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The Steely Group http://www.thesteelygroup.com http://www.thesteelygroup.com true
Medical Director, Clinical Development (Rare Diseases)
Cambridge, MA 02142 US
Posted: 03/20/2023 2023-03-20 2023-05-01 Employment Type: Direct Hire Job Category: Operations and Development Job Number: 3428
The Medical Director, Clinical Development (Rare Diseases) delivers medical leadership, providing strategic oversight for assigned clinical development programs and associated clinical trials. Serving as a member of a study team(s), assists with the planning and tactical execution of clinical trial(s), providing necessary input and reviewing clinical protocols for each study and/or trial. As the Medical Director is responsible for protecting the integrity and conduct of clinical studies, will oversee trial conduct, and address questions from clinical sites. Responsible for review of EDC to ensure medical consistency, undertaking clinical data cleaning and timely medical review and interpretation of clinical data for review by the FDA and other regulatory organizations, compilation of the clinical study report(s) and other study-related literature reviews and publications, and/or regulatory submission documents.
- Serves as the medical expert on the scientific fundamentals of the disease indications and the pipeline molecules being studied. Remain current on advances within Rare Diseases through scientific literature, attendance at critical meetings and establish relationships and communications with site investigators and Rare Diseases Key Opinion Leaders (KOLs).
- Provides safety reviews, contributes to safety management plans and data safety monitoring board charters and oversees safety reporting.
- Assesses SAEs and AEs, ensuring the highest medical integrity in the execution and completion of the clinical and regulatory components of the program. Requires a review of coded terms for adverse events, assuring consistency in terms and avoiding failure to identify harms. Once properly coded, frequencies and incidences of adverse events are to be analysed in the search for safety signals. Collaborates with Pharmacovigilance for ongoing safety monitoring, and the review and consultation regarding adverse events.
- Monitors the safety profile (including the clinical assessment) of a portfolio of investigational drugs according to FDA regulations, ICH guidelines and corporate policies and includes the detection and evaluation of safety signals using best quality and Pharmacovigilance (PV) practices.
- Responsibilities include, but are not limited to, the following: provide scientific and medical expertise to define safety questions or issues; develop strategies for safety reviews and analyses; interpret results and determining medical importance of safety issues with the appropriate recommendations or actions.
- Triage adverse event reports and provide medical evaluations of single case reports; providing leadership for PV to include signal detection, risk management and any other activities related to managing the safety profile for assigned products; analyzing, evaluating, and interpreting aggregate adverse event data including signal detection using appropriate tools and methodologies.
- Prepare internal and external reports; contribute to clinical and regulatory documents to include safety sections of protocols, Investigator’s Brochures (IB), Case Report Forms (CRF), Clinical Study Report (CSR) and other documents providing safety information; review case reports (Counsel for International Organizations of Medical Science, 3500As or E2B files) to ensure appropriate selection of alerts for submission to the FDA and other regulatory organizations.
- Responsible for the safety and medical surveillance of products in clinical development to include proactive strategies to prevent risk and promote safety of patients enrolled in investigational trials; participate in cross-functional project team meetings; demonstrate role specific competencies and company values on a consistent basis; mentor junior PV personnel.
- Ensures that all clinical development plans, protocols, reports publications and regulatory documents are of the highest quality and scientific, operational, and ethical standards, they follow compliance with external regulations, and they are completed on time.
- Serve as Medical Monitor and company representative to vendors and collaborators (CROs, PIs, other organizations involved in the implementation of clinical trials).
- Serves as contributor to the development of company’s regulatory strategy. May serve as the medical expert in meetings with the FDA/regulatory authorities.
- Establish process improvements and/or standardization to streamline and enhance consistency across programs in the Clinical Development organization.
- Collaborates with Marketing to evaluate product candidates and to determine production indication, as needed.
- Represent company at high level external meetings.
- May serve on a licensing agreement team.
- Partners with various R&D functions:
- Works with Global Project Leader to ensure all functional areas, especially Clinical Operations, Clinical Supplies and Data Management, are aligned and cooperating, determining that the required resources (people, systems, materials, etc.) for the clinical trials are available and prepared, to meet established timelines. Ensure that all potential study risks are identified, and solutions implemented to avoid delays to the clinical study execution.
