Director/Senior Director Clinical Research - Hematology/Oncology Job Listing at AstraZeneca in Waltham, MA

Biotechnology, Science/Research

  Description: In Early Development in global oncology at AstraZeneca, the Clinical Research Physician has a pivotal role in designing, executing and interpreting clinical research programs enabling successful transitions from candidate drug selection to phase III clinical development. The physician/scientist provides medical and scientific expertise and tactical and strategic development input to the teams working on discovery and development of AZ compounds and evaluation of in-licensing opportunities.  
The research physician is accountable to the Medical Science Director (MSD) of the Clinical Product Team for provision of strategic development input to Innovative Medicine Teams for the clinical developability of molecules as well as designing, conducting, and interpreting and reporting the results of clinical trials primarily supported by the Waltham based Clinical Product Team, and with developing strategies for the treatment of hematologic malignancies with the hematology disease area team.  
The clinical research physician is responsible for ensuring that all clinical studies operate to the highest ethical and safety standards and in compliance with company, GCP and regulatory requirements. This will involve studies in patients, phase I healthy volunteers and method development and proof of concept studies in both patients and volunteers. The individuals may be required to lead the clinical development of a molecule within a broader Emerging Product Team. The individual can expect to get broad international exposure to other functions involved in the RD process within AZ, get an overview of how strategic direction is set within the Clinical and other functions and how decisions are made during drug development. The position is based in Waltham, MA.     PRINCIPAL RESPONSIBILITIES: The general responsibilities for a Clinical Research Physician will include accountabilities for emerging product clinical studies, clinical strategies for IMED teams and for the hematology disease area team, including:
* Provide Medical/Scientific guidance to Clinical Product and disease area teams for candidate drugs. Contribute to Target Product Profiles (TPP) and claims (TPC), and hematology disease area
* Contribute to the Clinical Development Plan as requested by the medical science director (MSD )
* Assist the MSD in assessment of the overall benefit/risk of the product
* Prepare medical components of higher level documents (e.g. target product profile, target product claim, investigational new drug application, clinical study protocols and reports and other regulatory communications) under the direction of the MSD, as required.
* Provide medical assistance and leadership to investigator meetings
* Follow important developments and relevant trends in the scientific literature and develop/maintain contacts with external experts to support understanding of the candidate drug effects and to gain strategic insights into the further development and placement of study and the overall program
* Where appropriate, develop effective relationships with external providers to ensure successful medical oversight of outsourced studies
* Assume other responsibilities under the direction of the MSD, Clinical Program Director and Therapeutic Area Clinical VP
* For projects still in the IMED discovery phase with hematologic indications, the research physician will be responsible for;   1) the quality of the clinical / development contribution at target selection, with refinement at Lead Generation (when chemistry is feasible) and further refinement of the clinical plan as part of the team's Lead Optimization investment decision documents and presentations   2) working with the team biologist and translational strategist and personalized health care experts to define strategies for personalized health care, incorporation of biomarkers to support proof of mechanism and proof of principal trials   3) identifying combinations with established and novel agents   4) ensuring effective bidirectional communication with appropriate discovery and development teams globally both within AstraZeneca and its affiliates and with external investigators, including regional (currently US and UK) and global teams   5) provide strategies and identify and support opportunities for early external collaboration. Partner with MSD to coach, mentor, retain, motivate and inspire individuals in the clinical research group
* Identify opportunities for external collaboration to optimize translational and clinical strategies
* Provide the initial clinical strategies for development for launch as appropriate at target selection to identify critical study design and execution challenges
* Provide initial clinical development input to the IMPD (investigational medicines product document)
* Evaluate relevant molecular models against the targets and provide an assessment of the value of the models in the development investment decisions.
