Director, Clinical Pharmacology

Location
Cambridge, MA, United States
Posted
Nov 02, 2018
Ref
R-00846
Hotbed
Genetown
Required Education
Doctorate/PHD/MD
Position Type
Full time
Title:
Director, Clinical Pharmacology

Company:
Ipsen Bioscience, Inc.

Job Description:

Under the leadership of the Head of Clinical Pharmacology, the Clinical Pharmacology Director is responsible for leading the Clinical Pharmacology program and strategy forOncology compounds and Radiopharmaceuticals by:
  • defining and implementing the Early Development/Clinical Pharmacology Plan to support the registration dossier,
  • providing scientific and operational support to the Early Development studies (first-in-human, proof of concept) and late-phase Clinical Pharmacology studies (drug-drug interactions, special populations),
  • aligning plans and strategies with partner line functions and internal or external stakeholders,
  • Interacting with Health Authorities.


The Clinical Pharmacology Director is accountable for the early drug development and translational strategy within the Project Team, and for the clinical study protocols and their operational implementation within the clinical Study Team.

Main Responsibilities and main Tasks
  • Early Development/Clinical Pharmacology Strategy
  • In close collaboration with internal and external key stakeholders, define the Early Development/Clinical Pharmacology Planand registration strategy for Oncology compounds and Radiopharmaceuticals,
  • Provide input on study design for Early Development studies (first-in-human, proof of concept) as well as late-phase Clinical Pharmacology studies (drug-drug interactions, special populations),
  • Contribute to the appropriate use of biomarkers in Clinical Pharmacology studies with a focus on Oncology and Radiopharmaceuticals,
  • Contribute to the preparation of regulatory components Clinical Trial Applications (IND, IMPD, IB) and any other regulatory submissions (summary documents),
  • Attend meetings with external stakeholders (investigators, KOLs) and Health Authorities.
  • Project Team Member
  • Represent the Clinical Pharmacology function in Project Teams and endorse accountability for Clinical Pharmacology deliverables,
  • Liaise with key partner line functions to identify potential project hurdles, provide solutions and contribute to contingency plans,
  • Responsible for the timely and effective communication of strategy and results to the Project Team by efficient communication.
  • Clinical Study Team Member
  • As a core member of the Clinical Study Team, provide guidance for the design and successful execution of Early Development and Clinical Pharmacology studies,
  • Participate in the identification and the evaluation of clinical trial sites and CROs,
  • Contribute to the clinical study design, author clinical study protocols and clinical study reports,
  • Review and evaluate clinical study data, provide scientific input for their interpretation and adaptation of further development steps (data driven )
  • Prepare and attend meetings with investigators, external experts and Health Authorities.
  • Scientific expertise and organizational excellence
  • Contribute to the evaluation of licensing-in opportunities with a focus on Oncology and Radiopharmaceuticals,
  • Contribute to the department working standards,
  • Strictly adhere to GxP guidelines, SOP and other working practices, as appropriate,
  • Actively participate in internal workstreams and cross-functional or cross-departmental initiatives.


Experience/Qualifications

Ideal: MD, and/or PhD in pharmaceutical sciences/pharmacology, or PharmD, with at least6years of industry experience in Oncology and/or Radiopharmaceuticals (early development translational studies and/or late phase development with a track record of Clinical Pharmacology contributions to projects or submissions). Demonstrated success in a matrix leadership role.

Minimum: PhD in pharmaceutical sciences/pharmacology or other relevant life sciences, or PharmD with relevant experience in pharmacology, drug development in an industrial setting.

Language : English (Fluent).

Required Competencies

Experience in the development of Oncology compounds and/or Radiopharmaceuticals

Clinical Pharmacology strategy in drug development and registration

Regulatory knowledge (early- and Late-phase clinical drug development)

Data driven mindset

Excellent communication skills

Adaptive, flexible

Problem solving capability

Good organizational skills

Team Spirit

IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.