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Director, Clinical Development Scientist
Remote Remote, NC 00000 US
Job Description
The Director, Clinical Development Scientist (CDS) in endocrinology and Bone metabolism TA may lead a cross functional team in the design and execution of a clinical study. The person in this position may provide input into the global clinical development plans and strategy for different indications. The job holder supports assigned clinical development physician(s) and the therapeutic area head with deliverables necessary for effective and efficient clinical development plan design and execution and therapeutic area strategy.
Essential Functions: • Leading a team in preparing clinical study-related documents, including protocols, charters, statistical summary reports, meeting presentations, publications, and clinical sections of regulatory documents (may manage several studies in parallel).
• Leading a study team to design a clinical protocol, including engaging with relevant internal and external stakeholders; responsible for preparing materials and protocol defence presentation for protocol review. Represent the clinical study team at the clinical sub-team.
• May supervise and develop clinical development scientists and/or fellows; Lead a team in preparation of clinical study-related documents including protocols, charters, statistical summary reports, meeting presentations, publications, and clinical sections of regulatory documents
• Participating in Investigator meeting planning and execution and/or on-site initiation meetings
• Oversight of the execution of clinical trials; Monitor, clean, analyze and review safety and efficacy data to establish the presence or absence of trends and follow up as appropriate.
• Leading a team in study oversight, including country and site selection, site training and start-up and data monitoring; data analysis and presentation expertise required. Depending upon specific expertise in translational science may lead a translational sub-team of the clinical team.
• Liaising with other functions to design external expert consultations and contribute to developing study concepts and designs, protocols, and study essential documents. Engage with clinical investigators on clinical studies to enable quality clinical execution, analyze and interpret clinical data, and collaborate with the broader team to define clinical and therapeutic area strategy. Engage with investigators, site staff, contract research organisations (CROs), and site monitors to maintain enthusiasm and support enrollment in ongoing clinical studies. Where appropriate, serve as the Subject Matter Expert for identification, translation, inclusion, implementation, and reporting related to liquid, tissue and/or imaging endpoints.
• Leading the execution of clinical trials and associated data collection activities, guiding the clinical study team related to: o Scientific matters related to the asset and/or the indication
o country and site feasibility assessments and selection
o site training and oversight
o patient recruitment
o ongoing data monitoring
o study closeout • Maintaining awareness of internal and external developments (scientific, clinical, competitive, and regulatory) that could impact the development plan, including attendance at major scientific conferences, participation in competitive intelligence activities, and periodic literature review Critically evaluate available information about diseases of interest to the therapeutic area and the competitive landscape and synthesize information succinctly to support dissemination and incorporation into clinical development programs, asset plans and therapeutic area strategy
• Helping to determine the appropriate advisory boards experts
• Providing support for business development activities, such as due diligence and research collaborations
• May serve as the Translational Science lead for one or more programs
Education and Experience: • Advanced scientific degree (M.S., Ph.D., Pharm D., MPH or similar degree)
• Preferred: Advanced knowledge in the Bone met and endocrine space.
• 5+ years of industry experience in clinical development is preferred
Knowledge, Skills and Abilities: • Understanding of general (and specific) therapeutic principles • Knowledge of the principles of clinical research methodology, statistics, data analysis and interpretation
• Familiar with scientific literature searches and weighing of quality peer-reviewed data
• Ability to communicate with internal and external stakeholders orally and in writing
• Basics of strategic vs. tactical thinking
• Experience in preparing clinical trials applications and following up on clinical trials’ monitoring activities.
• Previous experience in working on regulatory documentation and clinical trial reports preparation
• Experience interacting with varying levels of internal/external management and/or academicians and/or clinicians and/or scientists, etc.
• In-depth knowledge of the multidisciplinary functions involved in a company’s drug development process, e.g., clinical operations, biostatistics, regulatory, commercial operations, etc. and can proactively integrate multiple perspectives into the clinical development process for best-end results
• The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation, to use a computer; engage in communications via phone, video, and electronic messaging; engage in problem-solving and non-linear thought, analysis, and dialogue; collaborate with others; and maintain general availability during standard business hours.
Pay Rate Range: $100-117/hr depending on experience
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
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