Sr. Director, Clinical Pharmacology - US Home or Office Based
Posted on: August 17, 2019
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.
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.**
* 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
* Participates in business development initiatives and
independently generates business development leads.
* Prepares project proposals for prospective and existing
* 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.
* 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
* 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
* 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
* 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
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
* Health and Wellness comprehensive benefit package, wellness
programs, healthy lifestyle office environments
* Work/Life unlimited paid time off and an employee assistance
* Growth & Development performance driven environment
* Community Impact volunteering opportunities, matching gifts,
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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