Medical Director (Clinical Development)

Employer
Agenus
Location
Lexington, Massachusetts
Salary
Agenus offers a competitive base salary, bonus plan, equity options and comprehensive benefits.
Closing date
Dec 15, 2021
You need to sign in or create an account to save a job.

The Medical Director (Clinical Development) leads and drives strategy for global clinical development taking into consideration the medical, scientific, regulatory, and commercial needs for Agenus’ pipeline.  This individual has the ultimate responsibility on one or more assets for development decisions, assessing and integrating input from various disciplines to create, maintain, and execute a global clinical development plan that will result in patient benefit and regulatory approval.

Responsibilities: 

  • Provides strategic leadership of the overall management, planning, evaluation and documentation of projects and studies.
  • Works closely with research and development, translational biology, and pre-clinical scientists to help guide new drug development, identify biomarkers, and patient populations likely to benefit from new therapies
  • Responsible for high impact global decisions: monitors and interprets data from ongoing internal and external studies, assesses medical and scientific implications, and makes recommendations that impact regional and global development such as “go/no go” decisions or modification of development plans or study designs.
  • Serves as an advisor to other clinical scientists involved in these activities and is accountable for the successful design and interpretation of clinical studies. Presents study updates and conclusions to Management and determines how individual study results impact the overall asset strategy.
  • Develops and writes clinical plans and protocols with the help of medical writing, ensuring scientific excellence
  • Prepares regulatory documents  for global regulatory authorities in collaboration with our regulatory department.
  • Analyzes, interprets and presents study data including integrated assessments from individual patients to composite data providing context with published clinical and scientific data.
  • Participates in the preparation of abstracts, posters and presentations for scientific meetings, congresses, and interactions with Key Opinion Leaders (KOLs).
  • Represents Agenus to KOLs and PI’s on Agenus studies with outstanding communication skills
  • Interacts and collaborates with pharmacovigilance, regulatory affairs, medical affairs, and clinical operations.
  • Oversees medical monitoring activities by assessing issues related to protocol conduct and/or individual subject safety in partnership with a CRO. Assesses overall safety information for studies and asset in conjunction with Pharmacovigilance. Oversees non-medical clinical scientists with respect to assessment of these issues.
  • Identifies and evaluates potential business development opportunities, conducts due diligence evaluations, and develops and negotiates clinical development plans for potential alliances and or in-licensing opportunities. 

Qualifications: 

  • MD or MD/PhD with Board Certification or eligibility in Hematology and/or Oncology with clinical practice experience and strong scientific competence demonstrated by peer reviewed publications or production of clinical expert reports.
  • Minimum of 3 years’ experience in clinical research required with experience in the pharmaceutical industry preferred, or deep expertise in oncology  (I-O is a plus) development in an academic research setting.
  • Experience interpreting clinical data and generation of supporting regulatory submissions of clinical study documents. Experience from the academic setting may be applied towards this experience.
  • Good communication and collaborative skills with experience working with cross-functional and external groups, including researchers, clinicians, and other stakeholders.                 
  • Experience interpreting clinical data and generation of supporting regulatory submissions of clinical study documents. Experience from the academic setting may be applied towards this experience.

 

Apply for Medical Director (Clinical Development)

Fields marked with an asterisk (*) are required

Your file must be a .doc, .pdf, .docx, or .rtf. No larger than 1MB
Selected file:

When you apply for a job we will send your application to the named employer, who may contact you. By applying for a job listed on ASCO Career Center you agree to our terms and conditions and privacy policy. You should never be required to provide bank account details. If you are, please contact us. All emails will contain a link in the footer to enable you to unsubscribe at any time.

You need to sign in or create an account to save a job.

Get job alerts

Create a job alert and receive personalised job recommendations straight to your inbox.

Create alert