- Provide leadership to the overall pipeline and portfolio. This includes continual ownership of R&D, optimization of the organizational design and resources, ownership of and optimization of key processes, and talent and succession management.
- Develop clinical development plans, trial designs, clinical trial execution, and medical governance.
- Responsibility for overall pipeline and portfolio delivery in Ocular Oncology, working with Preclinical, Regulatory Affairs, Quality, Clinical Operations, and other relevant departments and functions.
- Serve as Medical Lead for assigned clinical trials/programs and ensure support of operational trial execution for Clinical Operations, Regulatory Affairs, Devices, Data Management, Statistics, and other clinical trial team functions.
- Define disease area strategies in R&D and potential partnership priorities.
- Accountable for ethical conduct of studies in the Ocular Oncology TA.
- Operate as a single point of contact for medical governance at the Ocular Oncology level.
- Be responsible for preparation of clinical sections of regulatory documents (INDs, IND annual reports, briefing packages, etc.), and collaboratively prepare for meetings with the FDA/EMA.
- Stay current with GCP and regulatory requirements in the preparation and review of the clinical submission in the US and EU.
- Interface with preclinical research and development leadership in the evaluation and analysis of product opportunities.
- Responsible for championing clinical excellence across the portfolio.
- Manage and maintain strong effective relationships with external stakeholders and partners, KOLs, investigators, consultants, patient advocacy groups, and external clinical trial participants to show the primary goals of clinical development.
- Lead a team of empowered and motivated clinical staff; drive the vision and align the team to achieve success in developing assets in the TA.
- Support investigator meetings and participate in site visits with clinical trial investigators when needed.
- Explore opportunities for simplification, ensuring that the TA is as effective and efficient as possible.
- MD, PhD or PharmD with experience in oncology
- 10 years of clinical development experience with depth in late stage.
- Proven line management skills, with at least 5 years of managing teams directly or indirectly.
- Proven ability to strategize, prioritize, and manage multiple projects simultaneously to ensure quality, timeliness, on target, and within budget of accomplished tasks.
- Attention to detail while discriminating between critical and non-critical activities and ability to follow established processes when identifying areas of process improvement.
- Strong leadership and interpersonal skills; high emotional intelligence to enable favorable group dynamics and the ability to influence others at all levels.
- A self-motivated entrepreneurial spirit, with a roll-up-sleeves mentality and a problem-solving, can-do attitude.
- Highly developed ethics and integrity, with demonstrated ethical medical decision-making skills
- Excellent organizational, time management, and written and verbal communication skills.
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Vice President, Clinical Development - Boston, United States - Aura Biosciences Inc.
3 weeks ago
Description
ABOUT AURA:
At Aura, our mission is to develop a new class of oncology targeted therapies that deliver meaningful therapeutic benefit to a range of cancer indications with high unmet need in which we believe we can establish a new standard of care.
We are driven by our passion and commitment to science and the patients battling cancer who are relying on us to pioneer these new therapies.
We are focusing the initial development of our VDC technology platform to treat tumors of high unmet need in ocular and urologic oncology.
AU-011, our first VDC candidate, is being developed for the first line treatment of primary choroidal melanoma, a rare disease with no drugs approved.
Beyond primary choroidal melanoma, we are developing AU-011 in additional ocular oncology indications, including choroidal metastases.Leveraging our VDCs' broad tumor targeting capabilities, we also plan to initiate a clinical program in non-muscle invasive bladder cancer, or NMIBC, our first non-ophthalmic solid tumor indication.
RESPONSIBILTIES:
Aura is seeking an experienced, collaborative, and strategic oncology executive to join the team as Vice President, Clinical Development.
Reporting to the Chief Medical Officer, the VP will help build strategy and realize a future-oriented vision for Aura's oncology portfolio.
This leadership role requires proven abilities to drive research and development, strategic innovation, and measurable business outcomes.The incumbent's track record of therapeutic expertise will be extensive and play a key role in the current and future business success of Aura Biosciences.
Key responsibilities include:
