Vice President, Clinical Science

Company: Certara Inc.
Location: San Diego
Posted on: June 13, 2021

Job Description:

Job Overview:

The VP Clinical Science will be responsible for the establishment, growth, and management of the Clinical Science

Group within Certara's Integrated Drug Development Division

The VP Clinical Science will be responsible for assisting clients by bringing state of the art translational clinical

science approaches to therapeutic development strategy as well as advising clients in the use of cutting edge

clinical development strategies including the use of adaptive designs, RWE and the use of MBMA. The VP Clinical

Science will also support our asset evaluation team in the assessment of the clinical and safety aspects of programs

and projects.

Where required, the VP Clinical Science will provide guidance and expertise on all aspects of clinical safety

throughout the entire lifecycle of a product with special emphasis on ongoing evaluation of safety information

during clinical development.

Responsibilities:

Establish, grow, and manage Certara's Medical Science group througho

Recruitment of Clinical Scientists and Medical Directors

o Develop collaboration agreements with external groups to ensure medical support across a wide

range of therapeutic areas

o Development of Certara's network of external medical experts

Develop and promote Clinical Science service offerings and define Clinical Science components of cross

functional service offerings

Work with Business Development and Marketing to externally promote and sell Certara's Clinical Science

service offerings

Clinical therapeutic and safety evaluation on due diligence asset assessments

Provide clinical therapeutic input into clinical development strategies through

o Medical input into target product profiles

o In conjunction with cross-functional experts in Certara including Clinical Pharmacologists, identifying

appropriate translational medicine components of development including biomarkers/imagining

techniques to establish proof of mechanism, defining proof of clinical concept strategy and clinical

study design, exposure and dose response strategies in development, and identification of

approaches for personalized healthcare

o Advise clients in the use of cutting-edge clinical development strategies including the use of adaptive

designs, RWE and the use of MBMA

o Specification of medical aspects of study design and implementation of clinical protocols for first in

human studies through early proof of mechanism/proof of concept; including clinical development

plans, protocols, synopsis, full protocols, and contributions into Clinical Study Reports (CSRs)

o Provision of feedback and guidance into appropriate clinical end points to support both approval and

reimbursement, including patient reported outcomes, questionnaires, and health economic

considerations

Participate and provide clinical and safety input into regulatory interactions

Be subject matter expert for safety relevant discussions with regulatory agencies and other significant external

bodies

Be the accountable owner for all safety relevant content or safety relevant safety documents during clinical

development (e.g. DSUR, Development Risk Management Plans, Safety Analysis Plans) and post approval (e.g.

PSUR, RMPs, medical expert statements and answers to HA requests)

Provide clinical development input on all aspects of clinical safety, including trial design, appropriateness of

safety endpoints, analysis and interpretation of safety data

Perform the role of medical monitor on Phase I studies, as needed

Analyze and prepare efficacy and safety data for manuscript and/or publication submissions

Contribute to quality improvement: Review, prepare, and/or update local and global SOPs and working

instructions as required

Education, Experience, Training, and Knowledge:

Pharmaceutical Physician

Internal medicine trained physician with completed subspecialty training with pharmaceutical industry

experience in design of clinical trials

Drug Development experience in multiple therapeutic areas

3 + years of experience with due diligence assessments, clinical asset evaluations, and design of safety

studies

10+ years of experience as MD working on drug development programs in pharma industry or with

Contract Research Organization (CRO) or with experience within a Regulatory Agency with review of New

Drug Applications

Experience building and/or leading successful teams

Experience with clinical safety through pharmacovigilance and/or medical monitoring

Must have written experience with submissions and responses to regulatory agencies and health

authorities. Verbal experience a bonus.

Formal clinical training, including fellowship training, as well as translational/experimental medicine

expertise preferred.

Familiarity with concepts of clinical research and clinical trial design, including biostatistics and with the

application of model informed drug development

Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and

applicable international regulatory requirements

Skills & Abilities:

Distinctive ability to engage in discourse on innovative drug discovery from early preclinical through to

late-stage development

In-depth understanding of the scientific method and clinical applications based on medical, scientific, and

practical rationale

Ability to effectively present ideas and document complex medical/clinical concepts in both written and

oral communication

Strong ability to provide expertise across a range of therapeutic areas, with strength in at least one of the

following specialties hematology/oncology, pediatrics, inflammation, infectious diseases and/or global

health.

Possess a strong focus on influencing at high levels, innovation, and customer centricity

Strong initiative, self-motivation, and coordination with other team members

Demonstrated ability as a medical expert in a complex matrix environment

History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of

issues

Sound scientific and clinical judgment

OTHER INFORMATION:

Number of Employees Supervised: none - 10

Percentage of Travel Required: 10-20%

Certara bases all employment-related decision on merit, taking into consideration qualifications, skills, achievement, and performance. We treat all applicants and employees without regard to personal characteristics such as race, color, ethnicity, religion, sex, sexual orientation, age, nationality, marital status, pregnancy, physical or mental condition, genetic information, military service, or other characteristic protected by law.

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Keywords: Certara Inc., San Diego , Vice President, Clinical Science, Other , San Diego, California