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Sr. Director, Clinical Pharmacology - US Home or Office Based

Company: Certara
Location: Parsippany
Posted on: August 17, 2019

Job Description:

Certara is hiring a Sr Director, Clinical Pharmacology to support our Integrated Drug Development team! This position can be home or office based within the US.

About Certara Strategic Consulting

Certara Strategic Consulting is the largest pharmacometric organization in the world and assures that various career pathways are offered to match the ambition and personal interests of our employees! We are a division of Certara and deliver value by integrating advanced simulation approaches into the most crucial drug development deliverables to inform internal decision-making and strengthen global regulatory submissions. Leveraging our experience working on thousands of key drug development projects on behalf of hundreds of biopharma companies, we bring a track record of success and a broad range of expertise to each assignment.

Job Summary

As a Senior Director, Clinical Pharmacology, you will have a pivotal role in providing strategic clinical pharmacology guidance on drug development, use of quantitative methods such as modeling and simulations and regulatory writing capabilities, which provide unparalleled support to our clients. Our team includes thought leaders who are among the most well respected in our industry. If working alongside smart and driven colleagues sounds exciting to you, we want you on our team!

**We will consider any candidates that can work in one of our US based offices or remotely within the US.**

Main Responsibilities

* Supports and leads client early through late development, clinical pharmacology, pharmacometrics

* Collaborates with internal and client teams as a strategic advisor on regulatory, clinical development, clinical pharmacology, pharmacometric and another development issues.

* Leads client engagement teams.

* Support and lead technical due diligence engagements.

* Reviews and interprets client material.

* Identifies project opportunities, formulates teams, and identifies needs and resources necessary to execute projects as needed.

* Participates in business development initiatives and independently generates business development leads.

* Prepares project proposals for prospective and existing clients.

* Reviews regulatory publications to keep apprised of new regulatory developments and tracks recent regulatory approvals.

* Co/authoring peer-reviewed manuscripts and publications.

* Contributes to in-service training and mentoring for staff.

Essential Requirements

* PhD or PharmD or MD degree with specialization in pharmacology or pharmacokinetics, or in a related scientific discipline.

* Demonstrated track record in a functional leadership role on cross-functional drug development team.

* 12+ years working in project teams on the development of a broad range of compounds (eg. biologics, peptides, antibodies, antibody drug conjugates, cell therapies, small molecules, delivery devices, etc) from entry into human and beyond. Biologics experience a plus.

* Strong track record with regulatory interactions.

* Expert experience in providing input on clinical pharmacology plans and preparation of regulatory submissions (e.g. INDs, NDAs, BLAs and/or significant sNDAs/sBLAs).

* Must be recognized applied development practitioner, experienced in both design and stewardship of clinical pharmacology components of clinical development plans and optimal application of pharmacometric approaches to support decision making.

* Excellent written, verbal and inter-personal communications skills.

* Ability to mentor other junior scientist staff on clinical pharmacology science and strategy.

* Strong client and alliance management skills.

* Ability to work across functions to implement company initiatives.

* Advanced understanding of the application of a broad range of clinical pharmacology tools including but not limited to WinNonLin, Phoenix, NONMEM, S-Plus/R and other PK/PD analysis software.

* Must be able to work well with a team in a multidisciplinary environment.

About Certara

Certara is a growing company that provides a novel and exciting place to work. Our purpose is to assist in accelerating the development of meaningful medicines that make an impact on our society and the people that need them most. Innovation and creativity are highly valued, and everyone is given the opportunity for training and continuous development. Our portfolio spans the discovery, preclinical, clinical and post-marketing phases of drug development, working with 1,200 commercial companies, 250 academic institutions, and numerous regulatory agencies.

The wellbeing of our employees is a priority at Certara, and that is why we support the most important aspects of their lives:

* Financial competitive pay, incentives, retirement plans, income security programs

* Health and Wellness comprehensive benefit package, wellness programs, healthy lifestyle office environments

* Work/Life unlimited paid time off and an employee assistance program

* Growth & Development performance driven environment

* Community Impact volunteering opportunities, matching gifts, charitable contributions

Certara is an Equal Opportunity Employer. Certara does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.

Keywords: Certara, New York , Sr. Director, Clinical Pharmacology - US Home or Office Based, Healthcare , Parsippany, New York

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