Director-Sr Director Clinical Development - Pulmonary Focus - Remote

Nwrpros Seattle , WA 98126

Posted 3 weeks ago

Apply

This Job is not relevant Tell us why

Position Overview: Director/ Sr. Director, Clinical Development, is responsible for ensuring that from a clinical development perspective, the Company assets are aligned for success, leading up to launch. The Director/ Sr. Director, Clinical Development, does this by bringing together therapeutic area landscape knowledge, US and Global external expert insights, US/Global healthcare dynamics, understanding of the regulatory environment, and the clinical development experience to translate medical needs and gaps into an integrated strategic clinical development plan that enables the clinical development role in the Company’s overall market approach, while informing medical affairs efforts to support this goal.Essential activities to be accomplished: collaborates cross functionally across within the Company functions such as Clinical Operations, Medical Affairs, Field Based Medical, Regulatory Affairs, and Market Access; creates, executes, measures, and adapts the clinical development strategy, including trial strategy and design; works with Medical Affairs to develop the appropriate communications for FBM, Patient Advocacy and Professional Relations, appropriate publication strategy and plans.Key Responsibilities:

Cross collaborates with Sr. VP Clinical Development, VP Clinical Operations, VP Medical Affairs, and Sr. VP, Program Management to co-create the clinical development plan to ensure that market needs are met, including clinical trial design, clinical indication, choice of potential comparator, implementation of imaging and biomarker plan.
Ensures external experts' and patient’s feedback and input to the overall clinical development plan and specific clinical protocols.
Implements excellence in clinical development as well as the generation of a consolidated medical strategy and integrated evidence plan to address meaningful gaps internally and externally.
Design the clinical development program taking into account the needs of patients, physicians, and payers. Oversees product development throughout the lifecycle from early clinical development through approval, launch and loss of exclusivity.
Collaborates with Medical Affairs to promote synergies throughout the product lifecycle to ensure the success of launches and timely execution of prioritized evidence generation initiatives.
Responsible for providing clinical development insights into the Target Product Profiles, Clinical Development Plans, Pediatric Investigational Plan, core Clinical Trial Protocols, Project Analysis and Data Management Plan, Investigator Brochure, Annual Safety Report / IND Safety Reports, preparation for the Milestones Start of Development, Proof of Clinical Principle, Release of Full Development, and input into regulatory strategies and labeling discussions.
Provides medical input in regulatory meetings and contributes to the submission strategy, regulatory dossiers, and safety issues.
Contributes to the development of advisory boards, adjudication committees and Safety Data Monitoring boards.
Collaborates with Medical Affairs to support profile of external experts for Field Based Medicine interaction.

Key requirements for this role are:

History of a strong clinical and research background preferably in ILD, including IPF and PPF and pharmaceutical industry clinical development experience.
MD/DO (5 years pharma exp. plus prior clinical exp.),
APRN (5-8 years pharma exp. plus prior clinical exp.),
PhD (8-10 years pharma exp.)
Demonstrated experience in developing and executing clinical development plans, medical affairs strategy and tactics, business process improvement, product launch planning, and integrated evidence generation
Deep scientific knowledge of the US/Global healthcare system and regulatory landscape, including the needs of providers, patients, payers, and caregivers
Ability to collaborate and lead with executive presence, positively influence performance excellence, and encourage innovation across all US therapeutic areas and levels
Ability to translate science into clinical patient value and operate within SOPs and working instructions
Strong oral and written communication skills as well as the ability to present complex information to large scientific / academic audiences as well as to the media
Strong understanding of the shifting healthcare environment, medical, pharmaceutical and payor market dynamics, portfolio growth
Ability to manage multiple projects and identify risks in a fast-paced environment with a drive for results and sense of urgency to meet medical market needs
Ability to travel as required by the nature of the role including conferences and KOL meetings
Self-motivated, independent, and able to work effectively in a small team and fast-paced environment

Strong organizational and time-management skills, with the ability to prioritize and manage multiple projects simultaneously

Show Full Description

See how you match
to the job

Upload my resume

Download the
LiveCareer app and find
your dream job anywhere

Similar Jobs

View All

Want to see jobs matched to your resume?
Upload One Now!

Apply