Reference #: 1376
Harmony Biosciences is recruiting for a Vice President, Clinical Strategy - Epilepsy in our Plymouth Meeting, PA location.This position provides an exciting opportunity for an experienced pharmaceutical physician with expertise in epilepsy to build and lead a Clinical Strategy team in a dynamic environment at an emerging pharmaceutical company with several development programs in the clinic, and additional ones planned.In this role you will be responsible for leading the design and execution of the clinical development programs, including the formulation of clinical development strategy, creation of development plans, designing clinical trials, and overseeing the team of medical and scientific directors during the conduct of the trials for Harmony's epilepsy pipeline. This role will also involve direct, hands-on monitoring of clinical trials at times in addition to the supervisory role. This position will work closely with other key functional areas involved in the development enterprise, including Clinical Operations, Biostatistics, Regulatory Affairs, Project Management, Pharmacovigilance, among others.
This role shares responsibility with Clinical Operations and Project Management in the creation of clinical development timelines and budgets and be accountable for the execution of these programs within these timelines and budgets and will have oversight of safety reporting for both clinical development programs and supporting Pharmacovigilance on post-marketing safety activities.
This is a high visibility role for the company and the incumbent will interact with Harmony's Senior Leadership Team, and provide clinical development updates to the Management Team, as needed. The position will also interact with external stakeholders in the medical and scientific community (KOLs, Investigators) and be a key contributor and participant in meetings with regulatory authorities.
Responsibilities include but are not limited to:
Lead the creation of clinical strategy and development plans for the epilepsy pipeline for Harmony Biosciences.
Oversee and lead the design and execution of Harmony's epilepsy clinical trials.
Supervise the drafting, review and finalization of clinical trial protocols with direct, hands-on participation in the development of these protocols, as needed.
Oversee the team of medical and scientific directors during the conduct of clinical trials and assist with medical monitoring as needed.
Work closely with the Clinical Operations team in the design and execution of clinical trials and participate in CRO selection and selection of other key vendors.
Collaborate with Clinical Operations and Portfolio Project Management in establishing clinical trial timelines and budgets.
Collaborate with Regulatory Affairs as the subject matter expert on medical content and trial design in the preparation of Regulatory documents for the development programs; also work with Regulatory Affairs and be a key contributor in the preparation and participation of meetings with regulatory authorities.
Collaborate with Biostatistics to appropriately estimate clinical trial size, power, and creation of statistical analysis plans (SAPs) for the clinical trials.
Supervise the safety reporting from the clinical development programs and provide support to Pharmacovigilance for post-marketing safety activities.
Play an active role with the team interacting with key external stakeholders of the development programs (e.g. KOLs, Investigators, patient advocacy organizations, among others).
Evaluate new assets for growing the pipeline and interact with external entities as needed for Business Development activities.
Perform other duties as assigned.
Supervisory Responsibilities:This position has supervisory responsibilities of Harmony's Clinical Strategy team for the epilepsy programs .
Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.
Interview ng, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
Qualifications:
Medical Degree (MD or DO) required; Neurologist with a specialization in Epilepsy and/or extensive clinical development expertise in epilepsy is required
12+ years' experience within the pharmaceutical industry; 5+ years in leadership roles in Clinical Strategy/Development
Demonstrated track record of success in leading clinical development teams toward product approvals; experience in orphan/rare drug development is desired
Deep knowledge in clinical trial design and methodology
Solid understanding of regulatory principals of the drug development process and regulatory strategy such that clinical trials can lead to optimal labeling
Demonstrated experience interacting with FDA along the drug development process (Pre-IND meetings, EOP2, Pre-NDA meetings) and during labeling negotiations
Ability to process complex clinical and regulatory issues and design creative approaches to address these challenges
Competency in assessing risk/benefit of different approaches to development programs, balancing these issues, and putting risk mitigations strategies in place
Decisive and demonstrated ability to make tough decisions, articulate the rationale for making the decision, and be able to defend one's position with poise and professionalism
Excellent verbal and written communication skills with experience interacting with multiple senior level internal and external stakeholders
High ethical standards and dedicated to excellence in the conduct of clinical trials while protecting patient safety
Physical demands and work environment:
Travel is estimated to be 20% of the time for this position. Travel may be both domestic and international.
While performing the duties of this job, the noise level in the work environment is usually quiet.
Specific vision abilities required by this job include close vision.
Manual dexterity is required to use computers, tablets, and cell phone.
Continuous sitting for prolonged periods.
What can Harmony offer you?
Medical, Vision and Dental benefits the first of the month following start date
Generous paid time off and Company designated Holidays
Company paid Disability benefits and Life Insurance coverage
401(k) Retirement Savings Plan
Paid Parental leave
Employee Stock Purchase Plan (ESPP)
Company sponsored wellness programs
Professional development initiatives and continuous learning opportunities
A certified Great Place to Work for six consecutive years based on our positive, values-based company cultureWant to see our latest job opportunities? Follow us on LinkedIn!
Harmony Biosciences is a pharmaceutical company headquartered in Plymouth Meeting, PA. The company was established in October 2017 with a vision to provide novel treatment options for people living with rare, neurological disorders who have unmet medical needs. For more information on Harmony Biosciences, visit www.harmonybiosciences.comRecruitment agencies please note: Harmony Biosciences will only accept applications from agencies/business partners that have been invited to work on a specific role. Candidate Resumes/CV's submitted without permission or directly to Hiring Managers will be considered unsolicited and no fee will be payable. Thank you for your cooperation.Harmony Biosciences, LLC is an Equal Opportunity, e-Verify Employer. All qualified applicants will receive equal consideration for employment without regard to race, color,
