Senior Medical Director

Found in: Talent US C2 - 1 week ago

Boston, United States AstraZeneca Full time

Location

US: Boston or Gaithersburg, MD

Spain: Barcelona

Sweden: Gothenburg

Are you an experienced drug developer with expertise in immunology, rheumatology or inflammatory bowel disease? Would you like to be a part of a talented and high performing team of clinical research professionals, clinical scientists and physicians who are translating scientific discoveries into early phase clinical development plans and clinical studies across a wide range of diseases?

This role will be located at one of our Global Research and Development strategic sites, in the US, Spain or Sweden.

At AstraZeneca, we’re dedicated to being a Great Place to Work with an inclusive and diverse team who work in a solution-oriented, trusting, and collaborative work environment. We are dedicated to improving the health care and quality of life for patients across a wide range of diseases and disorders by developing innovative therapies that address unmet clinical needs and provide clinicians with novel evidence-based treatment options to optimize the care of their patients.

Who We Are

In the Respiratory and Immunology Early Clinical Development team, we are investigating the drivers of key respiratory and immunology diseases, with access to cutting edge science, innovative drug discovery approaches and key collaborations with academic centers around the world. We are investigating a wide range of different drug modalities – small molecules, biologics, oligonucleotides and cell therapies – across multiple diseases with high unmet medical need.

Early Clinical Development, part of the Early R&I organization, is where science meets clinical drug development with a focus upon delivering innovative, early phase clinical studies (Phase 1 – Phase 2b), while collaborating closely with our late phase clinical development colleagues who guide our phase 3 clinical studies. We are a diverse team of experienced physicians and clinical scientists who collaborate with scientists and translational medicine colleagues to define our early phase clinical development strategies, design innovative phase 1-2b clinical trials, develop and validate new clinical endpoints and translate scientific ideas to proof-of-concept studies in targeted patient populations.

We are recruiting for a Senior Medical Director (physician) and/or Senior Director (clinical scientists). In this role, you will have the opportunity to work at the forefront of early clinical and translational research within immunology at AZ. In a multidisciplinary environment, you will play a key role in progressing a rich and diverse pipeline in numerous active clinical programs.

What You Will Do

You will be responsible for managing and contributing to early phase I-IIb global clinical trials and related clinical research projects for compounds that are targeting immunology indications ranging from SLE and RA to IBD, as well as serving as an expert on the design, conduct, monitoring, data interpretation, and reporting of these studies. Additionally, you will work on cross-functional teams within our ECD group and across the broader early R&I organization that are framing our strategies and development plans for compounds that are a range of indications, including asthma, COPD and additional immunology indications.

You will take responsibility for clinical development in cross-functional teams to support early phase clinical development activities. These activities include the creation of overall clinical development plans and clinical study design as well writing protocols, key study and health authority documentation, medical monitoring and ensuring timely delivery of studies, all in close collaboration with relevant internal and external partners and clinical research organizations.

Responsibilities

Responsible for the design, delivery and interpretation of clinical studies from first-in human through Ph2b, ensuring compliance with GCP and ethical / scientific integrity of studies Lead ongoing monitoring of clinical data to ensure quality and safety, including SAE/SUSAR/protocol deviations and periodic review of emerging safety data by SRC/DMCs, and oversee the support of investigational sites on protocol related matters and investigation of unexpected trends in data Lead clinical development strategy from early target identification through Phase 2b (with senior support as necessary) and secure cross-functional alignment across wider AZ organization Provide clinical development /disease expertise to Research, Translational Medicine, Early and Late-stage Clinical Development and Commercial colleagues as part of a cross functional teams Closely follow medical developments within the autoimmune / inflammatory diseases and disseminate new information within Clinical Development and the wider organization to transform trends and emerging data into agile and innovative clinical plans. Represent Early R&I Clinical Development at internal governance interactions and with external stakeholders, including Investigators, key external experts and patient advocacy groups (eg regulatory, site, CROs and KEEs) Medical lead for regulatory communication and preparation of higher-level study documents (protocols, briefing books, ICFs, PIPs, SAPs) Support qualification of pharmacodynamic/disease markers for early assessment of efficacy. As available, provide clinical strategic input to in-licensing opportunities.

Who You Are

We believe you are a medical doctor with relevant specialty clinical training or scientist with an advanced scientific degree (PhD or Pharm D) and training relevant for the role. We believe you will have had a minimum of 7-10 years of clinical research experience, including significant experience in early phase drug development in non-oncology diseases within the biopharmaceutical/biotechnology industry. You will thrive in a fast-paced, proactive can-do culture, be a highly effective internal and external team player, as well as a strong communicator and collaborator.

