Clinical Operations Associate Director (Biotechnology)

Exelixis Inc

Reference #: JR5591
SUMMARY/JOB PURPOSE:

The Clinical Operations Associate Director combines end-to-end design, execution, and reporting of clinical trials with leadership in study teams and across matrix teams. This position is accountable for planning and leading the delivery of studies to time, quality, budget, company standards and scientific requirements as outlined in the clinical study protocol. This involves generating robust and accelerated delivery plans (with a focus on performance) and delivering these to target or stretch thresholds. The Clinical Operations Associate Director is the Study Delivery Lead (SDL). The SDL is the study accountable person and the studies may span oncology products from early through to late phase of development and include delivery through one or more of in-house, outsourced and alliance delivery models. This role is highly visible within Global Clinical Operations and in the Product Matrix Teams. The SDL is the leader of the Study Management Team (SMT).
Please not this position requires a 5 day onsite presence for either our Alameda, CA location or King of Prussia, PA location.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Accountable for the global study delivery strategy (e.g., country selection, diversity, patient engagement strategy, recruitment plan, etc.) and for overall study deliverables.
Guide assessment, selection, engagement, management, and oversight of appropriate vendors.
Assure consent with ICH/GCP guidelines, all applicable laws and regulations, and Exelixis SOPs, for all products and services delivered for their designated studies.
Responsible for making decisions that balance risk/benefit with clear understanding of impact on the study and project; takes action to mitigate risk where appropriate.
Collaborate with matrix partners, Clinical Operations Program Lead and/or manager to develop and manage study level budget within project allocation.
Responsible for the preparation of materials for internal governance and / or financial review cycles.
Actively partner to build relationships and collaborate with aligned staff in other functions.
Encourage others within matrix and line teams to seek alternative perspectives and develop solutions.
Lead and conduct investigator meetings and other study related meetings and participate in governance meetings as necessary.
Identify and communicate resource gaps for assigned studies.
Lead risk management and quality efforts to ensure study compliance and continual inspection readiness.
Lead/contribute to ways of working and process improvement initiatives.
Provide expert clinical operational input into protocol development.
Partner with Data Management and Clinical Sciences to develop the data cleaning strategy for the study.
As the SDL, lead the SMT and actively partner to build relationships and collaborate with SMT
Work with the appropriate functions to develop patient centric documents and address patient burden.
Contribute to and engage Clinical Operations staff in process development, innovative problem solving, training initiatives as needed
Provide proactive and consistent oversight of CRO and vendor performance
Support Clinical Operations Program and / or Indication Lead with key study level status updates, with a particular focus on delivery to corporate and project level objectives.

SUPERVISORY RESPONSIBILITIES:
None, but as a Study Delivery Lead, this role will mentor junior Clinical Operations staff.

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:
BS/BA and a minimum of 11 years of related experience; or,
MS/MA degree in related discipline and a minimum of 9 years of related experience; or,
Equivalent combination of education and experience.
May require certification in assigned area.

Experience/The Ideal for Successful Entry into Job:
Experience in Biotech/Pharmaceutical industry preferred.
Management experience including outsourcing to Contract Research Organizat ons (CROs).

Knowledge/Skills:

Extensive clinical development experience with at least 6 years as a global study leader with proven experience in driving operational study delivery to time, cost, and quality within the pharmaceutical / biotech industry or CRO environment.
Proven operational experience of leading high performing global study teams in Oncology clinical trials.
Proactively identify and resolve issues to ensure timely study delivery to quality, timelines, and budget.
Excellent leadership skills, influencing and negotiation skills.
Demonstrated experience leading in the matrix environment to deliver projects, develop clinical plans and manage change.
In-depth knowledge of either study management or data management and knowledge of essential global regulatory guidelines and ICH/GCP.
Proven experience working with investigators, external experts and regulatory agencies and oversight of Contract Research Organizations and third-party vendors including realigning with CRO partners when deliverables are at risk, negotiating solutions and leading After Action Reviews to share lessons learned.
Ability to establish and build internal and external relationships at all levels in a highly dynamic and matrixed environment.
Excellent project management skills and budget management skills.
Possess competent written skills and experienced in authoring patient facing materials, study procedures manuals, pharmacy manuals, and informed consent forms.
Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways.
Interprets, executes and recommends modifications to companywide policies and/or divisional programs. May establish organizational policies in a major segment of the company.
Has extensive knowledge of other related disciplines.
Applies strong analytical and business communication skills.

JOB COMPLEXITY:

Has an in-depth knowledge of the functional area, business strategies and the companys goals.
Exercises separate judgment in methods, techniques and evaluation of criteria for obtaining results.
Exercises independent judgment in methods, techniques and evaluation of criteria for obtaining results.
Creates formal networks involving coordination among groups.
Serves as an external spokesperson for the organization.

EXHIBITS EXELIXIS LEADERSHIP COMMITMENTS:

We drive for results, so patients can survive and thrive.
We are resilient in the face of adversity, and tireless in advancing our science.
We celebrate our long history of prolific drug discovery and rigorous drug development.
We unite to launch innovative medicines for difficult-to-treat cancers.
We exist to give people hope – one drug, one patient at a time.
We are Exelixis.

LIVES THE EXELIXIS CORE VALUES DAILY:

Be Exceptional (Take the right action and lead others to do the right thing at the right time in the right way),
Exceed Together (Apply rigor, resourcefulness, and respect to maximize opportunities and deliver impactful results)
Excel for Patients (Innovate to design solutions and remove barriers to show how much we care)

WORKING CONDITIONS:

Travel may be required up to 20% in support of clinical study activities
#LI-JD1
If you like wild growth and working with happy, enthusiastic over-achievers, youll enjoy your career with us!

Our compensation reflects the cost of labor across severalU.S. geographic markets, and we pay differently based on those def

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