Country Therapeutic Area (TA) Director (Clinical Research), 2 positions Job

Employer
Merck
Location
Montreal (Kirkland), QC, CA
Posted
September 13 2017
Discipline
Other
Organization Type
Pharma
Country Therapeutic Area (TA) Director (Clinical Research), 2 positions-CLI006316

Description

Today’s Merck is a
global health care leader with a diversified portfolio of prescription
medicines, vaccines and animal health products. Today, we are building a new
kind of healthcare company – one that is ready to help create a healthier
future for all of us.

Our ability to excel depends on the integrity, knowledge, imagination, skill,
diversity and teamwork of an individual like you. To this end, we strive to
create an environment of mutual respect, encouragement and teamwork. As part of
our team, you’ll have the opportunity to collaborate with talented and
dedicated colleagues while developing and expanding your career.


This role
will be key to further develop the country capabilities in clinical research.
Under the oversight of the country or cluster CRD the person will be
responsible for the end to end performance of clinical trials in 1 or several
TA, from feasibility to close out. The role should be responsible for 30 to 50 clinical
trials and will ensure excellent study performance with strict adherence to
local regulations, Merck SOPs and ICH GCP.

The role is
responsible for oversight of all the employees working in the TA, with line
management for CRMs and functional oversight of other roles in his studies.

As line
manager the role is critical to develop key talents in the organization to
ensure a pool of success in critical roles.

The role will
work at country level with other local stakeholder like GMA, GHH, PV and
regulatory to ensure alignment and development of the country capabilities and
can represent the CRD of cluster in local management if required.

This position
is based at Head Office (Kirkland, Quebec).

Responsibilities include, but are not
limited to:

- Will
lead one or several TA of the growing portfolio in the country
- Accountable
for the successful execution, enrollment and quality of their clinical trial
portfolio
- Accountable
to ensure timelines and key milestones are met
- Accountable
for performance metrics
- Accountable
to develop operational strategies and quality plans for the conduct of all
programs and studies in the TA portfolio
- Collaborates
with other TA director, local and regional stakeholder in GCTO in order to
develop and build territory of principal investigators and sites
- Ensures
oversight and line management of Clinical Research Manager (CRM) team within TA
- Leads
team independently with supervision from CRD to high performance
- Accountable
for CRM performance reviews, including addressing low performance situations,
and taking appropriate actions
- Ensures
key talent development and retention
- Collaborates
and works closely with other stakeholders in the TA in GCTO & GCD regional
and headquarter teams, quality, finance,
IT and HR
- Collaborates
externally with investigators, regulators and vendors
- Member of the GCTO country leadership team
- Supports
strategic initiatives across Global Clinical Development GCD and GCTO
- Supports
local strategy development consistent with long-term corporate needs in
conjunction with CRD
- Together
with direct reports contributes significantly to effective conduct of clinical
studies and to develop the pipeline, while maintaining regulatory requirements
and compliance
- This
position impacts directly the country´s ability to reach business targets and
objectives and ensures that productive collaboration with internal and external
business partners are built
- Supervises
6-12 MSD employees and oversees contractor functions

Qualifications

- Bachelor’s
degree in Science or equivalent healthcare experience
- Advanced
degree, (e.g., MD, PhD, Pharm D, MS) an asset
- Minimum
of 12 years´ experience within Pharmaceutical Industry
- Minimum
of 10 years´ experience in clinical trial organization
- Minimum
of 3-4 years´ experience in a functional management position
- CRA
, project management and CRM experience, an asset
- Line
management experience, an asset
- Business
and financial acumen
- Strategic
thinking
- Ability
to think cross-functionally and working across boundaries internationally
- Ability
to identify problems, conflicts and opportunities early and lead, analyze
mitigation plans and drive conflict resolution is critical
- Sound
ICH-GCP knowledge and knowledge of Good Documentation Practices
- Good
understanding of Global, Country/Regional Clinical Research Guidelines and
ability to work within these guidelines
- Ready
to travel up to 30% of working time
- Excellent
communication skills
- Language: Bilingual, French and English (verbal and written)

Behavioral Competency Expectations:

- High
emotional intelligence
- Strong
leadership and negotiation skills
- Positive
proven success in people management
- Demonstrated
ability to build relationships with senior business executives
- Influencing
skills
- Excellent
interpersonal and communication skills, conflict management
- Relationship
management and networking: strong integration into local and HQ TA network and
ability to build productive relationships with all parties
- Effective
time management
- Effective
communication with external customers (e.g. sites and investigators)

Our employees are the key to our company's success. We
demonstrate our commitment to our employees by offering a competitive and
valuable rewards program. Merck's benefits are designed to support the
wide range of goals, needs and lifestyles of our employees, and many of the
people that matter the most in their lives.

Merck is an equal opportunity
employer, proudly embracing diversity in all of its manifestations.


Search Firm Representatives

Please Read Carefully:

Merck is not accepting unsolicited assistance from search firms
for this employment opportunity. Please, no phone calls or emails.
All resumes submitted by search firms to any employee at Merck via-email, the
Internet or in any form and/or method without a valid written search agreement
in place for this position will be deemed the sole property of Merck. No
fee will be paid in the event the candidate is hired by Merck as a result of
the referral or through other means.

Job: Clinical Research Generic

Job Title:Dir, Clinical Research

Primary Location: NA-CA-QC-Montreal (Kirkland)

Employee Status: Regular

Number of Openings: 1

Company Trade Name:Merck

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