* Identify the strength of clinical/commercial drivers to support technically challenging targets
* Develop clinical evidence for functional relevance of targets in human disease
* Support qualification of pharmacodynamic/disease markers for early assessment of efficacy
* Ensure that clinical input into the DTDs, Translational Medicine and development strategies and plans receive adequate peer consultation to assure high scientific quality
* Facilitation of knowledge sharing between relevant discovery and development teams and across therapeutic areas
* When requested, attend senior management committee meetings for specific Clinical Development Project activities, as agreed with the MSD
* Responsible for effective two way communication with relevant discovery and development teams
* As available, provide clinical strategic input to in-licensing opportunities  
Major Accountabilities
* If delegated by the VP Clinical TA, IMED Clinical VP or MSD, to assume some or all accountabilities of Clinical Project Team MSD where appropriate.
* Accountable to the Clinical Project Team Medical Science Director for the design, and interpretation of human disease biology trials to time, for assigned targets and agents.
* Accountable to MSD for productive handovers of clinical plans to a Global product team (late development) for Phase III trials and consistent alignment of discovery and development activities related to human target and drugs
* Accountable for aligned strategies supporting clinical trials and commercial placement that improve compound risk profiles at investment decisions
* Accountable to MSD and iMED leadership for identifying risks to clinical development and risks of delivery of clinical projects plans
* Ensure consistent practices with the highest ethical standards in compliance with internal SOPs, local regulations and laws     Leadership Capabilities
* Passion for Customers Understands one's customers and uses that insight to provide value
* Thinks Strategically: Quickly identifies and acts on opportunities, combining forethought with action. This is based on an understanding of the external environment and its impact on AZ.
* Acts Decisively: Makes and acts on decisions quickly and effectively and fosters the same in others. This is based on an underlying courage to enable risk taking for the business.
* Drives Performance: Holds self and others accountable for the achievement of performance expectations. Creates an environment that enables others to perform at their best.
* Works Collaboratively: Actively creates and promotes cross boundary collaboration with the aim of archive better business results. Boundaries can exist between individuals, geographies, cultures, teams, functions or organisations.   * Develops People and Organisation: Demonstrates and genuine commitment to the time and effort needed to develop oneself and others.       Internal and External Contacts/Customers
* Strong external awareness, good international scientific and external decision-maker-networks
* Internal customers include medical science director, clinical project director, study delivery, regulatory, product team directors, patient safety, translational strategy and Oncology Early Clinical VP
* Regulatory, Safety, and Pricing/value awareness
* Credibility in scientific, regulatory and commercial environments
* Academic partners, partners in cross-company initiatives, CROs, Public Private Partnership consortia,     Reporting Relationship
Reports to Group Manager and MSD of the Waltham based Clinical Product Team
Direct Reports -- None     Minimum Requirements
* M.D. or equivalent degree
* Board certification or specialist accreditation in Hematology/ Oncology
* At least 5 years of clinical Development expertise, preferably with experience in Hematologic malignancies
* At least 5 years early clinical research expertise and experience, including experience in designing, monitoring, executing and interpreting clinical trials, including understanding of biostatistics and safety reporting
* At least 5 years translational research expertise and experience in small molecule and /or antibody/biologics development
* At least 3 years experience in drug development, including team leadership and strategic influencing, either in academia working with industry or within industry
* Demonstrated leadership experience
* Technical (medical and scientific) experience evaluating targets/agents for in -licensing or internal development
* Ability to be highly discriminating of potential targets and methodologies
* Experience supervising physicians and/or scientific staff in a management or team leader capacity highly desirable. Individuals with less experience may be considered for a Director level role
* Specific International Drug Development Experience preferred
* Proven teamwork and collaboration skills
* Demonstrated ability to lead senior level medical and scientific staff
* Excellent communication skills
* Able to set and communicate a strategic vision
* Strong coaching skills and an appreciation of how clinical development contributes to the broader business.
* Willingness to travel nationally and internationally     Preferred Background
* A physician with a PhD degree or equivalent translational research experience
Enthusiasm and skill reading and discussing basic and translational science literature with discovery scientists
* Notable academic clinical or basic research experience supported by a peer-reviewed publication record
* Solid evidence of team leadership experience
* Successful track record in obtaining grants, regulatory and other external interactions
* Experience in (ideally) several organizations and geographic locations