- Work closely with Clinical Operations to ensure clinical development program success, ensuring the identification, recruitment, and selection of appropriate clinical investigators and/or contract research organizations (CROs) has been completed.
- Serves as primary clinical resource for Pharmacovigilance, regarding safety monitoring, and the review and consideration of adverse events, for both investigational and commercial products.
- The performance of all other duties, as required.
- This position requires a Medical Degree (M.D.), possessing medical expertise in the therapeutic area of Rare Diseases.
- Must possess at least five to seven years of in-depth knowledge and clinical development experience within the pharmaceutical or biotechnology industry, or seven to nine years of clinical trial experience in an academic setting, collaborating with pharmaceutical sponsors.
- Demonstrated success as a Clinical Development Medical Monitor, providing clinical leadership and strategic medical input, and medical evaluation of safety data for all clinical deliverables. The Medical Monitor must be able to provide medical expertise in the management (including the design, monitoring and implementation) of investigational drug development Phases I-III. Experience must include, but not be limited to, designing clinical trials, reviewing and analyzing clinical data with an understanding of biostatistics as it is relevant to the design and analysis of the study(s), product safety reporting, INDs, and NDA submission.
- Possesses a thorough knowledge and understanding of clinical development in various therapeutic areas (Immunology is required; Gastroenterology, Dermatology, Allergy, and Rheumatology a plus), the impact of pharmacologic agents on humans, nonclinical (toxicology) and regulatory requirements for testing new therapies in humans.
- Possesses proficiency with pharmacovigilance programs including signal detection and safety databases (i.e. Adverse Event Reporting Systems) supportive of drug safety and Medical Dictionary for Regulatory Activities (MedDRA).
- Demonstrated success of advancing and completing clinical trials successfully.
- Ability to manage multiple studies (as necessary), while efficiently and effectively utilizing manpower to manage various factors and meeting predetermined clinical study milestones.
- Must remain current in clinical development knowledge and expertise, with a constant awareness of any scientific advances that may impact company’s drug development process, as well as any changes to drug regulations and FDA/ICH guidelines.
- Have previously worked productively with regulatory bodies, demonstrating an expertise in clinical data interpretation. Will also have presented clinical study outcomes at scientific meetings and conferences.
- Experience creating a scientific methodology that will ensure an unbiased and well-controlled experimental design, methodology, analysis, interpretation and reporting of study results.
- Recognizing the value of working cross-functionally, demonstrated ability to operate collaboratively to achieve organizational alignment and collective decision-making on approach and achievement of corporate objectives, maintaining an awareness of regulatory requirements, as well as commercial objectives.
- Strategic thinker, able to create and implement short- and long-term plans, identifying and utilizing the necessary resources for meeting all pre-determined timelines and outcomes.
- Strong analytical skills and problem-solving capabilities.
- Highly organized with strong attention to detail, clarity, accuracy and conciseness.
- Demonstrated ability to interact successfully in a dynamic and culturally diverse workplace. Must be an experienced, influential and credible professional who is able to establish and maintain effective and successful working relationships both internally with all Staff, and with external technical and medical experts, in a collaborative and cohesive manner.
- Able to work collaboratively in a team-oriented environment, taking on responsibility and accountability for assigned programs.
- Able to balance strategic approach with the needs of an organization requiring hands-on work, while addressing competing priorities that may require, at times, a sense of urgency.
- Must have excellent communication and presentation skills (verbal and written). Serving as a subject matter expert and resource, must be able to effectively present to and connect with the members of an audience, which may be made up of KOLs, investigators, representatives of a regulatory agency, patients, and peer group members.
- Experience with data visualization systems and safety systems (i.e. ARGUS, ARIS-g) are preferred
- Ability to read printed materials and written information on a computer screen is required.
- Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).
- As our client is a global company, this role may be required to attend and participate in business meetings in person or via conference call, that will be scheduled in the evening or early morning.
- Business Travel: This role requires the incumbent to travel, which will be primarily domestic, however the Medical Director, Clinical Development may have to occasionally attend meetings at Corporate Headquarters in Japan, and attend international medical conferences for example, advisory boards, etc. Travel will be scheduled based upon the needs of the business, up to 30% of the time.