Location: Malvern, PA
Reports to: Head of Clinical Development- dotted line to Chief Medical Officer
The Medical Director, Infectious Diseases & Immunology will serve as a physician scientist acting as internal subject matter and drug development expert for the infectious diseases & immunology-based business unit of the Company. Medical Director, Infectious Diseases & Immunology will contribute to overseeing the business unit’s clinical research and medical strategy, providing medical leadership, training, and advice for potential or awarded clinical research programs.
Duties and responsibilities
- Contribute to conducting multiple Phase I-IV clinical research trials specific to the drug development process for Ocugen’ s immunology & infectious diseases pipeline
- Design and execute clinical development programs in infectious disease and immunology, specifically Ocugen’s vaccination programs
- Serve as the key partner and contributor for the strategy for Infectious Diseases and Immunology business unit
- Lead and participate in the development of Study Protocols, Investigator’s Brochures, Clinical Development Plans and other key study documents in conjunction with other line functions and with minimal guidance.
- Serve on cross-functional teams for assigned trials, working with other team members to achieve efficient, high-quality study execution.
- Participate in the preparation of regulatory documents in support of regulatory submissions, including clinical section of IND’s and CTA’s, IND safety reports and annual reports for assigned trials, responses to regulatory authorities and Ethics Committees/IRBs, and other documents as appropriate.
- Provide scientific and clinical input to study-related documents and analysis plans including informed consent forms (ICF), clinical research forms (CRF), statistical analysis plans (SAP), clinical pharmacology analysis plans (CPAP), and clinical study reports (CSR).
- Act as liaison between Clinical Development and other internal groups at Ocugen (e.g., Regulatory Affairs, Clinical Operations, Clinical Data Management) for assigned studies.
- Develop and execute life-cycle management plan, lead data generation activities such as medical affairs studies to unmet medical needs and data gaps
- Support Medical Affairs: Work with field medical, Scientific Communication and Publication, Medical Information and Communication teams and provide support including reactive material development to address external stakeholder questions
- Help identify and effectively interact with thought leaders to engage in scientific and medical exchange as well as understand unmet medical needs and data gaps
- Maintain a high level of clinical and scientific expertise in the disease area(s) by reviewing the literature, attending medical/scientific meetings, and through personal interchanges with consultants, thought leaders, investigators and internal stakeholder.
- Author manuscripts and collaborate with cross-functional colleagues and thought leaders to meet publication plan objectives
- Maintain ethical standards of the highest level and have the knowledge and ability to comply with all relevant ethical, regulatory, and legal standards
- May participate in or lead clinical development contributions to due diligence or other business development activity
- As required by program needs, contribute in partnership with Discovery colleagues to the design and implementation of translational strategies
- Supports clinical study teams, monitoring overall study integrity, review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule
- Present at scientific, medical and regulatory meetings globally
- Develop and maintain relationships with academic investigators, pharmaceutical partners/sponsors, KOL’s, and patient advocacy groups
- Responsible for determining and communicating to CMO/Executive Management adequate resource requirements
- Be accountable for study execution and report on study progress, timelines, milestones, and challenges.
- Attend investigator meetings, kick-off meetings and various CRO or other vendor meetings, as required
- Liaise with Regulatory Affairs and Quality to assure adherence to GCPs; maintenance of SOPs and assure site and CRO/vendor audits are completed
- Maintain strong relationships with Principal Investigators (PI) and study personnel
- Additional tasks and projects as requested
- Current or prior license to practice in Medicine
- Infectious Disease and/or Immunology residency and/or fellowship training is a requirement
- 7+ years of relevant industry experience in drug development and clinical research
- 7+ years experience within CRO or pharma/biotech industry, 7 years in a small to mid-size company
- Comprehensive understanding of applicable clinical research regulations
- Demonstrated management and cross-functional collaboration skills with proven experience to drive productivity, efficiency, and quality
- Ability to quickly learn and apply new skills, meet short deadlines and multi-task in a fast-moving environment
- Understand and experience in data management, statistics, and project management necessary for successful study execution
- Advanced understanding of clinical development
- Ability to set priorities, direct multiple projects and implement complex strategies
- Excellent analytical and problem-solving skills
- Proven negotiating experience with internal and external stakeholders
This position operates in an office setting and may include 20% of travel to visit sites or CROs. Job may require incumbent to be available outside of normal hours to handle priority business needs.
This is a largely sedentary role.
Associate Medical Director(s)
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