This site uses cookies. To find out more, see our Cookies Policy

Head of Clinical Operations, 896952 in Cambridge, MA at Apex Life Sciences

Date Posted: 11/28/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Cambridge, MA
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    11/28/2018
  • Job ID:
    896952

Job Description


Head of Clinical Operations, 896952

Job Scope & Purpose:

Our client is a patient-focused, innovative immunotherapy company dedicated to developing a novel, proprietary class of biologics engineered to selectively modulate the human immune system and treat a broad range of cancers and autoimmune disorders. These biologics are designed to engage directly with and modulate the activity of, disease-associated T cells in patients, potentially offering significant therapeutic advantages while minimizing or eliminating unwanted side effects.

The successful applicant will have a strong scientific background and leadership experience in late-stage nonclinical (IND enabling) and early clinical development.  Preferred experience on cross-functional teams coordinating and managing activities with external partners, clinical sites and investigators to initiate and conduct early phase oncology clinical trials.

Primary Job Responsibilities:

  • Provide strategic input to the development of an optimal clinical development plan (CDP) providing input to challenge the team with respect to risk management and the business value assessment.
  • Ensure internal and external alignment and timely execution of the CDP, while providing a constructive and challenging critique (risk management/business value assessment).
  • Operational implementation of clinical development programs within timelines, budget and company standards. These include trials from Entry Into Human through phase II studies as well as clinical pharmacology and experimental biomarker studies.
  • Membership of clinical team and biology project teams for one or more early development molecule, providing operational input to the definition of project strategy and feasibility of execution.
  • Accountable to the biology project team for timely and accurate forecasting and delivery of operations project resource and budget, for  planning, tracking and managing the operational budget, resources (allocation) and timelines for the project against the agreed goals of the team. 
  • Effective collaboration with the appropriate internal functions in defining the resourcing and the outsourcing strategy for the early development programs. As needed, assume leadership of project sub-teams e.g. Clinical Team. Ensure project implemented according to ethical/regulatory/legal requirements.
  • Accountable for the selection of the clinical CRO for the phase I trial and oversight of CRO activities and effective collaboration with CRO and clinical investigator team - different levels of responsibilities and accountabilities may be assigned to take account of the skills capabilities and experience of the individual.

About Stratacuity: 

Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.

PROVEN SCIENTIFIC PLACEMENT™ 

Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us at info@stratacuity.com or 877-787-2821.

Code: ClinOps

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.




896952