Senior Vice President, Head of Development

3 weeks ago

Plymouth Meeting, United States Harmony Biosciences LLC Full time

Harmony Biosciences is recruiting for a Senior Vice President, Head of Development in our Plymouth Meeting location. This position provides an exciting opportunity for an experienced pharmaceutical physician to build and lead a Development organization in a dynamic environment at an innovative pharmaceutical company focused on rare neurological disorders with several development programs in various stages of development ranging from pre-clinical to late development to regulatory submission stage.

Responsibilities include but are not limited to:

  • Strategic leadership for all the Development activities in the R&D ranging from pre-clinical stage of development thru Regulatory submission and post-approval studies
  • Mentor and support various Departments reporting directly into this position that may include (but not limited to) Clinical Strategy, Clinical Operations, Regulatory Affairs, Medical Affairs, Pharmacovigilance, Biostatistics, R&D portfolio management, etc.,
  • Work closely with the Franchise Head and execute the vision for the company.
  • Partner with Business Development team to evaluate opportunities and build innovative portfolio of assets.
  • Allocate and manage resources across the Development areas and ensure the programs are progressing on-time and on-budget.
  • Provide strategic input and 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).
  • Provide updates on a regular basis to Senior Management (and the Board as appropriate) on the progress of the clinical development programs.
  • Perform other duties as assigned.

Qualifications:

  • Experienced pharmaceutical physician (MD or DO) with 15+ years in the industry, with 5+ of them in leadership roles in Research and Development
  • US Board certification in either Neurology or Psychiatry is a must.
  • Broad areas of expertise ranging from pre-clinical development to late stage development including expertise in post-approval programs and medical affairs.
  • Demonstrated track record of success in leading clinical development teams toward product approvals; experience in orphan/rare drug development is highly desired but not required.
  • 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
  • Ability to both lead and 'roll up one's sleeves' as part of an emerging company with a 'one team' attitude to do what it takes to achieve a common goal
  • Team orientated and ability to work collaboratively towards common objectives in a matrix organization.
  • 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.
  • 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 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 culture

Want 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.com

Harmony Biosciences, LLC is an Equal Opportunity, e-Verify Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

Recruitment 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.

#LI-DNP

  • Vice President, Ceded Reinsurance

    2 weeks ago

    Plymouth Township, Montgomery County, United States Safety National Full time

    Stop searching. Start growing. It's time to build a meaningful career where you can grow, your ideas can thrive, and you are recognized and valued. Join a team committed to your excellence, and apply to Safety National today! This opportunity is in the Ceded Reinsurance Department. The Ceded Reinsurance department's mission is to protect the company's...

  • Senior Land Development Analyst

    3 weeks ago

    Plymouth, Minnesota, United States Lennar Homes Full time

    OverviewLennar Homes is a leading homebuilder dedicated to making a positive impact and creating an extraordinary experience for homeowners, communities, and associates. As a Senior Land Development Analyst, you will play a critical role in the success of our company.About the JobWe are seeking a highly skilled and motivated Senior Land Development Analyst...

  • Senior Care Specialist in Whitemarsh, PA

    3 weeks ago

    Plymouth Meeting, Pennsylvania, United States Sunrise Senior Living Full time

    About the RoleWe are seeking a Senior Care Specialist to join our team at Sunrise Senior Living in Whitemarsh, PA. As a key member of our care team, you will play a vital role in providing exceptional care and services to our residents.Job SummaryThe Senior Care Specialist is responsible for delivering high-quality care and support to a consistent group of...

  • Senior Care Medication Manager

    3 weeks ago

    Plymouth Meeting, Pennsylvania, United States Sunrise Senior Living Full time

    At Sunrise Senior Living, we are passionate about delivering high-quality care with a personal touch. Our dedicated team of healthcare professionals is committed to championing the quality of life for all seniors.About the RoleWe are seeking a skilled and compassionate LPN Medication Care Manager to join our team. As a Medication Care Manager, you will be...

  • Deputy Vice Chancellor Education and Student Experience

    2 weeks ago

    Plymouth, United States CLevelCrossing Full time

    Deputy Vice Chancellor Education and Student ExperienceLocation: Plymouth, MN, United StatesPosted on: Aug 03, 2021Profile:Description:At the University of Plymouth, we have a proud 150-year heritage and a sustained legacy of success. We are an international university that advances knowledge and transforms lives. We have embarked upon a ten-year strategy...

  • Deputy Vice Chancellor Education and Student Experience

    2 weeks ago

    Plymouth, United States clevelcrossing.com - Jobboard Full time

    Deputy Vice Chancellor Education and Student ExperienceLocation: Plymouth, MN, United StatesPosted on: Aug 03, 2021Profile:Description:At the University of Plymouth, we have a proud 150-year heritage and a sustained legacy of success. We are an international university that advances knowledge and transforms lives. We are achieving continued positive uplifts...

  • Senior Land Development Attorney

    3 weeks ago

    Plymouth Meeting, Pennsylvania, United States Alevistar Legal Search Full time

    Job Overview: Alevistar Legal Search is seeking a highly skilled Senior Land Development Attorney to join their team. This role will involve representing clients in PA & NJ, with a focus on zoning and land use law.">About the Role: As a Regional Zoning and Land Use Lawyer, you will be responsible for advising developers, homebuilders, homeowners, and...

