely with various members of the Translational Medicine, Clinical Development and Medical Affairs teams to gain input and ensure that studies are in alignment with development and commercial objectives. It is anticipated that this individual will supervise one or more Translational/Clinical Scientists.

Responsibilities may include some or all of the following:


Major Duties/Responsibilities

  • Plan, implement and manage pre-clinical collaborations with outside laboratories to deliver key experimental data to support clinical studies
  • Ensure that all pre-clinical collaborations are scientifically rigorous and support developmental, commercial and corporate needs.
  • Champion pre-clinical collaborations from inception and design to approval.
  • Effectively manage projects as part of a multidisciplinary team
  • Lead contact on assigned pre-clinical and clinical development project(s)
  • Champion pre-clinical collaborations from inception and design to approval.
  • Effectively manage projects as part of a multidisciplinary team
  • Effectively manage budgets and budget forecasts for all preclinical / translational studies
  • Review, interpret, and present pre-clinical and clinical data from development programs and the relevant literature at relevant governance and regulatory meetings, scientific congresses and advisory committees
  • Contribute to clinical and pre-clinical publications and presentations
  • Write and review Clinical Study Reports, and pre-clinical and clinical components of modules for the NDA, MAA and other regulatory submissions
  • Represent supported projects at scientific conferences and advisory committees
  • Leads interactions with investigators and cooperative groups
  • Other duties as assigned

Skills & Abilities

  • Proven ability to plan, implement and direct preclinical cancer research studies involving cancer cell lines, xenograft or PDX models
  • Experience with working with small molecules preferred
  • Deep understanding of cellular signal transduction pathways and targeted anti-cancer strategies
  • Must have excellent project management skills and managing multiple projects simultaneously
  • Preclinical study design and writing study reports
  • Excellent oral and written communication skills
  • Oversee the clinical management of 1 -3 drug products and programs
  • Must be skilled in functional and cross-functional people and project management
  • Must be fully knowledgeable and skilled in the development and writing of regulatory documents including:
  • IND
  • NDA/sNDA
  • IB

Physical Demands The physical demands described are representative of those that must be met by an employee to successfully perform the primary functions of this position.

The physical demands of the office are normally associated with extended amounts of time in front of a computer. While performing the duties of this job, the employee is frequently required to stand, walk, and sit. Travel as needed (up to 10% expected, including international travel)


Education & Professional Experience


Required

  • Advanced Clinical/Science Degree (e.g. PharmD, PhD, MSN, MPH)
  • Demonstrated experience in pre-clinical drug discovery research, and demonstrated strong acheivements in either the academic or industry settings
  • Minimum of 5 years pre-clinical development experience in the pharmaceutical or biotechnology industry
  • Knowledge of international regulations pertinent to current clinical development (eg ICH, FDA, EMA)

Other Requirements

  • Highly advanced oral, writing and presentations skills
  • Excellent project management skills
  • Communicates internally with senior management
  • Communicates externally with scientific congresses and advisory boards

Management of Staff

  • Up to 2 direct reports

Work Environment

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Valid Through: 2019-10-18