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Manager/Associate Director, Clinical Pharmacology Oncology

From: Yuhong Chen <chen.yuhong2010>
Date: Tue, 29 Sep 2020 20:22:53 -0400

Dear all,

An exciting opportunity at Haihe Biopharma, a global clinical stage
biopharma focusing on the discovery and development of innovative targeted
Oncology therapies. The company has multiple assets in clinical development
and a rapidly growing pipeline of innovative early stage assets entering
clinical trials globally, including multiple Phase I, Phase II clinical
trials in the US.



*Job summary:*

The role will provide Clinical Pharmacology and Pharmacometrics
contributions for the assigned projects. You will lead or work
collaboratively with other scientists in Clinical Pharmacology and cross
functionally with other groups within Haihe. Activities will include: devel=
op
clinical pharmacology strategy, author PK/PD related sections of clinical
trial protocols, draft PK/PD report in CSR for clinical studies, provide
clinical pharmacology support during SMC review and participate in project
team discussions. You will also lead submission efforts on the clinical
pharmacology section and interact with world health authorities regarding
submissions and subsequent queries. The position is Manager to Associate
Director level depending on the experience. To apply for the position,
please send your resume to yuhong.chen



*Key Responsibilities:*

· Serve as the Clinical Pharmacology expert on early and/or
late-stage and/or life-cycle project teams

· Manage and deliver relevant sections of clinical pharmacology
strategy, protocols, and clinical study reports by working with other
scientists in a matrix environment

· Analyze PK/PD data of FIH study and present in SMC meeting, pr=
ovide
clinical pharmacology support on dose escalation strategy, MTD
determination and RP2D selection

· Draft PK/PD report in CSR for clinical studies, including clin=
ical
pharmacology studies and phase I to III clinical trials

· Collaborate and/or perform modeling and simulation analysis of
pre-clinical and clinical PK/PD data to guide FIH dose prediction and/or
inform Phase 2&3 dose selection

· Interact with world health authorities including EOP1, EOP2 an=
d
marketing application related meetings

· Collaborative review and approval of clinical documents includ=
ing
IB, CSR, PIP, PSP, marketing application sections, health authority
briefing documents, and regulatory responses

· Coordinate and coauthor external presentations and publication=
s



*Qualifications*



*Education Required:*

   - MS or Ph.D. in Pharmaceutical Science, Clinical Pharmacology,
   Pharmacokinetics, Biomedical Engineering or a related field in the
   biological sciences



*Experience and Skills*

*Required:*

   - At least 3 to 5 years in combined industry, regulatory and
   postdoctoral experience in the field of Clinical Pharmacology and
   Pharmacometrics
   - Experience in the early and late stage development of small molecules
   and/or biologics is essential
   - Good hands-on skills in PK/PD modeling tools (e.g., NONMEM, Phoenix
   WinNonlin/NLME and R)



*Other:*

   - Team player works with others respectfully and cordially
   - The ability to adapt, work through conflicts, and persuasively
   influence outcomes.
   - Effectively cope with change and is comfortable changing direction and
   acting without

complete information

   - Demonstrated ability to develop and present sound proposals and
   recommendations and influence and motivate others to achieve objectives
   - Ability to develop and deliver effective presentations and
   written/oral communications.
   - Thrives in a fast-paced business environment
   - Willingness to work flexible schedule/hours



*Location:*

· US/China

· Home-based (US) or Shanghai China



*We provide competitive compensation package, including 401K, health
insurance and paid vacation days.*


Yuhong Chen, MD & Ph.D.

Executive Director

Head of Clinical Pharmacology

Haihe Biopharma

Email: yuhong.chen

Received on Tue Sep 29 2020 - 20:22:53 EDT

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