Required Education Skills and Experience

Advanced degree in relevant scientific discipline (MD, PhD, PharmD), with relevance for immunology / rheumatology a plus. Subject matter expertise in rheumatology, immunology and /or inflammatory bowel disease via training and/or experience strongly preferred. Must have significant experience (more than 9 years experience) in early phase clinical development, including hands-on experience in the design, delivery and interpretation of multiple Ph1 / Ph2 studies in relevant non-oncology indications Significant experience in the authoring or relevant regulatory documents, including INDs, protocols, ICFs, PIPs, briefing books as well authoring responses to HAs / ECs and site queries Thorough understanding of the entire drug development process, including clinical and non-clinical study design and execution, and a thorough understanding of clinical research methodology and biostatistics principles, to facilitate innovative and efficient clinical trial design, and clinical development plans with clear data-driven decision rules. Thorough command of FDA, MHRA and ICH GCP guidelines to ensure the appropriate conduct of global clinical studies in the United States, Europe and rest of world. Attention to detail, internal drive to generate high-quality work, and sense of passion and urgency to achieve team and program goals. Demonstrated experience managing complex projects and working collaboratively with multiple stakeholders regarding new strategies to ensure consistent communication. Demonstrated track record in delivering results. Outstanding verbal and written communication skills. Excellent analytical, problem solving and strategic planning skills. Ability to thrive in a fast-paced environment.

Why AstraZeneca?

Here, we need leadership at every level - leaders who not only have expertise, but also the ability to build a case, engage multiple partners, and communicate effectively with different audiences. Early clinical development is at the forefront of discovery of new medicines for patients with high unmet need. With that kind of remit comes great responsibility. Your curiosity and passion for personal development combined with support from colleagues, mentors and leaders, will ensure you maximize your skills, abilities and contribution. We offer a competitive salary and excellent benefits.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give 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 culture.

So, what’s next?

Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you. Welcome to apply

Where can I find out more?

AstraZeneca Boston:

R&I at AstraZeneca:


This is what we’re made of: ;t=2s
 

Date Posted

12-Apr-2024

Closing Date

10-May-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

  • Director/Senior Director

    Found in: Jooble US O C2 - 2 weeks ago

    Boston, MA, United States Only Medics Full time

    Senior Director Clinical Development Job Type: Permanent Senior Director Clinical Development Neurology (MDD) Location: US, Fully Remote The organization have an extremely advanced and healthy portfolio with multiple assets across phases I-III and are seeking a Senior Director Clinical Development. This novel product pipeline of neurology-focused...

  • Senior Medical Director, Global Drug Safety

    5 days ago

    Boston, United States AstraZeneca Full time

    This is what you will do:The Senior Medical Director provides global strategic and operational oversight of Alexions Safety Surveillance and Risk Management activities for assigned therapeutic area in fulfillment of global legislation and regulations. The jobholder defines the Safety Surveillance and Risk Management strategy and ensures its execution through...

  • Senior Medical Director, Global Drug Safety

    10 hours ago

    Boston, United States Alexion Pharmaceuticals, Inc. Full time

    This is what you will do: The Senior Medical Director provides global strategic and operational oversight of Alexion's Safety Surveillance and Risk Management activities for assigned therapeutic area in fulfillment of global legislation and regulations. The jobholder defines the Safety Surveillance and Risk Management strategy and ensures its execution...

  • Senior Medical Director, Global Drug Safety

    8 hours ago

    Boston, United States Alexion Pharmaceuticals, Inc. Full time

    This is what you will do: The Senior Medical Director provides global strategic and operational oversight of Alexion's Safety Surveillance and Risk Management activities for assigned therapeutic area in fulfillment of global legislation and regulations. The jobholder defines the Safety Surveillance and Risk Management strategy and ensures its execution...

  • Director of Psychiatry- Medical Director

    Found in: Jooble US O C2 - 2 weeks ago

    Boston, MA, United States Boston Medical Center Full time

    Medical Director of Addiction Psychiatry Treatment Program (APTP) Boston University School of Medicine, Department of Psychiatry As an academic institution at Boston Medical Center, active engagement in research and education is encouraged with new resources available for program development and scholarly pursuits. Education/supervision opportunities are...

  • Medical Director, GDS

    9 hours ago

    Boston, United States Alexion Pharmaceuticals, Inc. Full time

    This is what you will do: The Medical Director, Global Patient Safety (GPS) is accountable for executing the safety and risk management activities for one or more assigned clinical development projects or marketed products to enable the safe and effective use of Alexion's products by patients and healthcare providers. The Medical Director will be...

  • Director/Senior Director, Clinical Pharmacology

    8 hours ago

    Boston, United States Third Rock Ventures Full time

    As our clinical development portfolio evolves, Tango has an exciting new opportunity to join our team as a Director/Senior Director, Clinical Pharmacology. Reporting to our SVP, Pharmaceutical Sciences, you will be responsible for the design and implementation of clinical pharmacology aspects of patient trials and NDA-enabling clinical pharmacology studies....

  • Director/Senior Director, Clinical Pharmacology

    11 hours ago

    Boston, United States Tango Therapeutics Full time

    Company Overview Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer. Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at...

