Medical Director - Oncology Clinical Development - Cancer Epigenetics
Would you like to be an integral member of the Clinical Team within GSK's Cancer Epigenetics (CE) Research Unit ? If so, this could be an excellent opportunity to explore the following position.
The CE-RU focuses on the pre-clinical- and early clinical development of novel, preferentially first-in-class drug-candidates that target epigenetic molecular mechanisms dysregulated in cancer cells. The Medical Director will be responsible for all aspects related to the clinical development of either a single or multiple assets in the CE-RU.
In this role, the Medical Director will belong to multi-functional drug development team(s) and will work closely with scientists in the discovery- and translational-medicine groups within the CE-RU.
The Medical Director will be 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) and may decide to accompany the program to regulatory filing and registration. The Medical Director will contribute scientific and medical expertise to the activities of the Clinical Team and the RU.
- 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, case report form design
- 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 serious adverse event (SAE) reports from ongoing clinical studies and work in close collaboration with the CRO 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:
- Board certification/eligibility and clinical experience in a related medical specialty
- At least 5 years pharmaceutical or relevant scientific/medical/clinical experience in oncology/related field
- Experience or interest in experimental cancer-epigenetics is an advantage
- Early clinical trial (Phase 1 and 2) experience in pharmaceutical or biotech industries, or equivalent academic and clinical Oncology experience 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
If you have the following characteristics, it would be a plus:
- Board certification/eligibility and clinical experience in oncology or hematology/oncology preferred
- Familiarity with the key medical/scientific experts within the therapeutic field, with the capability of effectively interacting and/or collaborating with the experts
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
About GSK Oncology
GSK Oncology is committed to the discovery and development of new and potentially life-changing therapies for patients with cancer. Our vision is for people with cancer to not only to live, but to live well, because we are delivering innovative and transformational medicines. We have strictly focused our portfolio on innovation with a focus on the leading edges of science: immuno-oncology, cell therapy and epigenetics. Our deep insight into cancer biology coupled with strategic partnerships will allow us to develop synergistic combinations with transformational potential.
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