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AD/Director/Sr. Director role in bay area biotech

From: Brenda Roseberry <broseberry>
Date: Mon, 2 Nov 2020 21:24:11 +0000

NEW!!clinical pharmacology role with a biotech in the bay area. Very exciti=
ng work and science, whomever takes this role will be the head of clin phar=
m and eventually grow the group. Level is flexible between AD/Dir/Sr. Direc=
tor, please let me know if you would like to discuss or have a referral.

The head of clinical pharmacology will develop biologics with novel molecul=
ar formats to engage and activate immune cells for the treatment of cancer =
and other diseases. With multiple programs in clinical trials, we are recru=
iting a highly motivated scientist to head the critical function of clinica=
l pharmacology. To support the advancement of the Company's clinical pipeli=
ne, the successful candidate will be the leader in building the department =
of clinical pharmacology.

  * Lead the Company's clinical pharmacology group.
  * Act as the subject matter expert and a key stakeholder in product dev=
elopment teams (PDTs); collaborate across functional groups to advance the =
Company's late stage research and clinical programs.
  * Recruit junior clinical pharmacologists and provide adequate support =
for drug development programs.
  * Apply state-of-the-art quantitative) methods in modeling and simulati=
on based on nonclinical data and evolving clinical data.
  * Develop strategies and direct efforts in clinical pharmacology to mee=
t regulatory requirements as development molecules move through advancing p=
hases of clinical trials.
  * Manage CRO's and vendors to implement and validate methods, manage sa=
mple analysis, develop data transfer plans, organize and interpret data, an=
d present analysis to key stakeholders (PDTs, senior management, and board =
of directors).
  * Present findings in the forms of scientific meeting abstracts, poster=
s, and manuscripts.
  * Author documents for regulatory submissions.

  * A PhD with 6-15 years of experience in clinical pharmacology modeling=
 and simulation in the biotech/pharmaceutical industry.
  * Demonstrated experience, proficiency, and track record in running and=
/or overseeing clinical pharmacology programs in clinical trials.
  * Manage QSP work being done by vendors
  * Excellent communication skills, especially the ability to explain com=
plicated principles of QSP and biologic meaning of modeling/simulation to l=
ay audience.
  * Well-informed in regulatory guidance, requirements, and expectations =
in the US and internationally.
  * Knowledgeable in the significance and relevance of common clinical pa=
thology and hematology endpoints to the pharmacological effects of cancer t=
herapeutic agents.
  * Previous experience in biologics and working knowledge in the human i=
mmune system and lymphocyte functions relative to development of immuno-onc=
ology drugs are major pluses.

Brenda Roseberry
   Division Manager-Scientific
   Preclinical/Clinical--PK, Pharmacology, Pharmacometrics, Biomarkers
    720-328-9526 - Office
    315-415-4353 - Mobile (preferred)
    720-475-1176 - Fax

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Received on Mon Nov 02 2020 - 16:24:11 EST

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