Position: Clinical Development Lead. This role is a Senior Director level position, with potentially some flexibility based on the candidate's experience and qualifications.
Position Summary: Pulmovant is seeking a highly motivated hands-on physician leader who will be responsible for the design and execution of clinical trial activities to support the development of mosliciguat, including study design, protocol development, execution and data interpretation. The candidate will be the primary source of medical accountability and oversight for clinical trials and will serve as a medical lead. The candidate will liaise between investigators and the internal study team and will maintain established relationships with key opinion leaders as well as Health Authorities. Scope of responsibility will include a leading role on the execution of the Phase 3 trial and may also include indication lead activities for additional indications as the program is further developed.
KeyDuties and Responsibilities- Provide clinical and scientific input to study design, protocol concepts and development, statistical analysis plans and reporting to drive high value clinical data.
- Medical strategic oversight and accountability for the formulation of study designs, protocol development, and regulatory documents in collaboration with cross-functional team.
- Provide clinical leadership of trial execution and management of clinical studies with a focus on the phase 3 trial. Provide clinical leadership in the conduct of clinical activities including executional delivery of the study, recruitment, site activation, data review analysis, and reporting that conforms to the highest ethical, safety and quality standards and in compliance with GCP and regulatory standards.
- Remain current on the therapeutic landscape, including regulatory in the relevant therapeutic areas through review of the scientific literature, interactions with key opinion leaders and other external experts and attendance at relevant scientific meetings, to provide input and guidance for the strategic direction of programs.
- Collaborate with external opinion leaders and Principal Investigators and internal clinicians, translational sciences and clinical operations to ensure appropriate study designs are achieved for successful implementation of data analyses and accomplishment of intended study outcomes.
- Maintain current awareness of development and regulatory issues related to competitive compounds in development and how our program(s) or portfolio fits into the competitive landscape.
- Attend and present at investigator meetings and site initiation visits as applicable.
- Provide clinical leadership and contribute to the preparation of protocols, Clinical Study Reports, Annual Reports and other safety reports, Health Authority pre-meeting packages, Investigator Brochures, and other periodic clinical reports.
- Participates with team members to prepare abstracts, manuscripts, and presentations for external meetings as well as author clinical sections of regulatory documents (IB, IND sections)
- Maintains knowledge of ICH-GCP, external regulations and procedures.
Skills, Qualifications and Requirements - MD/DO degree or equivalent is required
- Board Certification or Board Eligibility in internal medicine with subspecialty training or experience in drug development in cardiopulmonary / respiratory medicine is highly desirable
- Minimum of 5 - 7 years experience conducting clinical research trials in the biopharmaceutical industry, ideally with late phase experience
- Hands on experience in protocol development and clinical trial monitoring
- Experience with U.S. and European Health Authority interactions and submission of clinical regulatory documents is desirable
- Strong written and verbal communication skills; willingness to engage with investigators, key opinion leaders, external advisors, and regulatory authorities; and ability to effectively give presentations at conferences, advisory meetings, and other public forums
- Willingness to educate and mentor internal and external colleagues and collaborators
- Engaged, hands-on, independent, and goal-oriented mentality; willingness to work in highly dynamic work environment and embrace uncertainty
- Self-motivated; strong commitment to follow up on tasks and action items; organizational, analytical, and problem-solving skills; risk identification and management; creative and innovative thinking all highly desirable
- Strong ability to work within and lead and motivate a cross-functional matrixed team
- The requisite scientific acumen and communication skills to influence and collaborate with key scientific, regulatory, and business leaders
- Sound strategic, clinical, technical, operational, and ethical judgment with uncompromising integrity
- Ability to travel as needed
