Clinical Operations Head Oncology

Pfizer Collegeville , PA 19426

Posted 2 months ago

The Clinical Operations Head Oncology (COH) is the leader of a best in class clinical operations group with accountability for the operational delivery of all global clinical studies within the Oncology category from first in patients through to loss of exclusivity, and a member of the CD&O Leadership Team. They will act as the key Clinical Development and Operations (CD&O) strategic partner to the Chief Development and Chief Scientific Officers within the category ensuring that the respective portfolio is appropriately prioritized, resourced and delivered according to agreed strategy, timelines and budget. The COH will lead a group of up to 50 clinical operations leaders and colleagues distributed across Pfizer sites and virtual / global locations.

The COH is held directly accountable by the head of CD&O for the operational delivery of the portfolio of studies within a therapeutic category. The oncology portfolio of work approximates to between 5,000 to 12,000 active patients at up to 2000 Pfizer Clinical Development sites across the world.

The COH will inform, influence and drive decisions in a given therapeutic category through the application of quantitative, data driven operational planning and execution and by active participation at, and leadership of, major governance meetings.

In partnership and close collaboration with other COH's and functional lines within CD&O s/he will be responsible for leading the identification, development and implementation of clinical operations standards, processes and industry leading best practices. The COH will be held accountable for the thoughtful adoption and utilization of digital and innovation within their portfolio.

The COH will set the highest expectations for quality and operational excellence, fostering a culture of continuous improvement and inspiring Clinical Study Team Leads (CSTL) to lead with purpose and deliver against Pfizer's strategic imperatives. S/he will actively engage in talent development and provide the structural and cultural framework for the development of team leaders, realizing the potential and maximizing the impact of the CSTL role.

S/He safeguards the safety and wellbeing of trial participants through the provision of high-quality operational oversight and is a

point of escalation for operational quality issues arising from sites and the development of associated CAPAs.

ROLE RESPONSIBILITIES

  • Serves as the as the single point of accountability for the operational delivery of a portfolio of clinical studies and regulatory submissions consistent with the requirements of the clinical development plan.

  • Identifies, leads and implements industry leading best practices for the conduct of clinical trials within their therapeutic category.

  • Drives a culture of continuous improvement and a workforce that excels in clinical project management execution

  • Sets expectation, secures resources and holds CSTLs accountable for the delivery of clinical studies to the highest quality standards, against agreed timelines and within assigned budget.

  • Accountable to ensure CSTLs are effectively leading study teams through various stage gates, ie. FIH, FIP, POC, PSS, DP3 and Quality Gates etc as well as overseeing the quality and accuracy of data input for management reporting on study performance.

  • Ensures risk management and risk mitigation strategies are in place and implemented for all studies in respective portfolio.

  • Ensures Therapeutic Area deliverables align with Pfizer/industry leading standards on quality, speed and cost for clinical plan operationalization

  • Holds CSTLs accountable for ensuring study teams are inspection ready at all times.

  • Influences and informs clinical development strategy, portfolio prioritization and budget allocation through clinical operations input to therapeutic categories.

  • Inspires, motivates and engages operations colleagues, providing clarity of purpose and sets expectations of operational excellence, and continuous improvement.

  • Develops talent management plan and provides infrastructure and support for continued professional development.

  • Collaborates within CD&O and across GPD to develop, prioritize and support leadership team activities.

  • Ensures compliance with all applicable regulatory, operational and technical requirements, including global and local training requirements and adherence to relevant global / local SOPs assigned to roles.

Education

  • Bachelor's Degree required

  • Advanced degree or professional certification in a health care related, scientific or technical discipline preferred.

Experience

  • At least 15 years of experience and track record of success in biopharmaceutical industry in clinical research and development

  • Extensive knowledge of clinical development, global and regional regulation, ICH/GCP, adverse event management

  • Demonstrated clinical/medical, administrative, and project management capabilities, as well as effective verbal and written communication skills in relating to individuals both inside and outside Pfizer

  • Demonstrated experience managing and training large teams in clinical development

  • Demonstrated experience in designing and launching large teams preferred

Competency Requirements

  • Scientific credibility/Operational Excellence/Project management acumen
  • Track record of achievement in pharmaceutical development, able to coordinate and execute clinical development or lifecycle strategy. Demonstrated understanding of the complexities and recent developments in the principal disease areas; confident discussing scientific / mechanistic aspects of drug development, as they relate to operational excellence for studies in their therapeutic area
  • Management experience
  • Able to set priorities and manage cross-functional teams and complex projects to deliver milestones according to set budgets; sets priorities; able to define and manage appropriate resource requirements (budgets and FTEs) both in-house and vendors / contractors
  • Leadership
  • Persuasive and effective leader of staff
  • Influencing
  • Able to manage and motivate internal teams in clinical trials
  • Conflict Management
  • Able to act as mentor / coach to others to improve conflict management skills; steps up to conflicts, seeing them as opportunities; reads situations quickly; can hammer out tough agreements and settle disputes equitably; prepared to take responsibility for a decision made and support this, even though it may be unpopular
  • Recognizing and Developing Talent
  • Good judge of talent; can articulate strengths and limitations of people; provides challenging tasks and assignments, holds frequent development discussions; is aware of each person's career goals and constructs compelling development plans; is a people builder.
  • Team Building
  • Shares wins and success; fosters open dialogue; lets people finish and be responsible for their work; defines success in terms of the whole team; creates strong morale and spirit in his/her team; creates a feeling of belonging to the team
  • Accountability
  • Take personal responsibility for results, pushing self and others to exceed goals and deliver results
  • Change agile
  • Able to demonstrate perspective and poise in the face of uncertainty and effectively get things done amidst organizational change

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Global travel required

Other Job Details:

  • Last Date to Apply for Job: October 16, 2020

  • Eligible for Relocation Package Yes

  • Eligible for Employee Referral Bonus Yes

  • #LI-PFE

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

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Medical Director Oncology Clinical Development Bcma Combinations

Glaxosmithkline

Posted 2 months ago

VIEW JOBS 10/17/2020 12:00:00 AM 2021-01-15T00:00 Site Name: USA - Massachusetts - Waltham, USA - Pennsylvania - Upper Providence Posted Date: Oct 15 2020 GSK oncology is committed to the discovery and development of new oncology therapies that leverage patient-driven science to deliver improved outcomes for more patients. Are you keen to take your career to a level of recognition and greatest impact on a leading oncology asset at GSK? Then this Medical Director-Oncology Clinical Development position supporting BCMA on the Immuno-Oncology team is one to consider. Why you? GSK is expanding its Oncology organization, and we are looking for experienced professionals to help us rebuild and grow our internal expertise! We have an exciting (and expanding) portfolio, and are looking for a Medical Director to transform delivery of our Oncology clinical studies. It's a wonderful time to join our team as we discover and develop new oncology therapies with the life-changing potential of helping patients with cancer, specifically in three areas of cancer research: Cancer Epigenetics, Immuno-Oncology, Oncology Cell Therapy and Synthetic Lethality. Within the I-O strategic research area of GSK Oncology R & D, the Medical Director- BCMA is accountable for the clinical development of one the leading Oncology assets in Immuno-Oncology (IO): anti BCMA antibody drug conjugate (ADC), GSK2857916. The candidate will be responsible for leading clinical study team consisting of clinical scientists and other function representatives, strategizing development plan, executing clinical trial(s) in multiple myeloma and related diseases, and managing the development study resources and timeline. This role requires a cross-matrix leader to contribute to an integrated strategy across different indications for GSK'916, and to combination strategies with various internal and external assets. Clinical Development at GSK is responsible for the development of the oncology portfolio from First Time In Human (FTIH) clinical trials to Proof-of-Concept studies, and pivotal registration trials. As GSK'916 is completing early phase development and transitioning into pivotal trial stage, this is an exciting opportunity to be instrumental in the success of this asset and to provide benefit to cancer patients. Candidate will be accountable for the design of clinical trials, and for medical governance for clinical studies; development of high quality clinical plans and data analysis strategies that encompass appropriate imaging, biomarkers, surrogate endpoints, and enabling technologies. https://www.lifescienceleader.com/doc/building-gsk-oncology-r-d-0001 \ASCO 202: https://us.gsk.com/en-us/gsk-at-asco-2020/ The Job: The Medical Director as a study physician will be responsible for clinical research activities pertaining to advancing the development of GSK's clinical portfolio and will also have responsibility for engaging in medical dialogues with relevant scientific and medical leaders in order to lead clinical data generation activities. This individual will also have a leading role in managing effective relationships with Key Opinion Leaders. Job Responsibilities: * Collaborate with physicians, scientists, regulatory professionals, biostatisticians, regulatory, executive staff and others as necessary to development and execute clinical trials from beginning to end. Contribute to ongoing or planned interventional clinical trials (phase 1-3) * In collaboration with clinical teams, drive clinical trial execution to achieve timely completion of clinical studies. * Assume medical responsibility for clinical trials including active participation in real-time medical monitoring of studies, including patient eligibility assessment, study design questions and safety data review. * Conduct safety monitoring in collaboration with CRO pharmacovigilance group of active clinical studies. * Analysis, interpretation and presentation of clinical study data. * Collaborate with colleagues in Regulatory Affairs, CMC, Toxicology, Research, Pharmacology to respond to health authority and ethics committee queries. * Participate in clinical study report writing and review, using medical expertise to identify ways to best analyze and present data * Collaborate with Principal Investigators in the evaluation and assessment of publications (abstracts, posters, manuscripts) associated with clinical data. * Network extensively to develop long-term strategic partnerships with thought leaders both internally and externally, in support of GSK's vision. * Represent GSK at medical meetings, advisory boards and outreach meetings as needed/appropriate. . * LI-GSK Basic Qualifications: * MD (or equivalent) with board certification or board qualifications in medical oncology. * At least 3 years of clinical development experience within the pharmaceutical or biotechnology industry with focus and strong track record of experience with leading oncology clinical trials. * Academic oncologists with strong clinical and research experience in hematologic malignancies will be considered. * Strong working knowledge of the clinical drug development process Track record in the conduct/participation in clinical trials (investigator initiated, company sponsored or cooperative group trials) and their subsequent publications. * Successful academic research publication history or history of medical practice in a relevant field. * Solid personal and professional relationships with key opinion leaders (KOLs) in medical oncology. Strong credibility within the US medical community which includes the ability to reach out to key thought leaders in academia. Preferred Qualifications: If you have the following characteristics, it would be a plus: US State License to practice medicine is desirable. Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: * Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk. * Managing individual and team performance. * Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. * Implementing change initiatives and leading change. * Sustaining energy and well-being, building resilience in teams. * Continuously looking for opportunities to learn, build skills and share learning both internally and externally. * Developing people and building a talent pipeline. * Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation. * Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally. * Budgeting and forecasting, commercial and financial acumen. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site. Glaxosmithkline Collegeville PA

Clinical Operations Head Oncology

Pfizer