Physician Project Leader- Oncology Clinical Development -BET inhibitor – Collegeville, PA 19426

Site Name: USA – Pennsylvania – Upper Providence
Posted Date: Nov 14 2019

At GSK we are proud to highlight a diverse and growing portfolio of potentially transformational medicines for cancer patients. If you are keen to be responsible for leading the clinical development strategy for a clinical stage epigenetics program, then this Physician Project Leader opportunity could be an excellent opportunity to explore.

The Physician Project Leader (PPL) will be an integral part of the Clinical Team within the GSK Cancer Epigenetics platform responsible for leading the clinical development strategy for a clinical stage epigenetics program.

In this role, the PPL will belong to multi-functional drug development team(s) and will work closely with scientists, statisticians, and other physicians in the discovery- and translational-medicine groups.

The Physician Project Leader will be reporting within and managing clinical development team(s) consisting of physicians, and clinical scientists. The candidate will provide critical clinical guidance from the selection of a drug candidate to the initial proof-of-concept in clinical trial(s) passing through phase I, II, and pivotal phase IIII including regulatory filing and registration. The PPL will contribute scientific and medical expertise as well as strategic leadership and experience in clinical trial design insights to the activities of the Clinical Team.

https://us.gsk.com/en-us/careers/a-career-in-oncology/

The Physician Project Leader (PPL) will be an integral part of the Clinical Team within the GSK Cancer Epigenetics platform responsible for leading the clinical development strategy for a clinical stage epigenetics program.

In this role, the PPL will belong to multi-functional drug development team(s) and will work closely with scientists, statisticians, and other physicians in the discovery- and translational-medicine groups.

The Physician Project Leader will be reporting within and managing clinical development team(s) consisting of physicians, and clinical scientists. The candidate will provide critical clinical guidance from the selection of a drug candidate to the initial proof-of-concept in clinical trial(s) passing through phase I, II, and pivotal phase IIII including regulatory filing and registration. The PPL will contribute scientific and medical expertise as well as strategic leadership and experience in clinical trial design insights to the activities of the Clinical Team.


Key elements of the role

  • To provide Clinical Leadership, Disease Area Expertise, and Prescriber Insight for an asset in development
  • To support Medical Governance for an asset in development or a marketed product with specific accountability for governance of clinical research and a global viewpoint of safety and efficacy throughout the entire lifecycle of a medicine, working the accountable Pharmacovigilance and safety teams
  • To provide single point of accountability for the end to end Clinical Development Plan for as asset in development.
  • To act as Data Steward of the clinical data for an asset in development or a marketed product
  • To work in partnership for all of the above with the Safety Development Leader (SDL) and the Global Medical Affairs Leader (GML), accountable to the MDL for an asset in development or the Therapeutic Area portfolio owner or a marketed product


Responsibilities:

  • Strategic leadership for clinical development plans
  • Management of critical resources and clinical project timelines
  • Preparation, design, and/or review of clinical documents, e.g. protocols, investigator’s brochures, electronic case report form (e-CRF) design
  • Immuno-oncology Clinical trial design and optimization
  • Data optimization and oversight of eCRF creation, optimization, and finalization.
  • Participation in interpretation of data analyses of clinical trial results and developing clinical trial reports
  • Lead preparation of clinical sections of relevant regulatory filings (IND, study reports, NDA, etc.)
  • Serve as the Medical Monitor for clinical trials, to address patient eligibility and treatment questions in cooperation with the contract research organization (CRO) or directly with study investigators
  • Participation in site/investigator identification and evaluation for clinical trials; conduct site initiation and engagement calls and visits
  • Review safety data for routine medical data review, trend review, and safety signals from ongoing trials
  • Review adverse event (AE)/ serious adverse event (SAE) reports from ongoing clinical studies and work in close collaboration with GSK safety /the CRO safety team to review causality and develop MedWatch/CIOMS reports (including narratives and analyses of similar events) for reportable SAEs
  • Serve as program medical expert for internal and external collaborators, investigators, consultants, and contract resources
  • Represent GSK-Oncology at scientific meetings and presentations
  • Contribute to scientific affairs by authoring and / or reviewing abstracts, presentations and manuscripts for medical accuracy and content
  • Lead and provide medical support for investigator and consultant meetings (e.g., investigator meetings, clinical advisory boards)
  • Develop and manage relationships with key opinion leaders for clinical programs
  • M.D. or M.D./Ph.D.
  • Board certification/eligibility, and clinical experience in oncology or hematology/oncology preferred
  • At least 5 years pharmaceutical or relevant scientific/medical/clinical experience
  • Experience or interest in experimental cancer-therapeutics especially with epigenetic agents is advantageous
  • Early clinical trial (Phase 1 and 2) or late (phase 3) experience in pharmaceutical or biotech industries, or equivalent academic and clinical Oncology experience especially immune-oncology preferred
  • Understanding and track record in trial design, conduct, and medical monitoring preferred
  • Ability to work proactively and effectively applying creative problem-solving skills
  • Excellent strategic planning, organizational and communication skills
  • Managerial experience working within or leading high-performance, cross-functional matrix teams


Behavioral Attributes:

  • Leadership (expertise, self-awareness, high performance behaviors and ability to execute the assigned role(s)) in a matrix and line environment
  • Acting as a coach and/or mentor to one another and other members of the team, especially junior physicians in the matrix and therapy area
  • Driving a disciplined approach to clinical research by ensuring a relentless focus on quality, compliance, scientific rigor and operational excellence
  • Embedding a culture of individual empowerment across the broader study team
  • Leading by example and modelling the GSK Behaviors:

    • Flexible Thinking
    • Continuous Improvement
    • Customer Driven
    • Developing People
    • Enable & Drive Change
    • Building Relationships

Board certification/eligibility, and clinical experience in oncology or hematology/oncology preferred

Experience in Cancer Epigenetics


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, governance and control, managing ambiguity and paradox.
  • Managing individual performance.
  • Creating a performance culture and driving results, prioritisation, execution, delivering performance.
  • Setting strategic direction and leading on-going organisational transformation.
  • Building a resilient organisation. Building strong relationships and collaboration in service of common goals, engaging the organisation and building trusted external networks for mutual benefit.
  • Managing P&L and capital allocation.

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/Affirmative Action Employer. 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.

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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.

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