Medical Director
Medical Director level role that provides strategic oversight for clinical development programs and associated clinical trials.
- Ensures the highest medical integrity and conduct of clinical studies in the execution and completion of the clinical and regulatory components of the program.
- Enhances and streamlines programs in the Clinical Development organization.
- Develops proactive strategies to prevent risk and promote safety of patients enrolled in investigational trials.
Planning and Execution
- Ensures the highest medical integrity and conduct of clinical studies in the execution and completion of the clinical and regulatory components of the program.
- Ensures medical consistency of clinical data for submission to the FDA and other regulatory organizations.
- Oversees the safety profile of a portfolio of investigational drugs in accordance with corporate policies and legal regulations.
Financial Outcome
- Ensures consistency of coded terms for adverse events and develops strategies to avoid failures to identify harm.
- Collaborates with Marketing to evaluate product candidates and to determine production indication.
Operation and Improvement
- Enhances and streamlines programs in the Clinical Development organization.
- Identifies potential study risks and implements solutions to avoid delays to the clinical study execution.
- Ensures all clinical development plans, protocols, reports publications and regulatory documents are of the highest quality and scientific, operational and ethical standards, in compliance with external regulations, and completed on time.
Innovation
Develops proactive strategies to prevent risk and promote safety of patients enrolled in investigational trials.
Talent Development and Organization Growth
Facilitates continuous learning and knowledge transfer throughout the duration of the project, as well as upon its completion.
External / Internal Relationship
- Collaborates cross-functionally to achieve organizational alignment and collective decision-making on approach and achievement of corporate objectives.
- Represents organization at high level external meetings.
Educational Requirements
Medical Degree (M.D.), possessing medical expertise in the therapeutic area of oncology or non-oncology is required.
Experience
- 5 to 7 years of in-depth knowledge and clinical development experience within the pharmaceutical or biotechnology industry, or 7 to 9 years clinical trial experience in an academic setting, collaborating with pharmaceutical sponsors.
- Experience as a Clinical Development Medical Monitor providing clinical leadership, strategic medical input, and medical evaluation of safety data for all clinical deliverables.
- Experience working with regulatory bodies and creating scientific methodology for unbiased and well-controlled experimental design, methodology, analysis, interpretation and reporting of study results.
Other Skills / Abilities and Working Conditions
Skills and Abilities
Technical Skills
- Possesses a thorough knowledge and understanding of clinical development in various therapeutic areas, 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 supportive of drug safety and Medical Dictionary for Regulatory Activities (MedDRA).
Cognitive Skills
- Strong analytical skills and problem-solving capabilities.
- Strategic thinker with ability to create and implement short- and long-term plans to meet timelines and outcomes.
Language / Interpersonal Skills
- Excellent communication and presentation skills.
- Ability to effectively present technical information across the organization.
Other
Working Conditions
Physical Demands
Work is generally sedentary in nature, but may require standing, walking, grasping, and lifting / moving up to 15 pounds
Work Environment
The noise level in the work environment is usually quiet.
Business Travel
This role requires the incumbent to travel up to 30% of the time.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of knowledge, skills and / or abilities required.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential function of this role. (US Only)
Medical Director
Real time Medical Monitoring of clinical studies: ensure medical validity of each individual primary endpoint as well study subject safety, while ensuring medical issues are identified early. Medical point of contact for all internal and external stakeholders: Interact with the investigators as need...
Director, Medical Affairs
The Director of Global Medical Affairs Strategy, Ophthalmology is a key member of the global medical affairs team who will work closely with medical affairs and cross-functional stakeholders to implement key aspects of the global medical affairs strategy for ophthalmology. Medical Director and/or Me...
Medical Director, Primary Care
CHA is recruiting a full time primary care physician leader for the Medical Director opportunity at our. Medical Director will practice clinically and have dedicated time devoted to leadership and management of the provider team. The position carries the opportunity for a Harvard Medical School (HMS...
Medical Director
The Director will have a highly visible role in practice transformation and implementation of the medical home model and be a leader in healthcare delivery innovation. Harbor provides medical, behavioral health, dental, and support services to more than 34,000 patients in Boston, the South Shore, an...
Trauma Medical Director - Chief of Acute Care Surgery
The Lahey hospital and Medical Center, is seeking outstanding candidates for the position of Trauma Medical Director (TMD) and Director of Acute Care Surgery with an exemplary record of patient care and expertise in Trauma, Acute Care, and Surgical Critical Care. Lahey Hospital & Medical Center*...
Medical Director, US, Rare Diseases
Build and maintain relationships with NA key opinion leaders and HCPs in concert with the Head of Field Medical, the MSL manager, field medical team, and the Global Medical Director . The Medical Director (or Associate) Dermatology NA is part of the Medical Affairs HIDO* Strategy team. Aligning...
Medical Affairs Medical Director, Pain
The Medical Affairs Medical Director will provide medical leadership for the Medical Department in the Pain therapeutic area. Acts as the local medical contributor and reviewer/approver of Field Medical Material (proactive and reactive), Promotional Material, Access Material and Medical Information ...
Clinical Development, Associate Medical Director, Pain
Vertex Pharmaceuticals is searching for an Associate Medical Director who will be assigned to clinical trials within the Pain Program. You will work as part of multidisciplinary cross-functional study teams on clinical trial design and execution and serving as the primary or back-up Medical Monitor ...
Sr. Medical Director, MassHealth (hybrid)
Under the general direction of the Director of the Office of Clinical Affairs (OCA)/Chief Medical Officer or designee, the Sr. Reports to the MassHealth Chief Medical Officer/Director of the Office of Clinical Affairs (OCA). Participate in or lead Advisory Board meetings and other OCA, MassHealth an...
Director, Global Medical Affairs Lead
The Global Medical Affairs Lead (GMAL) serves a critical role by supporting Dyne’s Neuromuscular Disease programs (NMD). Internally, the GMAL is accountable as the Global Medical Affairs representative on key cross-functional, and highly visible teams including Program Development Teams, Clinical De...