Senior Director, Clinical Operations
Company: Crinetics Pharmaceuticals, Inc
Location: San Diego
Posted on: June 25, 2022
Job Description:
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otherwise. Position:Senior Director, Clinical Operations Location:
Remote or San Diego, CA
Job Id:369 # of Openings:1 POSITION SUMMARY: The Senior Director of
Clinical Operations will assist the VP in overseeing the
performance and management of Crinetics' clinical programs,
ensuring GCP and regulatory compliance, and managing the Clinical
Operations team. (Position will be filled at level commensurate
with experience) ESSENTIAL FUNCTIONS AND RESPONSIBILITIES: These
may include but are not limited to:
- Direct and oversee clinical programs to ensure compliance with
regulatory requirements, adequacy of data acquisition and
management, and timely completion of studies and associated
projects
- Identify and communicate project objectives, propose innovative
solutions to potential obstacles, and ensure adequate resources are
in place to successfully complete clinical projects and programs
on-time, on-budget, and with highest-quality deliverables
- Actively participate in development of clinical protocols and
program timelines
- Evaluate CROs for their ability to execute clinical trial work,
compare budgets and timelines, and make recommendations to senior
management; oversee preparation of requests-for-proposals and
facilitate bid defense meetings with potential vendors
- Coordinate with departmental and corporate management to ensure
appropriate fiscal oversight, including management of vendor
scopes-of-work and change orders
- Monitor enrollment activities and ensure optimal subject
recruitment for each project; Liaise with patient advocacy groups
to positively impact patient recruitment as needed
- Oversee vendor and site qualification activities in conjunction
with Clinical Quality Assurance
- Oversee management and maintenance of Trial Master Files for
all Crinetics' clinical trials
- Provide guidance on all logistics associated with execution of
clinical studies (including clinical supplies, sample shipments
etc.)
- Provide ongoing assessment and feedback on departmental
policies and procedures toward increased efficiency and quality of
deliverables. May contribute to the development of SOPs and other
procedural documents ADDITIONAL FUNCTIONS AND RESPONSIBILITIES:
- May be responsible for mentoring junior staff and/or direct
supervision and line management
- Other duties as assigned EDUCATION, EXPERIENCE, KNOWLEDGE,
SKILLS AND ABILITIES:
- BS in biological sciences or related discipline with at least
12 years of experience working in the biotechnology/pharmaceutical
industry (an equivalent combination of experience and education may
be considered)
- Prior experience managing third parties and external service
providers (worldwide) and consultants is a must
- In-depth experience with drug development issues
- Excellent writing skills as they relate to the preparation of
clinical and regulatory documents
- Excellent interpersonal skills with strong oral/written
communication and presentation skills
- Excellent negotiation skills and a tactful approach that leads
to high value on services obtained and outcomes achieved
- Experience in managing teams (including external service
providers and consultants)
- A good understanding of GLPs, GCPs, and ICH Guidelines
- Leadership and management skills, and, demonstrated qualities
in this area
- Demonstration of cross-functional understanding related to drug
development
- Good judge of risks and a keen ability to analyze options and
manage outcomes
- Familiarity of Regulatory Affairs as applicable to clinical
data and report filings
- Well versed with the latest trends in the clinical trial
industry TECHNICAL KNOWLEDGE REQUIRED: Equipment: PC, scanners,
facsimile machine, voice mail and e-mail systems, and common office
machines, or ability to be trained. Software Knowledge: Windows, MS
Office (Outlook, Word, Excel). EFFORT REQUIRED/ENVIRONMENTAL
CONDITIONS: Physical Activities: On a continuous basis, sit at desk
for a long period of time; intermittently answer telephone and
write or use a keyboard to communicate through written means. Some
walking and lifting up to 20 lbs. may be required. The noise level
in the work environment is usually low to moderate. The physical
demands described above are representative of those that must be
met by an employee to successfully perform the essential functions
and responsibilities of this job. Reasonable accommodations may be
made to enable individuals with disabilities to perform the
essential functions and responsibilities. TRAVEL: Travel may be
required up to 25% of your time ABOUT CRINETICS: Crinetics
Pharmaceuticals Inc. (www.crinetics.com) is a rare endocrine and
endocrine-related cancer therapeutics company. Crinetics' benefit
package includes health insurance, stock options, a 401k, paid time
off, and the company provides a dog-friendly work environment.
Keywords: Crinetics Pharmaceuticals, Inc, San Diego , Senior Director, Clinical Operations, Executive , San Diego, California
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