Director Study Leader, Hbs Specialist, Oncology

2 weeks ago

Waltham, United States AstraZeneca Full time

**Introduction to role**:
Join us in our mission to eliminate cancer as a cause of death. As the Director Study Leader Human Biological Sample (HBS) Specialist in Early Oncology Clinical (EOC), you will be responsible for delivering complex studies and managing best practices across EOC for HBS. This role requires a high degree of flexibility and autonomy, with potential opportunities for program level responsibilities. You may also provide expert input to other non-drug programs and improvement projects.

**Accountabilities**:
As a Director Study Leader, you will provide expert clinical operational input into project or study level documents, lead the delivery of clinical studies from concept to final CSR, and ensure timely delivery to quality, budget and time. You will also be responsible for planning and leading issue escalation and resolution, forecasting and management of study delivery costs, resource and timelines, and oversight of CROs and other clinically outsourced third party vendors for outsourced studies. Expert in RTSM acting as a tactical and strategic partner to both study teams and GCS

**Crucial Skills/Experience**:

- Bachelor’s degree in related discipline, preferably in medical or biological science.
- At least 10 years drug development experience demonstrated in a variety of roles.
- At least 5 years of experience in leading studies in clinical development.
- Extensive knowledge of the clinical and pharmaceutical drug development process.
- Extensive and proven experience in driving operational delivery to timelines, cost and quality.
- Proven experience leading delivery through internal and external organizations.
- Project Management experience within the context of Clinical Drug Development.
- Experience and strength in working and leading in matrix teams.
- Strong collaborative communications skills including the ability to engage with a diverse client base and manage through conflict.
- Proven track record in problem solving and issues management that is solution focused.

**Desirable Skills/Experience**:

- Higher degree e.g. PhD, MSc, MPhil.
- Programme management qualification (e.g. MBA, PRINCE2).
- Experience in variety of academic/CRO/Sponsor organisations and countries.
- Early oncology clinical delivery.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn't mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

**Why AstraZeneca?**
At AstraZeneca's Oncology R&D, we push the boundaries of science to change the practice of medicine and transform the lives of patients living with cancer. With one of the broadest and deepest Oncology pipelines in the industry, there are many opportunities to work with new and novel drugs and help discover what's next. We foster a mindset of courage, where everyone is empowered to step up, innovate and work at pace. We lead through true collaboration, building collective wisdom by giving everyone a chance to input. It's science with an impact-making a difference for patients and people around the world.

Take a crucial inter-disciplinary approach to save patients' lives Work at the forefront by taking an inter-disciplinary approach including novel biomarkers, AI, novel endpoints and cutting-edge trial designs. It's because we are constantly innovating that we are able to develop life-changing medicines, change the way cancer is treated and ultimately improve outcomes for patients everywhere.

  • Senior Medical Director

    Found in: Jooble US O C2 - 1 week ago

    Waltham, MA, United States AstraZeneca GmbH Full time

    AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. We are more than one of the world’s leading pharmaceutical companies. AstraZeneca has a multifaceted environment that cultivates...

  • Senior Director Clinical Programs

    1 week ago

    Waltham, United States Zenith LifeScience Full time

    Provides expert clinical operational input into project or study level documents, for example clinical development plan, clinical study protocol, clinical study report, and may lead the delivery of study documentsWith oversight from the Senior Director Clinical Programs, may lead and deliver differentiated and robust operational options for review at...

  • Senior Director Clinical Programs

    Found in: Appcast US C2 - 1 week ago

    Waltham, United States Zenith LifeScience Full time

    Provides expert clinical operational input into project or study level documents, for example clinical development plan, clinical study protocol, clinical study report, and may lead the delivery of study documentsWith oversight from the Senior Director Clinical Programs, may lead and deliver differentiated and robust operational options for review at...

  • Senior Director Clinical Programs

    Found in: Appcast Linkedin GBL C2 - 2 weeks ago

    Waltham, United States Zenith LifeScience Full time

    Provides expert clinical operational input into project or study level documents, for example clinical development plan, clinical study protocol, clinical study report, and may lead the delivery of study documentsWith oversight from the Senior Director Clinical Programs, may lead and deliver differentiated and robust operational options for review at...

  • Executive Director, Global Project Leader

    Found in: Jooble US O C2 - 7 days ago

    Waltham, MA, United States Workday Full time

    At AstraZeneca, we are committed to advancing the science of oncology to deliver life-changing medicines to patients most in need. With a combination-focused pipeline that exploits the power of six scientific platforms (Immuno-Oncology, Tumor Drivers and Resistance, DNA Damage Response, Antibody-drug Conjugates, Cell Therapy, and Epigenetics) to help...

  • Associate Director Biostatistics

    Found in: Appcast US C2 - 1 week ago

    Waltham, United States RBW Consulting Full time

    RBW Consulting has partnered with a very exciting small biotech company in Greater Boston in part of their search for an Associate Director of Biostatistics. This role will be hybrid in the Greater Boston area, with a very close-knit team and strong leadership.You will be leading and implementing statistical analyses to support early development clinical...

  • Associate Director Biostatistics

    Found in: Appcast Linkedin GBL C2 - 2 weeks ago

    Waltham, United States RBW Consulting Full time

    RBW Consulting has partnered with a very exciting small biotech company in Greater Boston in part of their search for an Associate Director of Biostatistics. This role will be hybrid in the Greater Boston area, with a very close-knit team and strong leadership.You will be leading and implementing statistical analyses to support early development clinical...