  • Senior Director, Regulatory Affairs

    Found in: beBee jobs US - 1 day ago

    Boston, Massachusetts, United States Proclinical Full time

    Senior Director, Regulatory Affairs - Permanent - RemoteProclinical Staffing is seeking a Senior Director, Regulatory Affairs to join a leading health information technology and clinical research organization. This is a permanent role with the opportunity to work remotely.Primary ResponsibilitiesIn this role, you will provide leadership and advice on the...

  • Senior Project Director

    Found in: Jooble US O C2 - 1 week ago

    Boston, MA, United States Hebrew Senior Life Full time

    Overview The Marcus Institute for Aging Research seeks a Senior Project Director to work in the Brain Stimulation and Home-Based Neuromodulation Program run by Dr. Alvaro Pascual-Leone and Dr. Bradley Manor. The mission of the program is to provide effective brain stimulation treatments to individuals with dementia within their home, to train clinicians in...

  • Senior Director of Quantitative Data Analytics

    6 days ago

    Boston, United States Five Star Senior Living Full time

    Key Responsibilities The Opportunity The Senior Director of Quantitative Data Analyticsreports directly to the office of the CEO. This is a key strategic role responsible for leveraging data to drive business insights that will drive the growth and transformation of our business. This role is a data expert, responsible for mining data from multiple...

  • Director/Senior Director, Quality Management

    Found in: Jooble US O C2 - 2 weeks ago

    Boston, MA, United States The National Council of Young Men’s Christian Associations of the United States of America Full time

    Senior Aquatics Director, Burbank YMCA, Reading Massachusetts Under the direction of the Executive Director, the Senior Aquatics Director is responsible on a daily basis for creating a transformative Y Experience for our program participants, families, members and staff. The Senior Aquatics Director must be able to lead and manage people to execute an...

  • Senior Medical Director, Drug Safety

    5 days ago

    Boston, United States Klein Hersh Full time

    Reporting to the Head of Global PV & Risk Management, the Senior Medical Director will be responsible for assessing and interpreting safety data from multiple sources, including clinical trials, spontaneous and solicited reports, aggregate, and literature reports. This physician is expected to provide interpretation and summaries of drug safety information...

  • Senior Medical Director, Drug Safety

    7 days ago

    Boston, United States Klein Hersh Full time

    Reporting to the Head of Global PV & Risk Management, the Senior Medical Director will be responsible for assessing and interpreting safety data from multiple sources, including clinical trials, spontaneous and solicited reports, aggregate, and literature reports. This physician is expected to provide interpretation and summaries of drug safety information...

  • Senior Director of Marketing

    2 weeks ago

    Boston, United States Spencer Rigby Full time

    This Senior Director of Marketing opportunity presents a unique opportunity to transform the marketing strategy for a market leading Electro Mechanical Medical Device portfolio. Currently very upstream orientated, we are seeking a marketing leader that will bring a proactive commercial edge to strategy.Leading a $600m portfolio with 10+ team members, you...

  • Senior Director of Marketing

    Found in: Appcast Linkedin GBL C2 - 2 weeks ago

    Boston, United States Spencer Rigby Full time

    This Senior Director of Marketing opportunity presents a unique opportunity to transform the marketing strategy for a market leading Electro Mechanical Medical Device portfolio. Currently very upstream orientated, we are seeking a marketing leader that will bring a proactive commercial edge to strategy.Leading a $600m portfolio with 10+ team members, you...

  • Administrative Director for Accreditation and Strategy

    1 week ago

    Boston, United States Boston Medical Center Full time

    POSITION SUMMARY:The Administrative Director for Accreditation and Strategy provides administrative and strategic oversight and direction for all accreditation activities and efforts that fall under the Office of Graduate Medical Education (GME). These activities include the supervision of operations, development and execution of strategic initiatives...

  • Sr. Medical Director, MassHealth

    11 hours ago

    Boston, United States University of Massachusetts Medical School Full time

    Overview Under the general direction of the Director of the Office of Clinical Affairs (OCA)/Chief Medical Officer or designee, the Sr. Medical Director MassHealth:• Supports the designated MassHealth programs such as Payment and Care Delivery Innovation.• Develops, implement and support program and policies to improve clinical performance through...

  • SENIOR MEDICAL DIRECTOR, GLOBAL DRUG SAFETY

    Found in: Careerbuilder One Red US C2 - 1 day ago

    Boston, MA 02298, USA, United States Alexion Pharmaceuticals, Inc. Full time

    This is what you will do:The Senior Medical Director provides global strategic and operational oversight of Alexion's Safety Surveillance and Risk Management activities for assigned therapeutic area in fulfillment of global legislation and regulations. The jobholder defines the Safety Surveillance and Risk Management strategy and ensures its execution...

  • Senior HNW Tax Director

    1 week ago

    Boston, United States CareerBuilder Full time

    Senior HNW Tax Director About the Company Market leader in the wealth management space Industry Investment Management Type Privately Held About the Role The Senior HNW Tax Director will be responsible for providing dynamic leadership to steer the tax department toward improved operational efficiency and numerical accuracy that aligns with critical business...