19 days old

Global Clinical Lead Hematology (Non

Pfizer
Cambridge, MA 02139
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**Role Description**



+ This position will lead an asset or one or more indications for one asset within Oncology Clinical Development and will provide strategic and technical guidance at an asset and or indication level within Oncology Clinical Development, 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.



**Organizational Relationships:**

**Reports to:**



+ Hematology Global Clinical Leader



**Liaises with:**



+ Medicine Team Lead, Safety, Regulatory, Translational Oncology, Research, CD&O, and Commercial to support development efforts as needed.



**Resources Managed (budget and FTEs):**



+ Mainly matrix management responsibilities



**Responsibilities:**



+ Provide Clinical Development Leadership to Asset Teams



**Technical:**

**Contribution to Projects**



+ Accountable to deliver 2 or 3 large studies - related to execution and ability to bring in time lines; breadth of the program.

+ Single point of contact for Clinical Development to Medicine Team Leader for one or more indications or asset .

+ Leader of the Clinical Sub-Team related to assigned assets or indications.

+ 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 Hematology Global Clinical Leader

+ Signs off clinical documents as required by internal Guidance's/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.



**Management :**



+ Mainly matrix management responsibilities

+ Involvement in business and teaching others around due diligence



**Leadership attributes:**



+ Leads cross- department initiatives (e.g., Research, Safety Sciences, CD&O, Commercial) to support development efforts as needed.

+ Presentations to the TRIAD and GPDLT

+ 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.



**Qualifications (Training, Education & Prior Experience)**



Candidate demonstrates a breadth of diverse leadership experiences and cap

abilities 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:**



+ PhD with 10+ years of relevant industry experience, preferably oncology.

+ Clinical Development experience in industry or academic setting for Multiple Myeloma desir ed.

+ Demonstrated accomplishments or formal training in oncology.



**Prior Experience**



+ Demonstrated accomplishments or formal training in Oncology.

+ 5+ years of clinical development experience in the health sciences, preferably hematology, oncology.



**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.



**Other Job Details:**



+ Eligible for Employee Referral Bonus: YES



**Sunshine Act**

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.



**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.



Medical



\#LI-PFE
Posted: 2021-03-29 Expires: 2021-04-29
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Global Clinical Lead Hematology (Non

Pfizer
Cambridge, MA 02139

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