Therapeutic Area Head AF
Job Title: SVP, Atrial Fibrillation, Therapeutic Area Head Department : Clinical Science
FLSA Status: Exempt Reports To: Jay Edelberg
Effective Date: July 2020
Being a part of MyoKardia means you are a pioneer at heart, a go getter, a part of something meaningful . We push the boundaries, embrace uncertainty and challenge conventional thinking to make the biggest impact on people's lives - because we believe that a better solution is out there. We roll up our sleeves and get to work on making things happen - when the outcome of our work changes lives, action is a moral must. Each of us has a hand in shaping the future of our company, our industry and people's lives because the passion in each and every one of us is what makes the difference.
If you are someone who dares to explore the unknown; who takes action in the face of uncertainty; who is passionate and driven about making a real difference in people's lives... then you belong at MyoKardia .
This newly created role the VP/SVP, Atrial Fibrillation (AF) Therapeutic Area Head (TAH) will report directly to the Chief Medical Officer. The advances led by the TAH will have impact beyond the specific therapeutic area and should enhance the programs across the MyoKardia portfolio.
This role will design and lead the entire AF disease area strategy as well as strategy/indications related to atrial cardiomyopathy, and systolic dysfunction (atrial and ventricular); planning and execution for clinical science and drug development in our programs. This is a key leadership role in MyoKardia and will serve as the internal and external face of the AF therapeutic area.
This position requires a hands-on, self-motivated, smart and emotionally intelligent individual who thrives in a fast-moving, dynamic environment within a complex and fast-changing environment.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Establishment of an integrated development approach leveraging emerging preclinical, translational and clinical sciences, including home based technologies, digital devices and applications of machine learning applied to digital devices to optimize the generation of clinical data.
- Strategic initiatives will address TA specific needs as well as lead the development and implementation of modern clinical data generation designs, including leading Development Core Functions focused on Digital Technologies (wearables and EKG monitoring) and refinement and or advancement employing machine learning and implementation for home monitoring.
- Support regulatory approval, label expansion, guideline recommendations and patient/physician adoption of MyoKardia AF therapeutic solutions utilizing clinical data generated by this team.
- Working closely with the Development Leadership Team and other MyoKardia senior leaders, this person will lead the development strategy and associated strategic initiatives to generate clinical data to develop and maximize the overall medical value of MyoKardia therapeutic solutions.
- Being effective in this role requires leadership skills to build new capabilities and strengthen existing core competencies, including collaborations within R&D, across MyoKardia and external experts and networks.
- Will lead and manage the Atrial Fibrillation (AF) therapeutic area including the hiring and development of the entire team of MDs and Clinical Scientists.
- Develop and lead the implementation of modern clinical generation using digital tools, machine learning applications and home-based technologies across MyoKardia TAs
- Partner with senior leaders within MyoKardia to ensure alignment on Development strategies of AF.
- Primary advocate for gaining support from the EC and PRC as appropriate
- Lead advocate for gaining support from Project team and PRC as appropriate
- Support the translational research team in identifying TCPs and TPPs and pre-candidate POC plan.
- Serves as a member of cross functional teams including project teams, sub teams and other relevant teams (Protocol Review Committee, Medical/Regulatory/Legal, etc.)
- Responsible for collaborating with medical affairs on medical conferences, advisory boards, and patient engagement activities
- Responsible for oversight of completion and closing out of Clinical Study reports
- Leads the development of clinical study protocols, amendments, informed consent forms, study guides, case report forms, and any other clinical research related documents and study reports
- Leads the clinical contribution to IND's, Investigational Brochures, Regulatory Briefing Documents, and other relevant documentation
- Takes primary medical responsibility for clinical study conduct and data analysis and interpretation, reporting and communication, including the review and analysis of any adverse events
- Assists with operational aspects of study conduct including site selection and activation, site investigator and staff training, budget planning and contract review
- Is responsible for communication with site-Principal Investigators, both individually and in Investigator Meetings. Will play a leading role in setting the agenda and presentations at Investigator and other Meetings.
- Contributes to the strategic planning, authoring and review of regulatory submissions and scientific data disclosures, as required
- Coordinates medical responses to support regulatory or IRB/Research Ethics Committee information requests
- Monitors subject/patient enrollment and, in an ongoing manner, monitor safety and efficacy data and identify potential safety signals in all studies as appropriate
- Ensures consistency of clinical content and scientific messages across publications and materials
- Use innovative technology, including state-of-the-art imaging, biomarker, and genetic analysis, to optimize patient response and safety in treatment with agents in the MyoKardia pipeline
- M.D. required, with certification in a primary medical specialty highly recommended; Cardiovascular Diseases or related specialty board eligibility or certification preferred
- Minimum 10 years' clinical/brand development experience working in the regulated medical products industry
- Experience collaborating with investigators and other study personnel, Key Opinion Leaders, Scientific Advisors, consultants, contractors, and CROs
- Experience working with the principles and techniques of data analysis, interpretation and clinical relevance
- Particular experience in FDA interactions and filings, Phase 1-3 trials, translational medicine and biomarkers/biomedical imaging preferred
- Proven track record of being a results oriented leader of cross functional teams and will have 10+ yrs. leading, managing, and developing people
- Solid understanding of Phase 1-3 drug development with relevant CV therapeutic area experience of 3 or more years
- Working knowledge of clinical research design principles, GCP/ICH requirements, and safety considerations
- Ability to plan and conduct Clinical Advisory Board and similar content-focused meetings
- Demonstrated ability to effectively work collaboratively in cross functional teams
- Strong interpersonal, communication (written and verbal), and organizational skills
- Able to proactively identify and solve problems under pressure
- Leadership: Experience leading and motivating teams in a matrix environment is required. Proven interpersonal skills with ability to influence, resolve conflict and drive decisions among internal cross functional teams, executive management, and external teams
- Strategic Agility: Ability to develop and execute complex strategies
- Collaboration/Relationship Management: Ability to effectively collaborate in and across multiple functions, and with internal and external stakeholders of various backgrounds and skill sets. Skilled in establishing a collaborative and respectful environment
- Influencing: Demonstrated ability of leading a matrixed team through influence. Proven track record of influence strategy, initiative(s) implementation, and decision-making. Proactively influences and motivates others to achieve objectives
- Decision Making: Strong decision-making skills taking multiple perspectives into account and analytical skills are required; exercises sound business judgment that has broad organizational impact
- Communication: Excellent communication skills (both orally and written) is critical to the success of the role
- Business Excellence: Good at developing the processes necessary to get things done, knows how to organize people and activities, and knows what to measure and how to measure. Demonstrated ability to interpret data into actionable items
- Negotiation: Proven negotiation skills that effectively drive discussions and decisions to desired end-results that have broad organizational impact
- Alignment: Proven track record of achieving alignment with internal and external stakeholders
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