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|Colorectal Cancer Global Clinical Lead, Executive Director|
Location: Cambridge, CA
Employment Type: Full Time
Date Posted: 02/20/2021
Expire Date: 05/24/2021
Job Categories: Advertising/Marketing/Public Relations, Biotechnology and Pharmaceutical, Government and Policy, Healthcare, Practitioner and Technician, Human Resources, Legal, Sales, Research & Development, Medical, Writing/Authoring
Colorectal Cancer Global Clinical Lead, Executive Director|
+ This position will be responsible for vision strategy in colorectal cancer/melanoma and will lead agents within Oncology Clinical Development providing strategic and technical guidance, as well as coordination and support to Medical Monitors and non-MD clinicians in CD&O.
+ Provides therapeutic area clinical expertise to a project(s) and maintains state of the art knowledge in Therapeutic Area.
+ Provides oncology expertise to the project team to enable clinical interpretation of study data.
Provide Clinical Development Leadership to Asset Teams:
+ Scientific Expertise & Recognition : high impact publications, key external presentations, recognized as subject matter expert internally and sought out for advice.
Contribution to Projects :
+ Accountable to deliver 2 or 3 large studies - related to execution and ability to bring in time lines.
+ Single point of contact for Clinical Development to Medicine Team Leader for one or more indications or asset Chairs the Clinical Sub-Team.
+ Leads design, implementation, and interpretation of part of the global clinical program (one or more indications) for a drug candidate to deliver a successful regulatory submission worldwide, working closely with the Clinical Development Leader.
+ Ensures alignment of regional clinical development strategy with global strategies for the indications he or she is responsible for.
+ Contributes to development strategy, by creating and updating the clinical development plan which should integrate well-designed studies with the most efficient use of budget and resources, and risk and quality assessment.
+ Leads the preparations of the clinical content of regulatory submissions/documents (e.g. NDA, MAA, IND, sNDA, IB, AR/DSRU, label changes, Core Data Sheet, Package Insert) under supervision of the Clinical Development Leader.
+ Signs off clinical documents as required by internal Guidances/SOPs.
+ Leads discussions with regulators and with the resolution of clinical queries from drug regulatory agencies; leads or contributes to writing and review responses to regulatory queries.
+ Provides clinical input in the preparation and execution of meetings with health authorities.
+ Maintains and enhances knowledge in relevant therapeutic or technical areas and in global regulations/guidelines.
+ Provides clinical strategy/input to product teams to support marketing and product enhancement/ differentiations efforts, as needed.
+ Maintains state of the art knowledge in the tumor-specific therapeutic area.
+ Creates and maintains a network with key opinion leaders.
+ May organize expert panel, consultant or advisory board meetings to provide input to clinical plans.
+ May be an active member of an alliance partnership team.
+ May present to senior management, governance committees and external audiences on the clinical aspects of compound development, including milestones, strategies and data, as appropriate.
+ Supports licensing initiatives, as appropriate, and as such may design/conduct/review protocols as a member of licensing team.
+ Represents the Clinical line on the Publication Sub-Committee and contributes to designing the publication strategy for the asset(s).
+ Represents the clinical line on project-related teams and cross-divisional committees.
+ Reviews ISR proposals.
+ Interfaces with other Pfizer sites, other TAs and other functions to share best practices, as appropriate.
+ Mainly matrix management responsibilities.
+ Involvement in business and teaching others around due diligence.
Leadership attributes :
+ Mentorship: track record of developing others; sought out by more junior colleagues as a mentor.
+ Excellence in leadership within the GMT, leading the CMT and consistent with Pfizer values.
+ Leads cross- department initiatives (e.g., Research, Safety Sciences, CD&O, Commercial) to support development efforts as needed.
+ Presentations to the TRIAD and GPDLT.
+ Career maturity and growth supervisory role, role in business development.
+ Significant degree of independence, willing to take on special projects; unique study designs such as incorporating RWE.
+ Registration and submission experience (absolute requirement).
Development and Fostering of Clinical Development Best Practices :
+ Develop and promote an effective network within the Pfizer Global Product.
+ Development community, ensuring sharing of knowledge and best practices.
Provide key communications :
+ Review abstracts, posters, and presentations and ISRs for his/her responsible asset(s) for scientific meetings.
+ Communicate regularly with Medical Monitors and non-MD clinicians with regard to study status and other clinical activities, escalating unresolved issues to the Clinical Development Leader.
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
**Training and Education:**
+ MD or MD/PhD
+ Board certified/eligible in Oncology or equivalent qualification.
+ Demonstrated accomplishments or formal training in oncology.
+ Demonstrated accomplishments or formal training in Oncology.
+ 8+ years of clinical development experience in the health sciences, preferably oncology.
+ 5+ years pharmaceutical industry experience (minimum depending on academic experience prior to industry).
**Key Competencies and Characteristics:**
+ Proven ability to lead a team in a complex matrix environment.
+ Demonstrated business acumen.
+ IND/NDA/MAA submission experience.
+ Acts decisively.
+ People management experience.
+ If MD, active medical license.
**Other Job Details:**
+ Eligible for Employee Referral Bonus: YES
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**EEO & Employment Eligibility**
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.