  • Deputy Vice-Chancellor

    2 weeks ago

    Plymouth, United States CLevelCrossing Full time

    Deputy Vice-Chancellor - Research and InnovationLocation: Plymouth, MN, United StatesPosted on: Mar 21, 2022ProfileDescription:At the University of Plymouth, we have a proud 150-year heritage and a sustained legacy of success. We are an international university that advances knowledge and transforms lives. We are achieving continued positive uplifts in all...

  • Compassionate Caregiver

    3 weeks ago

    Plymouth Meeting, Pennsylvania, United States Sunrise Senior Living Full time

    Job OverviewSunrise Senior Living is a renowned provider of quality care and services to seniors. We are committed to creating a supportive environment that allows our residents to thrive.The Care Manager plays a vital role in delivering exceptional care and services to our residents. This position involves building meaningful relationships with seniors and...

  • Caregiver Assistant

    3 weeks ago

    Plymouth Meeting, Pennsylvania, United States Sunrise Senior Living Full time

    Sunrise Senior Living is a champion of quality life in senior care, with over 30 years of experience. We believe our team members are our greatest resource and are looking for people who share our commitment to provide quality care for seniors and their families.Job SummaryWe are seeking a highly dedicated and compassionate Care Manager to join our team at...

  • Head of Strategy

    3 weeks ago

    Plymouth, United States Philips Full time

    Job Title Head of Strategy – Image Guided Therapy Devices Job Description Head of Strategy- IGTD As Head of Strategy for Image Guided Therapy Devices (IGTD) you will play a pivotal role in shaping the strategic direction of the business unit focusing on accelerating growth, strengthening competitive market position globally, identifying strategic...

  • Senior Executive Assistant

    3 weeks ago

    Plymouth, United States Harbor Health Services, Inc. Full time

    Harbor Health Services is an innovative, growing, mission-based organization that lives, serves and collaborates with our community members to achieve our mission to help individuals reach their full potential through access to local, affordable services that promote health. We are currently seeking an extremely talented Senior Executive Assistant to join...

  • Senior Care Professional

    3 weeks ago

    Plymouth, Michigan, United States Sunrise Senior Living Full time

    About Sunrise Senior LivingSunrise Senior Living is a leading provider of senior care services, dedicated to delivering high-quality care and enriching experiences for our residents. With over 30 years of experience, we have established ourselves as a trusted partner in the senior living industry.Job SummaryWe are seeking a compassionate and skilled Senior...

  • Head of Powertrain Development Engineering

    4 weeks ago

    plymouth, United States MAHLE, Inc Full time

    MAHLE Powertrain is a global engineering consultancy and part of the wider MAHLE Group, specializing in the design, development, and integration of both advanced internal combustion engines and electric powertrain systems. Leading the development in ICE, Electro-mobility, and future propulsion technologies, the goal is to optimize powertrains, systems, and...

  • Head of Powertrain Development Engineering

    4 weeks ago

    plymouth, United States MAHLE, Inc Full time

    MAHLE Powertrain is a global engineering consultancy and part of the wider MAHLE Group, specializing in the design, development, and integration of both advanced internal combustion engines and electric powertrain systems. Leading the development in ICE, Electro-mobility, and future propulsion technologies, the goal is to optimize powertrains, systems, and...

  • Head of Powertrain Development Engineering

    1 month ago

    Plymouth, United States MAHLE, Inc Full time

    MAHLE Powertrain is a global engineering consultancy and part of the wider MAHLE Group, specializing in the design, development, and integration of both advanced internal combustion engines and electric powertrain systems. Leading the development in ICE, Electro-mobility, and future propulsion technologies, the goal is to optimize powertrains, systems, and...

  • Head of Powertrain Development Engineering

    1 month ago

    plymouth, United States MAHLE, Inc Full time

    MAHLE Powertrain is a global engineering consultancy and part of the wider MAHLE Group, specializing in the design, development, and integration of both advanced internal combustion engines and electric powertrain systems. Leading the development in ICE, Electro-mobility, and future propulsion technologies, the goal is to optimize powertrains, systems, and...

  • Senior Construction Supervisor

    3 weeks ago

    Plymouth Meeting, Pennsylvania, United States Danella Companies Full time

    About Danella CompaniesDanella Companies, a leading utility construction company, is seeking an experienced Senior Construction Supervisor to oversee field operations in the Philadelphia region. As a respected contractor in the industry, we pride ourselves on delivering top-notch services and fostering a culture of excellence.Job DescriptionThe Senior...

  • Senior Care Professional

    19 hours ago

    Plymouth, Michigan, United States Sunrise Senior Living Full time

    About Sunrise Senior LivingSunrise Senior Living has been a pioneer in senior care for over 30 years, championing quality of life for all seniors. Our team members are our greatest resource, and we're looking for passionate individuals who share our commitment to providing exceptional care and services.CompensationWe offer competitive compensation based on...

  • Senior Dining Services Manager

    3 weeks ago

    Plymouth, Massachusetts, United States Sunrise Senior Living Full time

    Sunrise Senior Living is a leading provider of senior care services, and we are seeking a skilled Senior Dining Services Manager to join our team.Job DescriptionThe Senior Dining Services Manager will be responsible for overseeing the dining services at our community, ensuring that residents receive high-quality food and service. This role requires strong...