Physician Project Lead- Early Immuno-Oncology Clinical Development
- Weston, MA
Site Name: USA - Massachusetts - Waltham, USA - Pennsylvania - Upper Providence
Posted Date: Nov 19 2020
Are you keen to join the excitement and energy of the Clinical Teams in a leadership role within the GSK Immuno-Oncology Research Unit at GSK? If so, thispositionmay be an ideal opportunity to explore.
GSK Oncology R&D is focused on building industry-leading portfolios in four cutting-edge areas of science:
•Immuno-Oncology : using the human immune system to treat cancer
• Cell/Gene Therapy: engineering human T-cells to target cancer
•Cancer Epigenetics: modulating the gene-regulatory system of the epigenome to exert anti-cancer effects
•Synthetic Lethality: targeting two mechanisms at the same time which together, but not alone, have substantial effects against cancer
The Physician Project Leader (PPL) will be an integral part of the Clinical Team within the GSK Immuno-Oncology (IO) Research Unit (RU). The IO-RU focuses on the pre-clinical, early, and late clinical development of novel, preferentially first-in-class transformational drug-candidates that affect the immune system to maximize tumor control and result in increased survival of patients. The Physician Project Leader will be responsible for all aspects related to the late-stage clinical development of an IO asset.
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(s) 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 or a marketed product
- 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
- 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 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
- Attend 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
We are looking for professionals with these required skills to achieve our goals:
- M.D with board certification/eligibility, and clinical experience in oncology or hematology/oncology
- At least 5 years pharmaceutical or relevant scientific/medical/clinical experience
- Experience or interest in experimental cancer-therapeutics especially immune-oncology is an 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 immuno-oncology
- Leadership (expertise, self-awareness, high performance behaviors and ability to execute the assigned role(s)) in a matrix and line environment
- Coaching and/or mentoring experienceto one another and other members of the team, especially junior physicians in the matrix and therapy are
- Demonstrated drive and discipline approach to clinical research by ensuring a relentless focus on quality, compliance, scientific rigor and operational excellent
- Ability to embedding a culture of individual empowerment across the broader study team
If you have the following characteristics, it would be a plus:
- Clinical Judgment Experience - Has demonstrated a proven track record of effectively applying medical expertise to make good clinical decisions, in accordance with appropriate SOP(s).
- Scientific Presentation - Demonstrates the ability to communicate effectively through formal presentation and through informal scientific discussion with credibility, accuracy, and confidence with internal and external stakeholders and experts.
- Business Acumen - Understands the implications of decisions related to human, financial, material and information resources, from a business perspective and uses this knowledge to plan, implement and manage clinical research within R&D.
- Strategic Thinking - Maintains competitive advantage by ensuring the application of the principles, tools and systems from Simplifying Clinical Development.
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:
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