  • Executive Director Global Product Lead, Oncology R&D

    Found in: Talent US C2 - 2 weeks ago

    Waltham, United States AstraZeneca Full time

    Description Our Gaithersburg, Maryland facility builds life-changing medicines for people around the world. The modern, vibrant scientific campus employs more than 3000 experts in our field, and it is only a short drive from Washington, DC. It is filled with pioneering technology. Our work areas were built to facilitate collaboration, interaction...

  • Associate Director, Medicinal Chemistry, TTD, Early Oncology

    Found in: beBee S US - 1 week ago

    Waltham, United States AstraZeneca Full time

    Associate Director, Medicinal Chemistry, TTD, Early OncologyThis role is part of our strategy to deliver next generation of therapeutics including, but not limited to, small molecule, peptide and antibody drug conjugates to treat cancer.Close collaboration with computational chemistry, in vivo pharmacology, structure biology, and related functions will be...

  • Director, Biostatistics

    Found in: Resume Library US A2 - 1 week ago

    Waltham, Massachusetts, United States Deciphera Pharmaceuticals Full time

    Job Description We are seeking a Director of Biostatistics to join our team. In this role, the successful candidate will serve as the lead study statistician on one or more drug programs, which may include complex and/or pivotal studies. The successful candidate may also lead regulatory submission related tasks and represent Deciphera in communications with...

  • Change Management Specialist

    Found in: Appcast Linkedin GBL C2 - 5 days ago

    Waltham, United States Fladger Associates Full time

    Responsibilities:Excellent employment opportunity for a Change Manager Associate Director in the Waltham, MA and at Seaport, Boston area.Waltham is a well-established R&D site, delivering both Oncology & BioPharm discovery science. Develops and executes change management strategy and plan and activities in line with Company Global requirements and...

  • Associate Director, Medicinal Chemistry, TTD, Early Oncology

    Found in: beBee jobs US - 2 weeks ago

    Waltham, Massachusetts, United States AstraZeneca Full time

    Associate Director, Medicinal Chemistry, TTD, Early OncologyThis role is part of our strategy to deliver next generation of therapeutics including, but not limited to, small molecule, peptide and antibody drug conjugates to treat cancer.Close collaboration with computational chemistry, in vivo pharmacology, structure biology, and related functions will be...

  • Associate Director Change Management

    Found in: Appcast US C2 - 5 days ago

    Waltham, United States AstraZeneca Full time

    Responsibilities: Excellent employment opportunity for a Change Manager Associate Director in the Waltham, MA and at Seaport, Boston area.Waltham is a well-established R&D site, delivering both Oncology & BioPharm discovery science. Develops and executes change management strategy and plan and activities in line with Company Global requirements and...

  • Director, CMC Regulatory Affairs

    Found in: beBee jobs US - 2 weeks ago

    Waltham, Massachusetts, United States Tscanrx Full time

    We are looking for an experienced CMC professional to join our team as a Director of CMC Regulatory Affairs supporting our growing pipeline of TCR T-cell therapies.The Director of CMC Regulatory Affairs will be responsible for supporting and leading the development and implementation of US, eventually global, CMC regulatory strategies for TScan's oncology...

  • Director, CMC Regulatory Affairs

    Found in: beBee S US - 1 week ago

    Waltham, United States Tscanrx Full time

    We are looking for an experienced CMC professional to join our team as a Director of CMC Regulatory Affairs supporting our growing pipeline of TCR T-cell therapies.The Director of CMC Regulatory Affairs will be responsible for supporting and leading the development and implementation of US, eventually global, CMC regulatory strategies for TScan’s oncology...

  • Associate Director

    Found in: Jooble US O C2 - 2 weeks ago

    Waltham, MA, United States AstraZeneca GmbH Full time

    Associate Director – Oncology Safety Pathology, Clinical Pharmacology and Safety Sciences Are you a passionate veterinary anatomic pathologist interested in driving innovation in drug discovery to bring safe and effective therapies to cancer patients? This is an exciting opportunity to join a global group of highly skilled pathologists that work...

  • Executive Director, Medical Director

    Found in: beBee S US - 1 week ago

    Waltham, United States Dyne Therapeutics Full time

    Company Overview: Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle...

  • Executive Director/Director, Partnerships

    Found in: Jooble US O C2 - 2 weeks ago

    Waltham, MA, United States AstraZeneca PLC Full time

    Hematology is central to our strategy and vision for AstraZeneca's becoming the leading company in the discovery and development of innovative medicines for cancer patients. We have built an end-to-end Hematology R&D team within Oncology R&D that demonstrates our technology platforms and deep mechanistic scientific activities. The coordinated structure...

  • Associate Director

    Found in: Jooble US O C2 - 2 weeks ago

    Waltham, MA, United States AstraZeneca PLC Full time

    Associate Director - Oncology Safety Pathology, Clinical Pharmacology and Safety Sciences Are you a passionate veterinary anatomic pathologist interested in driving innovation in drug discovery to bring safe and effective therapies to cancer patients? This is an exciting opportunity to join a global group of highly skilled pathologists that work closely...

  • Executive Director, Medical Director

    Found in: beBee jobs US - 2 weeks ago

    Waltham, Massachusetts, United States Dyne Therapeutics Full time

    Company Overview:Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue....